IceCure Medical touts interventional radiology cryoablation study data


IceCure Medical yesterday released data from an interventional radiology study of its liquid-nitrogen-based cryoablation technology.

Results from the study were presented at the Annual European Association of Urology Congress in Barcelona, the Israel-based company said.

IceCure Medical’s ProSense cryoablation system uses liquid nitrogen technology for the treatment of benign and cancerous tumors through freezing, the company said.

“The ProSense system has already demonstrated excellent progress as a rapid, in-office solution for the treatment of breast tumors. This new data adds to our growing clinical evidence for its expanding use in the field of interventional oncology as a non-surgical alternative to treat cancer of the kidney, lung, bone, and prostate,” CEO Eyal Shamir said in a prepared statement.

Researchers explored the use of the ProSense system in treating 75 patients with 78 reported small kidney masses, IceCure said.

Data from the study indicated that the system was safe and effective at treating the small kidney tumors, with a 93% treatment success rate identified by lack of enhancement on computed tomography or magnetic resonance imaging at 1-year post treatment.

“The ProSense system enables a safe, efficient and short minimal-invasive procedure that preserves renal function. There were over 400,000 new cases world-wide in 2018. The ProSense system adds a viable option to treat renal cancer in patients who have at least one comorbidity, had surgeries in the past or are a subject to multiple renal masses,” principal study investigator Dr. Ofer Nativ of Bnei Zion Hospital Urology Department said in a press release.

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FDA approves Otimizer Smart heart failure device from Impulse Dynamics

Impulse DynamicsThe FDA today said it approved the Optimizer Smart heart failure device developed by Impulse Dynamics under its breakthrough device designation.

The Stuttgart, Germany-based company’s device is designed to remodel the myocardium to increase the heart’s efficiency using “cardiac contractility modulation” – non-excitatory electrical pulses delivered to the heart muscle. An FDA advisory panel last December recommended approval for Optimizer Smart, voting voted 12-1 on safety, 11-2 on efficacy and 12-0, with a single abstention, that its benefits outweigh the risks. The system has had CE Mark approval in the European Union since 2002.

The FDA indication covers patients with chronic, moderate-to-severe heart failure who can’t be treated with other devices.

“Patients with moderate-to-severe chronic heart failure have limited treatment options. And for those who are unable to be treated due to underlying conditions or who have not responded to available treatments, their quality of life may be impacted, with limits on the types of physical activities they can do,” FDA director of cardiovascular devices Dr. Bram Zuckerman said in prepared remarks. “The FDA recognized the unmet need for these patients and worked with the manufacturer through our breakthrough device program to efficiently bring this product to market, while ensuring it meets our regulatory requirements for safety and effectiveness.”

The federal safety watchdog said it based the approval on a pair of trials covering 389 patients, all of whom received optimal medical therapy; 191 or 49.1% were treated with the Optimizer Smart device. Patients with the implant showed improved six-minute walking tests and improved heart failure symptoms, the agency said.

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Abiomed’s stake in Shockwave is worth at least $58m

Abiomed, Shockwave MedicalThe $10 million Abiomed (NSDQ:ABMD) put into Shockwave Medical (NSDQ:SWAV) has paid off so far no matter how you slice it.

Shockwave raised nearly $97 million in an initial public offering earlier this month, inking a private-placement deal with Abiomed on the side for $10.0 million worth of SWAV shares at the $17-per-share IPO price. In a regulatory filing today, Santa Clara, Calif.-based Shockwave said Abiomed owns nearly 1.7 million shares, or a 6.0% stake.

With SWAV shares trading at $34.55 apiece today in mid-morning activity (up 4.8%), Danvers, Mass.-based Abiomed’s share would be worth roughly $58.7 million if it sold right now. Measured as a slice of Shockwave’s $1.19 billion market capitalization, that 6% stake’s value jumps to $71.4 million.

Shockwave is developing a device to treat calcified coronary lesions with sonic pressure waves. The deal with Abiomed, announced last December, includes collaboration on a training and education program in the U.S. and Germany.

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ACC 2019 Roundup – ReCor touts six-month Paradise renal denervation study results

ReCor Medical this week released “on-medication” results from the RADIANCE-HTN-SOLO clinical trial of its Paradise renal denervation system intended to treat uncontrolled hypertension, touting medication and blood pressure reductions at six months.

Results from the trial was presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans and were simultaneously published in the journal Circulation.

Study investigators said that the six month “on-meds” results followed two month “off-meds” results that had been previously released after patients met their blood pressure primary outcomes. Patients in that trial remained blinded to treatment assignment and were put back on medications following a recommended, pre-set, stepped care, medical titration protocol.

“Professor Michel Azizi, my Co-PI for the RADIANCE-HTN study, the RADIANCE-HTN Steering Committee and I are very pleased to report the 6 month ‘on-meds’ results from the SOLO cohort of the study. These results are unique in that they represent blinded randomized data demonstrating that ultrasound renal denervation may have the potential to serve as an important adjunct to medications to lower blood pressure. We believe that in addition to the previously presented SOLO results in patients who were ‘off’ medications, these new data contribute to the growing body of evidence demonstrating that the Paradise System can lower blood pressure, either alone or in combination with anti-hypertensive medications. If confirmed in the larger and ongoing RADIANCE II trial, this therapy would have the potential to help patients and physicians reach their blood pressure goals – something that is frequently not achieved in clinical practice,” co-principal investigator Dr. Ajay Kirtane of Columbia University Irving Medical Center said in a prepared statement.

Results indicated that patients treated with the ReCor Paradise Ultrasound denervation system were prescribed fewer anti-hypertensive medications than those treated with a sham procedure, ReCor Medical said.

Treated patients also experienced greater blood pressure drops than those in the sham arm, with reductions maintained at six months and no reports of major adverse events.

“ReCor is encouraged by the SOLO 6 month outcome data as it is the first randomized, blinded, sham-controlled evidence of the effectiveness of the Paradise renal denervation system in combination with added anti-hypertensive medication.  These data demonstrate the 6 month durability of the blood pressure lowering effect of the Paradise renal denervation system, either alone or in combination with medications. We are also excited that we have begun to randomize subjects in our RADIANCE-II pivotal study, which we plan to complete in 2020.  The combination of our independent, blinded and sham-controlled RADIANCE-HTN SOLO and TRIO studies, the REQUIRE study being run in Japan and Korea, and our pivotal RADIANCE-II study will provide safety and efficacy outcomes on more than 600 patients, covering a broad range of patients with hypertension.  If successful, we hope that, in the future, these studies may support an important new treatment option for millions of hypertensive patients worldwide,” CEO Andrew Weiss said in a press release.

 HeartFlow touts ADVANCE FFRct trial data

HeartFlow this week presented results from the ADVANCE trial of its FFRct Analysis system, touting its ability to identify patients at low risk of cardiovascular events to reduce invasive testing.

Results from the trial were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans and simultaneously published in the Journal of the American College of Cardiology: Cardiovascular Imaging.

“These findings provide reassurance regarding the safety of patient management utilizing a FFRct-guided decision pathway, particularly in lower-risk patients who did not undergo an invasive evaluation. By adding the HeartFlow FFRct to our available resources for diagnosing stable coronary disease, we are able to provide patients with better care as we efficiently evaluate risk in patients getting a coronary CTA, more precisely stratify patients and improve efficiency in the cath lab,” Dr. Manesh Patel, of Duke University School of Medicine said in a prepared statement.

Study investigators in the more than 5,000-patient registry trial evaluated the use of FFRct values derived from the HeartFlow analysis to help determine patient’s risk of adverse cardiovascular events and for treatment planning. Patients in the trial underwent a coronary computed tomography angiogram with HeartFlow Analysis to follow when needed.

The majority of patients in the trial who received a negative HeartFlow Analysis received medical therapy and did not have to undergo invasive testing and treatment, HeartFlow said.

Study researchers reported a 0.2% rate of cardiovascular death or heart attack amongst the negatively-screened patients at one year, four times lower than patients who received a positive HeartFlow Analysis. Negatively-screened patients also had a low rate of revascularization through 90 days and negligible need for revascularization afterwards, the company said.

“The one-year results from ADVANCE are largely unchanged from the previously-presented 90-day results, which reinforces the durable utility of using coronary CTA as a front-line diagnostic test and incorporating the HeartFlow Analysis in a real-world patient population. By providing functional information, the HeartFlow Analysis is able to complement the anatomical information provided by a coronary CTA and enable the physician to have a more complete picture of the patient’s heart health, and thus provide more personalized care for the patient,” chief medical officer Dr. Campbell Rogers said in a prepared release.

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 AliveCor releases data from multiple KardiaMobile ECG studies

AliveCor yesterday released data from three new studies of its KardiaMobile mobile electrocardiogram technology, touting its clinical utility and ability to streamline workflows.

Data from two trials were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans while another was published in Lancet’s EClinicalMedicine journal, Mountain View, Calif.-based AliveCor said.

Results from the EClinicalMedicine-published 243-patient trial performed at the University of Edinburgh and NHS Lothian indicated that ECGs taken with the KardiaMobile after discharge allowed doctors to diagnose 56% of patients in 9.5 days on average, higher than a 10% diagnosis rate and an average of 43 days reported with standard-of-care treatment. Data also indicated a cost-per-patient reduction of approximately $1,200, AliveCor said.

In one ACC 2019 presentation, AliveCor said that it touted the capabilities of its remote patient monitoring platform and its ability to integrate images from the KardiaPro mobile ECG into an EPIC electronic health records platform. The company also presented the latest version of the KardiaPro, which it says now supports reimbursement under the newest remote patient monitoring CPT codes.

The company also presented data on its KardiaMobile Gen 2 six-lead mobile ECG that is currently pending FDA 510(k) clearance, touting its ability to accurately measure the QT interval, which is associated with sudden cardiac death when prolonged. The company said that the system was trained off of data from over 200,000 Mayo Clinic patients to predict the QT interval.

AliveCor said that the QT prediction from the KardiaMobile Gen 2 ECG data was comparable to QT measured from a traditional 12-lead ECG.

“KardiaMobile is the most clinically validated mobile ECG in the world,” said Dr. Jacqueline Shreibati, Chief Medical Officer at AliveCor. “Every day, physicians and patients around the globe reaffirm AliveCor’s role in improving patient outcomes. AliveCor is proud to be involved in high-quality clinical research, including randomized controlled trials, and prospective validation studies of AI algorithms.”

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 Livongo touts BP drops in Livongo for Hypertension trial

Livongo late last week presented results from a study exploring the use of its Livongo for Hypertension solution’s ability to reduce blood pressure in patients with diabetes and uncontrolled high blood pressure.

Data from the trial was presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans, the Mountain View, Calif.-based company said.

Livongo said that its Livongo for Hypertension solution includes a smartphone app for remote blood pressure monitoring, tips on healthy living and the ability to connect with a health coach.

Participants in the trial measured their blood pressure on average four times a week, with data automatically transmitted to Livongo’s Applied Health Signals platform, the company said.

Study researchers said that they recruited 708 individuals with diabetes and a starting blood pressure of greater than 130/80 mm HG for the trial, and that patients had an average reduction of 11.2 mm Hg for their systolic pressure and a decline of 5.2mm Hg to their diastolic pressure at six weeks.

“By giving our Members the opportunity to monitor their blood pressure readings at home and offering personalized insights and coaching to help them better understand their health, together we were able to drive meaningful behavior change that led to significant clinical outcomes at six weeks without the use of medication. This study effectively shows that by giving health consumers the tools they need to better manage their health, we can empower them to live healthier lives,” senior study author and chief medical officer Dr. Bimal Shah said in a prepared statement.

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 Neovasc presents Reducer data

Neovasc (NSDQ:NVCN) said today that it released data on its Neovasc Reducer device during the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans.

During the session, researchers explored the treatment of refractory angina in patients with no options, Vancouver-based Neovasc said, touting its Reducer’s ability to narrow the coronary sinus in refractory angina patients.

“We are pleased that today’s ACC.19 session included an overview of our Reducer and its efficiency in narrowing the coronary sinus in refractory angina patients, which has resulted in an improvement in symptoms and quality of life for patients with refractory angina who were not candidates for revascularization.  A portion of the data discussed during the session was originally published in the New England Journal of Medicine in February 2015. Looking at the participants in this session, we see growing interest for the Reducer among leading cardiologists; Professor Thomas Luscher, who has treated patients with Reducer within his practice in Europe and co-authored a published paper on the Reducer, presented the Reducer data at ACC.19 and Dr. Tim Henry of Cedars-Sinai, who has been a strong supporter of generating additional data for the Reducer in the U.S., chaired the session,” CEO Fred Colen said in a press release.

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ACC 2019 Roundup: Abiomed Impella RP post-market study shows benefit in select patient group

Abiomed (NSDQ:ABMD) today released 18-month post-approval study data from patients treated with its Impella RP, touting a benefit to survival for specifically selected “Recover Right” protocol patients.

Results from the study were presented at the American College of Cardiology’s 68th Annual Scientific Sessions, the Danvers, Mass.-based company said.

The review follows a release posted by the FDA last month warning of a 17.4% survival rate with the Impella RP heart pump system, approximately 55% lower than the rate noted in the premarket study of the device.

Abiomed said that it met with the FDA who confirmed the classification of patients treated with the Impella RP into two categories: patients treated under the “Recover Right” protocol, which follows inclusion and exclusion criteria used in the company’s premarket approval study of the device, and “salvage support” patients, or those who have experienced more than 48 hours in cardiogenic shock from right side failure.

“When a patient is in right heart failure, Impella RP allows the heart to rest and recovers the heart’s ability to pump blood. The Impella RP is an effective treatment for patients who receive a timely implant and meet the Recover Right inclusion and exclusion criteria,” Dr. David Wohns of Spectrum Health said in a prepared statement.

When separated into categories, Abiomed said that patients under the “Recover Right” protocol had survival rates of 64%, while those classified as “salvage support” had only an 11% survival rate.

The population of “salvage support” patients was 28, while only 14 patients fall under the “Recover Right” protocol, Abiomed said. Data from Abiomed’s PMA Impella RP study indicated a survival rate of 73%.

“The post-approval study data is analogous to our own independent data from multiple hospitals in the Cardiogenic Shock Working Group, which found an approximate 80% survival rate when the Impella RP was used in cardiogenic shock patients who met inclusion criteria from the Recover Right Study. Data like these highlight how the use of algorithms to recognize right sided failure and protocols for early hemodynamic support can help improve outcomes for cardiogenic shock patients,” Dr. Navin Kapur of Tufts Medical Center’s CardioVascular Center for Research and Innovation said in a prepared release.

The company said that the Impella RP is the only device submitting post-approval study data on real-world patient outcomes, including salvage utilization, and that its patient population will continue to be studied in the ongoing cVAD study.

Abiomed won clearance for the Impella RP in September of 2017, making it the only such device cleared for right heart failure.

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ACC 2019: Abbott touts reduced stroke, bleeding and pump-clotting in HeartMate 3 trial

ACC 2019, Abbott

Abbott (NYSE:ABT) yesterday presented data from a new trial of its HeartMate 3 left ventricular assist device, touting a reduced rate of strokes, pump-related blood clots and bleeding episodes at two years as compared with the previous generation HeartMate II.

Data in the trial was presented at the American College of Cardiology’s 68th Annual Scientific Session 2019 in New Orleans and published simultaneously in the New England Journal of Medicine, the Chicago-area medical device company said.

Abbott touted its HeartMate 3 as the first implantable mechanical pump using fully magnetic levitation technology, making it frictionless and removing the need for mechanical bearings.

Study investigators recruited a total of 1,028 patients with severe heart failure for its MOMENTUM-3 trial at 69 U.S. centers. Patients in the trial either needed an LVAD as a bridge to a heart transplant or relied on the LVAD as a lifelong therapy, Edwards said.

Patients in the trial were randomized to receive either the HeartMate 3 or a HeartMate II system, and all received blood-thinning medications following surgery and were taking between 81 to 325 mg of Aspirin daily, the company said.

Data presented came from two pre-specified interim analysis and a final analysis at two-years post enrollment, Edwards said.

At two years, 74.7% of HeartMate 3 patients met the primary endpoint of the trial, compared with only 60.6% of patients with the HeartMate II. Pump replacement rates at two years was 2.3% for HeartMate 3 patients versus 11.3% for patients with a HeartMate II.

Rates of pump clotting were significantly lower for HeartMate 3 patients at 1.4% versus 13.9% for patients with HeartMate II devices. Rates of disabling stroke were closer between groups, at 5% for HeartMate 3 patients versus 7.5% for HeartMate II patients.

Rates of bleeding and gastrointestinal bleeding were reported at 43.7% and 24.5% respectively for HeartMate III patients, higher than the 55% and 30.9% reported for Heartmate II patients.

Patients treated with the HeartMate 3 spent on average 48 more days on LVAD support outside of a hospital than their Heartmate II counterparts and fewer days in the hospital after readmission, at 13 days versus 18 days, respectively.

Researchers noted an increased risk of infections at two years, and commented that they were working with infection disease experts to explore new ways to reduce infection susceptibility.

Study investigators said they plan to follow patients in the trial out to three years, and that they are looking to develop a new trial to explore how to optimize medical therapy for advanced heart failure patients.

“These final results from what is by far the largest LVAD trial ever conducted demonstrate the clinical superiority of the HeartMate 3 compared with its predecessor, the HeartMate II. We have shown a decrease in adverse events that uniquely occur due to the interface between the patient and the mechanical pump. These include a consistent and reliable reduction in strokes of all kinds and severity with the HeartMate 3 but also a remarkable reduction in the rate of pump-related blood clots and significant reductions in all types of bleeding, especially gastrointestinal bleeding. In addition to having significantly lower rates of adverse events, patients who received the HeartMate 3 had a lower rate of readmission to the hospital and spent fewer days in the hospital when they were readmitted,” lead author Dr. Mandeep Mehra of Brigham and Women’s Hospital said in a press release.

Mehra added that based on the results, he believes that the HeartMate 3 should be considered the standard of care for patients with advanced heart failure who do not respond to guideline-directed medical therapy.

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ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications

ACC 2019, Medtronic, Edwards

Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology in the U.S.

Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine.

Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at intermediate and high risk for death and complications associated with surgery.

The results, both from trials exploring use of TAVR devices in low-risk patients, earned a standing ovation for presenters at the conference, according to a Medscape report.

In the Medtronic-sponsored Evolut Low Risk study, researchers reported that the use of its self-expanding TAVR system, when compared to open-heart surgery for valve replacements, had a similar rate of disabling stroke or death from any cause at two years at 5.3% versus 6.7%, respectively.

“We now have a minimally invasive procedure that is as good as or better than surgery, while at the same time allowing most patients to be out of the hospital within a few days and be back to their normal activities within a week, and that’s pretty important,” study senior author Dr. Michael Reardon of Houston Methodist Hospital said in a press release.

In the trial, study investigators recruited 1,468 patients with severe, symptomatic aortic stenosis who were deemed to be at low risk of surgery. Patients either received TAVR treatments with one of three Medtronic self-expanding devices, the CoreValve, Evolut R and Evolut Pro, or underwent surgical aortic valve replacement with biopsothetic surgical valves.

The majority of patients in the trial, 74.1%, received Fridley, Minn.-based Medtronic’s Evolut R, while the third-generation Evolut Pro was used in 22.3% and the CoreValve was used in 3.6% of patients, researchers report.

Study researchers said that groups were well-matched in terms of baseline characteristics, with a 2-to-1 ratio of men to women.

At 30 days, TAVR was shown to be statistically superior to SAVR, with a 0.8% rate of disabling stroke or all-cause mortality versus 2.6%, respectively. Rates of death at one month were not statistically different between TAVR and SAVR at 1.3% and 0.5%, respectively, according to the study.

TAVR maintained its superiority to open heart surgery for major stroke at one year, at 0.8% for TAVR patients versus 2.4% in SAVR patients. All-cause mortality rates were similar at 2.4% for TAVR versus 3% for SAVR, while hospitalization and heart failure rates were are 3.2% for TAVR versus a higher 6.5% for SAVR patients.

Quality of life assessments using the Kansas City Cardiomyopathy Questionnaire were higher for TAVR patients than SAVR at 20 versus 9.1 at one month post-procedure, with scores evening out at one year to 22.2 for TAVR and 20.9 for SAVR patients, according to the study.

“TAVR beat surgery at 30 days for mortality or disabling stroke, quality of life and time in the hospital. In other words, you’re more likely to be alive without a disabling stroke, get out of the hospital sooner— in half the time—and have a better quality of life one month after getting a new valve. The mean age of patients in this study was 74, so while this is still not a young group of patients, many of them are very active and whether it be in their professional or social lives, getting back to full range of daily activities is very important to them. At one year, patients with TAVR were more likely than surgery patients to be alive, without a disabling stroke and without a hospital admission for heart failure,” Reardon said in a prepared statement.

Data from echocardiograms indicated that TAVR valves may work better than SAVR valves, with an orifice measurement of 2.2 cm2 vs 2.0 cm2, respectively, and lower mean gradients than surgery at all time points in the trial, according to study data.

Similar to earlier studies, TAVR patients had had more pacemakers and moderate to severe paravalvular leakage, more vascular injuries including dissection, cardiac perforation and access site injuries. SAVR patients reported more cases of atrial fibrillation, transfusions and acute kidney injury, according to the report.

Researchers in the trial plan to follow patients out to 10 years, exploring long-term data as well as cost-effectiveness. Study investigators said that the study was limited by short follow-up time, and that the trial excluded patients with bicuspid aortic valves and those with anatomic incompatibilities.

“We’ve now looked at a broad risk spectrum of patients—those at high, intermediate and low surgical risk—and these series of trials have shown that TAVR is better than or as good as surgery in terms of disabling strokes and deaths from all causes. When we look at secondary outcomes of quality of life and functional recovery, these seem to favor TAVR at this point. Given this data, it now seems reasonable to consider moving TAVR in low risk patients to a class I guideline indication on par with surgery for patients with severe aortic stenosis,” Reardon said in prepared remarks.

In a separate presentation on the same day, Edwards Lifesciences touted that data from its PARTNER 3 study of its Sapien 3 TAVR system indicated a reduction in death, stroke and rehospitalization of 46% at one year.

A total of 1,000 patients with severe aortic stenosis deemed at low risk for surgery were recruited for the PARTNER 3 trial, the Irvine, Calif.-based company said. The group was younger, at 73 years average, with fewer co-morbid conditions and fewer symptoms than previous PARTNER trials, with a similar two-to-one ratio of men to women.

The primary endpoint of the trial was a combined rate of all-cause death, any stroke and re-hospitalizations at one-year post procedure, Edwards said.

Results from the trial indicated a 1% mortality rate for TAVR patients versus 2.5% in SAVR patients, with a 1.2% stroke risk for TAVR patients versus a higher 3.1% rate for SAVR patients. SAVR patients were also more likely to be rehospitalized, at an 11% rate, versus only 7.3% for TAVR patients.

“This is a landmark study because it involves 80 percent of the people who are currently being treated with surgery for aortic stenosis. Our hope was that TAVR would be non-inferior or comparable to surgery, and we were surprised to find an almost 50 percent reduction in the primary endpoint, from 15.1% in the surgical group to 8.5% with TAVR. This is beyond anything we could have expected, mostly because surgery is so good in treating aortic stenosis in these low risk patients. Taken by themselves, each component of the primary endpoint also favored TAVR, which is confirmatory evidence of the outcome,” lead study author Dr. Martin Leon of the New York-Presbyterian/Columbia University Irving Medical Center said in a press release.

Evaluation of secondary endpoints indicated that hospital stay length was reduced from seven to three days for TAVR patients, and that TAVR patients had more rapid 30-day functional recovery based on six-minute walk tests and quality of life measurements.

Post-operative or new onset atrial fibrillation was reported in approximately 40% of SAVR patients, compared to only 5% in TAVR patients. Major vascular complications were also similar between groups, Edwards said.

Patients in the TAVR arm were more likely to need new permanent pacemakers, at 6.5% for TAVR patients versus 4% for SAVR patients, while rates of moderate to severe paravalvular leaks were similar between groups.

“Surgery eventually catches up to TAVR in terms of functional recovery and quality of life, but it takes several months. TAVR is a less invasive procedure, so we expect an earlier return to normal daily activities compared with surgery. There has also been an evolution of TAVR technology, increased operator experience and enhanced procedural techniques, all of which combine to lower complications after TAVR especially in the lowest risk patients,” Leon said in a prepared statement.

Researchers in the trial said it was limited by its breadth and said that longer-term follow-ups would be needed to explore the viability of TAVR devices. Study investigators added that they plan to follow patients in the trial out to ten years.

“The results of this trial in low risk patients indicates that the choice of TAVR versus surgery for severe aortic stenosis should be independent of surgical risk profile assessments. The combined rate of death and disabling stroke at one year was only 1 percent with TAVR, which was an unexpectedly favorable outcome. Based on these findings, the choice of TAVR versus surgery should be a shared decision-making process that respects patient preferences and considers some of the knowledge gaps, especially in treating young patients,” Leon said in prepared remarks.

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FDA updates docs on review of paclitaxel devices for PAD

FDA-logo-newThe FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices.

In a letter to healthcare providers, the U.S. regulatory agency reported that there was a 50% increased risk of mortality in people treated with paclitaxel-coated devices versus those treated with control devices in the three trials with five-year follow-up data.

Get the full story at our sister site, Drug Delivery Business News.

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Apple touts results from massive AF-detection Apple Watch study

Apple Watch Series 4

Apple (NSDQ:AAPL) today released data from its 419,297-patient Apple Heart Study, showing that the device is capable of aiding in the detection of atrial fibrillation using its light-sensor based technology.

Results from the study were released today at the American College of Cardiology’s 68th Annual Scientific Session in New Orleans.

The study was designed to test how well Apple’s Watch could identify and prompt clinical evaluations for atrial fibrillation, the Cupertino, Calif.-based company said.

In the study, data was collected from a mobile application using Apple Watch’s photoplethysmography technology to intermittently measure blood flow activity and detect changes that could indicate an irregular contraction or heartbeat. That data, in the form of a tachogram, was then analyzed by an algorithm designed to detect irregular heart rhythms.

If the algorithm detected an irregularity, the Watch and its associated application then sent a notification to the study participant.

Researchers compared the notifications to subsequent results from a seven-day worn ECG patch, analyzing how well the algorithm on the watch matched the ECG findings, as well as the percentage of notified patients who  sought medical help through the application.

“The app continuously gathers data in the background without the wearer of the device doing anything, so it’s very opportunistic in this way. [Overall], this study improves our understanding of how this wearable technology and app works in the real-world setting and how well the technology can detect long periods of AFib,” co-principal investigator Dr. Mintu Turakhia of the Stanford School of Medicine said in a press release.

Only 0.5%, or approximately 2,100 individuals, received an irregular pulse notification. In total, 658 patients were sent a patch, of which 450 returned the patch and were included in the analysis.

Data indicates that 34% of the trial participants who were both sent a notification and had data collected via ECG patch were diagnosed as having atrial fibrillation.

“AFib can come and go, particularly early on in the course of the disease. It’s not surprising for it to go undetected in subsequent ECG patch monitoring. So while only 34 percent of people who were still having [signs of] AFib on the ambulatory ECG, that doesn’t mean that 66 percent didn’t have AFib. It just means that AFib may not have been there at the time,” Turakhia said in a prepared release.

Of the patients who received irregular pulse notifications, approximately half ended up contacting the study doctors, though others were assumed to have sought help elsewhere. Post-study surveys indicated that approximately 57% of individuals who received alerts said they sought medical attention outside the study.

Data from the trial also indicated a low rate of notifications for individuals under 40 years of age, at 0.16%, compared to just over 3% in patients over 65.

“Notifications of heart rhythm irregularities were low, an important finding given concerns about over notification, and we were able to see what happened downstream after participants received a notification,” Turakhia said in a prepared statement.

Limitations of the study included a reliance on self-reported data from participants and the failure to reach target enrollment of 500,000 participants, with a hoped for population of 75,000 individuals age 65 and over, researchers said.

Researchers said they are hopeful that the trial will serve as groundwork for future studies that look to leverage wearable technologies, and added that the next step for the study will be to explore how the monitoring tech can be used alongside other technologies, including real-time ECG, to manage heart rhythm problems.

“It really represents a paradigm shift for how clinical studies can be conducted. We don’t have to bring people into a brick and mortar clinic and give the study intervention,” Turakhia said in a prepared release.

In January, Johnson & Johnsons (NYSE:JNJJanssen and Apple said that they inked a deal to study if a mobile application from J&J, in combination with the Apple Watch’s ECG app and irregular rhythm notifications, can improve outcomes for people living with atrial fibrillation.

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FDA ramps up scrutiny of materials in medical devices

(Image by Michael Longmire on Unsplash)

The FDA said today it has begun more closely scrutinizing the roles of certain materials associated with harm to patients who have breast implants, nitinol-containing devices, metal-on-metal hip implants and devices made from animal-derived substances.

It’s the latest in a series of statements the agency has issued following increasingly harsh public criticism of its efforts to regulate the medical device industry. In the past year, Netflix’s documentary “The Bleeding Edge” and the International Consortium of Investigative Journalists’ “The Implant Files” series ripped the agency and the industry over patient injuries attributed to faulty devices. The FDA has been particularly faulted for its 510(k) clearance pathway, under which it allows devices that are similar to previously approved technology to undergo a less strenuous review before they can be sold.

Get the full story on our sister site, Medical Design & Outsourcing.

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