Conformal Medical launches LAA seal study

Conformal MedicalConformal Medical said yesterday that it launched an investigational device exemption trial for a device designed to seal off the heart’s left atrial appendage to help prevent stroke in atrial fibrillation patients.

Nashua, N.H.-based Conformal’s device is designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia. The 45-patient, single-arm study is designed to evaluate the device’s performance, with an estimated primary completion date of April 2020 and a final completion date of June 2025, according to

The primary outcome is freedom from adverse events at 45 days, defined as all-cause mortality, ischemic stroke, systemic thromboembolism, device- or procedure-related adverse events requiring open cardiac surgery or major endovascular intervention. Secondary outcomes include closure success at 45 days, 6 months and a year and major adverse events measured annually out to five years.

Conformal said the first-in-human use of the LAA seal, in a 63-year-old mountain biker with a history of bleeding episodes with anticoagulation drugs, was performed at the New York-Presbyterian/Columbia University Medical Center in New York City by Dr. Robert Sommer. The patient was discharged the day after his successful implantation on dual anti-platelet therapy per the study’s protocol, the company said.

“First-in-human use marks an important milestone for advancing our approach to stroke prevention,” president & CEO Andy Levine said in prepared remarks. “The experienced team at Columbia is providing valuable insights for optimizing the care of their patients.”

“It is exciting to participate in the first-in-human use of the Conformal device. The form-fitting seal is a promising advance in LAA closure for stroke prevention,” Sommer added.

“Columbia is excited to be the first to introduce this technology to patients,” Interventional Vascular Therapy Center director Dr. Martin Leon said. “I applaud Conformal’s commitment to utilize the FDA’s EFS Program. The ability to participate in early feasibility studies is important for the U.S. device ecosystem as we strive to develop new therapies to better serve our patients.”

Last December Conformal raised $9 million in a Series B round led by Catalyst Health Ventures that included some of its Series A investors.

Tioga Medical raises $15m to support transcath mitral, tricuspid valve tech

Tioga Medical

Newly formed Shifamed portfolio company Tioga Medical said today that it closed a $15 million Series A preferred stock financing round to support its transcatheter mitral and tricuspid valve replacement technology.

The Campbell, Calif.-based company said that it is developing novel transcatheter valve replacement technology intended to be simpler and less invasive than current mitral and tricuspid valve replacement approaches.

Tioga Medical will initially focus on technology for mitral valve replacement, stating that there is a “significant clinical need for less invasive, transcatheter approaches for mitral valve replacement.”

“We are extremely pleased to close this round of financing with such strong support from our investors. This round allows us to build out a world class team and dramatically accelerate the progress of our novel mitral valve and delivery system before we leverage the technology for the tricuspid application,” prez & CEO Mike Dineen said in a prepared statement.

The Series A round was led by The Capital Partnership and joined by Cormorant Healthcare Fund, AMED Ventures and Shangby Capital. Tioga Medical said that funds from the round will be used to advance its pre-clinical and clinical development programs.

“The proprietary Tioga technology represents a truly innovative solution to a difficult clinical problem in the structural heart space. TCP is excited to partner with a team with a strong track record of innovative medtech solutions. We believe this combination positions Tioga as an important, up-and-coming player in the mitral and tricuspid valve markets,” TCP private investments head Casey Gordon said in a press release.

Money in the round came from 23 unnamed sources, with the first date of sale noted as having occurred on March 12, according to a recently posted SEC filing.

Tricuspid valve repair device maker CroíValve raises $4m


Early stage tricuspid valve repair device developer CroíValve has raised approximately $3.6 million (EU €3.2 million) in an oversubscribed seed financing round, according to a report from the Irish Times.

CroíValve is developing a novel percutaneous solution intended to treat tricuspid regurgitation that seals the central gap between the native valve leaflets to prevent regurgitation, according to the company’s website.

The funding round was led by the business angel network HBAN and joined by Atlantic Bridge University Fund, Enterprise Ireland, Seán O’Sullivan’s SOSV and a total of 48 angel investors, according to the report.

CroíValve said it plans to use funds raised in the round to support continued development of the device.

“We welcome the investors’ support in accelerating our development efforts and look forward to working together to bring this exciting technology to patients. In doing so we are currently building our team, particularly in the area of R&D, and by year-end 2019 we will have grown to a company of 10,” founder Dr. Lucy O’Keeffe said, according to the Irish Times.

In connection with the funding round, former Boston Scientific exec and HBAN syndicate member Dr. Bernard Collins was named as board chair, according to the report.

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CMS touts ‘more flexibility’ in new TAVR coverage requirements

The Centers for Medicare and Medicaid Services have proposed new policy that could expand the use of transcatheter aortic valve replacement procedures, touting that it may provide more flexibility for starting and maintaining TAVR programs.

The original National Coverage Determination for TAVR procedures was cleared in 2012, when the technology and associated procedure was still new. The new policy from CMS looks to update requirements based on new information about the safety and viability of the procedures.

The new proposal, released yesterday, would reduce the number of cardiac surgeons required to independently examine and evaluate patient suitability for open aortic valve replacement surgery or TAVR from two to one.

“We believe this modification is appropriate given the advancements and progress made since 2012 as TAVR becomes more widely performed,” CMS wrote in its proposal.

Volume requirements for existing TAVR programs at hospitals looking to receive CMS reimbursement were raised slightly, according to the new proposal. Previously, hospitals were only required to perform 20 aortic valve replacements per year or 40 per two years – that requirement has been more than doubled to either 50 AVRs per year or 100 AVRs per two years.

For new programs looking to begin TAVR programs, the volume requirements stayed mostly the same, but language was shifted from 50 total AVRs per year to 50 open heart surgeries in the year prior to the program launch and at least 20 aortic valve related procedures in the two years prior to launch.

“When reassessing this requirement, CMS endeavored to balance ensuring hospitals have the experience and capabilities to handle complex structural heart disease cases while limiting the burden and barriers unnecessary requirements may have on both hospitals and patients flexibility. Therefore CMS proposes to maintain the annual volume of cases (≥ 50) in the previous year prior to TAVR but have provided flexibility on how that is met,” CMS wrote in its proposal.

In a press release, CMS said it met with “numerous stakeholders” as it sought new requirements for providers to perform a certain volume of heart procedures. The agency said that the volume procedures are included “given the link between heart procedure volume and patient outcomes in the medical literature and the risks from receiving care in low-volume settings.”

CMS added that it believes the new decisions will provide “more flexibility” in how providers meet those requirements, and that it reflects the “latest evidence on volume and outcomes.”

“CMS must continually refine our policies and requirements in light of emerging evidence. Today’s decision updates the requirements for hospitals and physicians to perform TAVR to ensure these requirements are in line with the latest research on patient outcomes, in order to broaden access to care while safeguarding quality and safety for Medicare beneficiaries,” CMS Administrator Seema Verma said in a press release.

The agency also said it is looking to gather more information about metrics other than volume that could be used to asses quality and safety, and said it is “specifically proposing a question regarding the relationship between other metrics and patient health outcomes, which could inform a future change to replace the volume criteria with a different metric.”

Earlier this month, results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) TAVR 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.

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Homeland Security details vulnerabilities in Medtronic ICD, CRT-Ds, CareLink devices

Medtronic logo updated

The U.S. Dept. of Homeland Security today released a medical advisory warning of exploits within a number of Medtronic (NYSE:MDT) implanted cardiac devices and associated equipment that could allow an attacker to affect the functionality of the devices or intercept transmitted sensitive data.

The vulnerability affects Fridley, Minn.-based Medtronic devices using its Conexus radio frequency telemetry protocol, according to the release, and requires only a low level of skill and adjacent access to exploit.

Successful exploitation could allow an outside actor to “interfere with, generate, modify, or intercept” the RF communication of the Conexus telemetry system, the HHS said.

To do so, an attacker would need an RF device capable of transmitting or receiving Conexus telemetry communication, to be in adjacent short-range of the products and for the products to be in states where RF functionality is active, according to the release.

Before the device is implanted and during follow-up clinic visits, Conexus telemetry sessions require initiation by an inductive protocol, the HHS said. Outside of those environments, the RF radio is only enabled for brief periods of time to support follow-up transmissions and “other operational safety notifications.”

The HHS warned that the Conexus telemetry protocol does not implement authentication or authorization, or encryption.

The exploit affects Medtronic devices that use its Conexus telemetry protocol, according to the warning. Affected devices include all models of the Amplia CRT-D, Claria CRT-D, Compia CRT-D, Concerto CRT-D, Concerto II CRT-D, Consulta CRT-D, Evera ICD, Maximo II CRT-D and ICD, Mirro ICD, Nayamed ND ICD, Primo ICD, Protecta ICD and CRT-D, Secura ICD, Virtuoso ICD, Virtuoso II ICD, Visia AF ICD, Viva CRT-D, the CareLink 2090 Programmer, the 2490C version of its CareLink Monitor and versions 24950 and 24952 of its MyCareLink Monitor.

Medtronic has implemented additional controls for monitoring and responding to improper use of the Conexus telemetry protocol by affected devices, according to the release, and is developing further mitigations that will require regulatory approval.

A Medtronic spokesperson said that to date, no cyberattack, privacy breach or patient harm has been observed or associated with the issues.

The company said that it is developing a series of software updates to better secure the wireless communication affected by the issues, with the first update expected to launch later this year, subject to regulatory approvals.

Medtronic said that it, and the FDA, recommend that patients and physicians continue to use the devices as intended.

Last October, Medtronic disabled internet updates for approximately 34,000 CareLink devices designed for accessing and programming implanted pacemakers due to cybersecurity vulnerabilities with the systems.

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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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Biotronik wins FDA nod for Acticor, Rivacor high-voltage tachycardia devices

Biotronik logo

Biotronik said yesterday it won FDA approval for its Acticor and Rivacor high-voltage cardiac rhythm management devices intended for treating patients with cardiac arrhythmias.

The clearance covers the Berlin, Germany based company’s Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX devices.

“When determining the best treatment plan for each patient, we assess individual needs and select a device system that provides optimal therapy programming with critical diagnostic features. We are often forced to choose between important features, which could compromise optimal patient care. The approval of Acticor and Rivacor offers choices to avoid this compromise. Intelligent software built into these devices enables us to assess disease states and respond accordingly with flexibility and customization. These devices offer sophisticated programming and automation as well as longer battery life, smaller size, and greater MRI access (3 Tesla). Our hope is that this will be a significant advance in device therapy and empower us to improve patient care while reducing long-term risk,” cardiac electrophysiologist Dr. Larry Chinitz said in a prepared statement.

Biotronik said that its Acticor and Rivacor systems include more diagnostic and therapeutic capabilities in a smaller form factor with extended battery longevity, and added that both devices have 3 Tesla MR-conditional labeling. Both systems are also equipped with the company’s home monitoring technology which Biotronik claims reduces all-cause mortality due to heart failure by 60%.

“Simplifying care through exceptional diagnostics and automated therapy is another example of how Biotronik continues to help physicians provide unmatched patient care. The Acticor and Rivacor device systems reflect Biotronik’s commitment to engineering solutions with profound positive impact for patients, physicians and health systems. We remain focused on bringing cardiac solutions to the US market that streamline processes and improve the ability to deliver care without compromise. There isn’t anything on the market that compares to Acticor and Rivacor,” prez Ryan Walters said in a press release.

Last month, Biotronik said that it won FDA approval for its for its Orsiro drug-eluting stent, touting it as the first and only ultrathin DES to outperform Abbott‘s (NYSE:ABT) Xience.

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Abbott wins expanded indications for MitraClip

Abbott's Mitraclip

The FDA today said that it granted Abbott (NYSE:ABT) a new indication for its MitraClip system, expanding coverage of the device to patients with normal mitral valves with diminished left heart function.

The indication expands upon the original approval, which the Chicago-area medical device maker won in 2013, clearing it for use in reducing mitral regurgitation in patients with mitral valve abnormalities whose risks for mitral valve surgery were prohibitive.

With its new clearance, the MitraClip is cleared for use for patients with normal mitral valves who develop heart failure symptoms and moderate-to-severe or severe mitral regurgitation due to diminished left heart function despite treatment with optimal medical therapy.

The agency said that the approval will allow a small percentage of patients with chronic heart conditions and moderate-to-severe or severe secondary mitral regurgitation to be candidates for treatment with the MitraClip alongside optimal medical therapy.

The new approval came based on results from a 614-patient study of the device in patients with moderate-to-severe or severe secondary mitral regurgitation. Patients in the trial were treated with either optimized medication treatment and the MitraClip or medication only.

Results from the trial indicated a 47% reduction in rehospitalization for patients in the MitraClip group over the control arm, with a two-year risk of death drop of 37% for MitraClip patients.

“Expanding the approval of this device to heart failure patients with significant secondary mitral regurgitation, who have failed to get symptom relief from other therapies, provides an important new treatment option. Careful evaluation by a team of specialists is essential to determining whether a particular patient is an appropriate candidate for this procedure,” FDA Center for Devices and Radiological Health Division of Cardiovascular Devices director Dr. Bram Zuckerman said in a press release.

Earlier this month, a review of FDA adverse event reports revealed that some Abbott implantable cardioverter defibrillator leads were much more likely to fail than those made by Boston Scientific or Medtronic to fail due to internal insulation breaches.

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