Cerus lands additional $15m in government funding

Cerus (NSDQ:CERS) landed a $15 million amendment to its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and Development Authority, bringing the total potential value of its deal to $201 million.

The expanded agreement is designed to support additional clinical trials of the company’s Intercept blood transfusion technology.

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

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CoreMedic launches first-in-human study of ChordArt mitral repair device

German medtech developer CoreMedic this week announced the launch of a first-in-man trial of its ChordArt mitral valve repair device, touting the trial as the first of its kind to treat patients with ruptured or elongated mitral chords.

The company’s ChordArt implant is designed to replace ruptured or elongated mitral chordae and to re-establish the connection of the valve leaflets with the papillary muscle to restore functionality. In the trial, researchers will explore the use of the system in up to 40 patients at six European centers, CoreMedic said.

“The first clinical use of ChordArt is a major milestone in our path towards developing the best in class transfemoral mitral valve chordal repair system,” CEO Thomas Bauer said in a prepared release.

“In 2017 we invested in CoreMedic to advance the development of ChordArt. We look forward to the results of clinical trials that will validate the applications of this breakthrough device,” SHS managing partner Hubertus Leonhardt said in a prepared statement.

The first patient in the trial has already been treated by Dr. Kęstutis Ručinskas at Lithuania’s Vilnius University Hospital. The patient has reportedly recovered “very well” from the intervention and has shown no signs of complications at a 30-day follow-up.

“Using the ChordArt reduced the invasiveness and duration of the procedure by repairing the valve in a fast, precise and safe way. This allowed the Heart Team to focus on the procedure and timing rather than manually placing the artificial chords to resolve the mitral insufficiency. Thanks to the ease of the ChordArt deployment technique, this was the fastest mitral valve chordal repair I have ever witnessed,” Dr. Alberto Weber of Zurich, Switzerland, who proctored the procedure, said in a press release.

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Boston Scientific touts safety, effectiveness in Rhythmia mapping study

Boston Scientific‘s (NYSE:BSX) Rhythmia mapping system and catheter was found to be safe and effective in procedures to treat arrhythmias, according to a Healio summary of a newly released study from the company.

Researchers in the study examined 572 patients, with 519 patients undergoing procedures with the Rhythmia system and IntellaMap Orion catheter, according to the report. A total of 504 patients had a complete mapping procedure and were followed for one month post-procedure.

Findings from the study were presented at the EHRA 2018 meeting, according to Healio.

The primary endpoint of the trial was acute procedural success as defined by assessing the ability to map an arrhythmia or its substrate, completion of ablation applications and arrhythmia termination where applicable, with validation through appropriate techniques, according to the report.

Investigators reported that 83.3% of patients treated had successful procedures confirmed by arrhythmia-specific validation techniques. They also reported 96% success rate in treating cavotricuspid isthmus-dependent atrial flutter, 83% for non-cavotricuspid isthmus-dependent macro re-entrance atrial tachycardia, 81% for non-macro re-entrance atrial tachycardia, 80% for AF, 64% for ventricular arrhythmias and 94% for other arrhythmias, Healio reported.

Median time or map acquisition during procedures was 29 minutes and 41 seconds, with 73% of patients who had maps collected requiring additional ablation after validation mapping, according to the report.

A total of 61 adverse events in 49 patients were document, with 4% being ablation-related complications and 0.6% related to the mapping catheter, Healio reports.

“In most patients with substrate-based cardiac arrhythmias, electrophysiologic information about the properties of the substrate is key for the development of an appropriate treatment strategy. Currently, substrate-based arrhythmias constitute approximately 75% of all indications in interventional electrophysiology. This technology focuses on the key challenges in interventional and curative treatment of cardiac arrhythmias. However, until the True-HD study was completed, large-scale, multicenter data with more solid information on the mapping ability and properties, safety aspect and outcome, workflow and process effects had not been available,” Dr. Gerhard Hindricks of Germany’s Leipzig University Heart Center said, according to the report.

Yesterday, Boston Scientific released data from the Ranger SFA trial that showed that treatment with its drug-coated balloon succeeded in the femoropopliteal segment after one year and resulted in greater rates of patency, with fewer interventions, compared to standard balloon angioplasty.

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Medtronic launches study of drug-eluting stent as treatment for bifurcation lesions

Medtronic (NYSE:MDT) today launched a study to evaluate the safety and efficacy of its Resolute Onyx drug-eluting stent for the treatment of bifurcation lesions in patients with coronary artery disease.

The medtech giant said that bifurcation lesions make up nearly 20% of all percutaneous coronary interventions. The assessment of DES tech in this patient group is part of Medtronic’s post-approval study of its Resolute Onyx device.

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

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HRS 2018 Roundup: Device-related blood clots with Boston Scientific’s Watchman implant

Data from a study of device-related blood clots and the Watchman cardiac implant made by Boston Scientific (NYSE:BSX), presented today at the annual meeting of the Heart Rhythm Society in Boston, indicate the need for aggressive management of patients at risk for device-related thrombosis.

There were 74 incidences of DRT in 65 of the 1,739 Watchman patients examined in the study, or 3.7%; eight of those patients had multiple DRTs and two experienced embolic events (0.45%). There was no significant difference in mortality between patients with DRT and those without, according to the study.

Lead author Dr. Vivek Reddy, of New York’s Mt. Sinai Hospital, told MassDevice.com that the overall incidence of DRT for Watchman in the study was 3.7% using the FDA-approved strategy for anti-coagulation drugs. The surprise, Reddy told us, was the high rate of ischemic stroke in the DRT population.

“It’s surprising, not from a patho-physiological conceptual perspective, but it’s surprising because when we looked at this very early in Protect AF, again a small number of the patients in a relatively small follow-up, we did see that the subsequent stroke rate was a little bit higher, but certainly nothing like this,” he said. “We knew it was important, we knew that you had to do surveillance, we knew that if you see it you need to treat it, but we didn’t expect it to be this high.

“I think what this tells me, is that one has to be aggressive about dealing with device-related thrombus,” Reddy said, noting that it’s less clear how to proceed over the long term than in acute cases.

“It’s pretty clear how you treat it acutely – you give anticoagulation and let it dissolve,” he explained. “What’s less clear, though, is what do you do long-term after that. I think that what I would recommend, not that we have definitive data on this yet, but what I would recommend is aggressive surveillance in those patients who had device-related thrombus. I would recommend that some of them will probably require longer-term anticoagulation. That’s my guess.

“These data I don’t think take away from the argument that Watchman is a reasonable strategy. It doesn’t add or detract from the previous data. What it does do though is, I think it hones in and says when you have this you have to treat those patients aggressively,” Reddy told us.

Next >>

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7 medtech stories we missed this week: May 11, 2018

[Image from unsplash.com]

From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning.

1. ReShape submits for Health Canada approval of ReShape balloon

ReShape announced in a May 10 press release that it has submitted an application to the Medical Devices Bureau of the Therapeutic Products Directorate in Canada to amend its existing Canadian medical device license to include distribution of the ReShape Balloon and its accessories. The ReShape Balloon is FDA approved and is a non-surgical weight loss procedure that uses advanced balloon technology that takes up room in the stomach to help people with high body mass index.

2. FDA clears BrainsWay’s deep TMS stimulator for depression

BrainsWay has received FDA 510(k) clearance for its new stimulator that is used in its Deep Transcranial Magnetic Stimulation (Deep TMS) system to treat major depressive disorder, according to a May 6 press release. The stimulator enhances the Deep TMS system and features BrainWay’s H-Coil helmet to reach deeper and larger surface areas of the brain than standard TMS treatments.

3. Innovative Health wins FDA nod for Xtra DX ultrasound cath

Innovative Health announced in a May 7 press release that it has received FDA clearance to reprocess its ViewFlex Xtra Diagnostic Ultrasound Catheter. The clearance allows the company to develop a full suite of catheters. ViewFlex catheters are used in EP labs to help visualize cardiac anatomy and physiology. The clearance will add more diagnostic, EP-specific device, ultrasound and mapping catheters the company’s current line of products.

4. QT Medical wins FDA nod for home-use ECG

QT Medical has received FDA 510(k) clearance for its home-use 12-lead ECG device, according to a May 4 press release. The device can be used at home by a patient to perform a hospital-grade ECG scan of their heart that is sent through a cloud-based system to a physician for evaluation. When patients are experiencing symptoms following coronary artery bypass surgery or placement of a coronary stent, they can use the QT ECG to connect with their cardiologists in real time where the doctor can diagnose and prevent costly emergency room visits.

5. FDA clears PeraHealth’s clinical surveillance tech

PeraHealth announced in a May 3 press release that it has received FDA 510(k) clearance for its clinical surveillance technology, PeraTrend. PeraTrend is powered by the Rothman Index, which is a measure of a patient’s condition for healthcare providers. It allows hospitals to leverage data within an existing electronic health record to quantify and visualize patient deterioration, risk and improvement in real time.

6. Exact Imaging wins FDA nod for FusionVu

Exact Imaging has received FDA 510(l) clearance for its FusionVu application, according to a May 3 press release. The FusionVu is part of the ExactVu micro-ultrasound system that allows urologists to perform cognitive fusion through Cognitive Assist or micro-ultrasound/MR fusion on the ExactVu high-resolution platform.

7. Conavi wins FDA nod for Novasight hybrid system

Conavi announced in a May 1 press release that it has received FDA 510(k) clearance for its Novasight Hybrid System. The System allows for simultaneous imaging of coronary arteries with intravascular ultrasound and optical coherence tomography. Both imaging methods are used by interventional cardiologists to image coronary anatomy during angioplasty and stunting procedures.

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HRS 2018: Study questions benefit of ablation over drug therapy for atrial fibrillation

The annual meeting of the Heart Rhythm Society got under way in earnest today in Boston with a quintet of late-breaking clinical results from studies that sought creative ways to answer some of cardiology’s most pressing problems.

“Most of these studies have not been the conventional head-to-head clinical trials with the usual bopring study structure. What we’ve seen today are some really innovative, really rigorous, quite novel, innovative ways of approaching studies,” noted Dr. Robert Sheldon, of the University of Calgary, in presenting data from his own trial comparing pacemakers and implantable cardiac monitors.

Long-awaited data released today from a large clinical trial comparing catheter ablation with drug therapy in treating atrial fibrillation showed no significant benefit for ablation, according to Dr. Douglas Packer, who presented the findings today at the annual meeting of the Heart Rhythm Society in Boston.

The 2,204-patient trial, sponsored by the National Institutes of Health and industry players Medtronic (NYSE:MDT), Boston Scientific (NYSE:BSX), Abbott (NYSE:ABT) and Johnson & Johnson (NYSE:JNJ) unit BioSense Webster, focused on a primary composite endpoint of total mortality, disabling stroke, bleeding and cardiac arrest. When considering all patients as randomized, Packer said, the researchers saw no difference between the control and treatment arms.

Researchers included patients who “warranted therapy” due to their under-treated paroxysmal or persistent atrial fibrillation and followed them, on average, for 48 months. The patients were randomized 1:1 to either ablation or medical therapy with rate or rhythm control drugs.

“I would like to thank the Fix HF C5 study investigators and the Impulse Dynamics’ team for completing this important study with its very encouraging results,” CEO Dr. Simos Kedikoglou said in prepared remarks. “We anticipate submission of the final PMA module to the U.S. FDA in June 2018.”

“The study reinforced ablation as a preferred therapy option for treating patients with symptomatic atrial fibrillation (AF) while showing a distinct reduction in mortality for patients receiving ablation therapy. The results are encouraging and should help more patients with AF be evaluated for ablation as a front-line therapy option,” noted Dr. Srijoy Mahapatra, medical director for electrophysiology at Abbott.

Packer pointed out that there were concerns in the sub-group analyses, mainly that a number of patients crossed over between the treatment and control arms. Many patients who were randomized to ablation did not actually receive ablation therapy, due to patient preference or cost, he noted.

That said, for those that received ablation therapy, there was a benefit in relative risk reduction, Packer said.

“You can’t get a benefit from the therapy if you don’t get the therapy,” he explained.

There was a 47% drop in the relative risk of recurrent atrial fibrillation for patients who received ablation compared to those who received drug therapy, he said.

The takeaway, according to Packer, is that ablation may be right for patients in particular sub-groups – like those who are under the age of 65 or have a history of heart failure – but it would be wrong to assume that all atrial fibrillation patients should be ablated based on the data from Cabana.

“That’s simply not the case,” he said. “We do think that ablation is an acceptable treatment strategy for treating atrial fibrillation with low adverse events rates, which surprised us quite a bit, in higher-risk patients.”

“I think the bulk of data now presented suggest at the very least [ablation] is equivalent, and in many cases probably superior to drug therapy. I think patients should be allowed to have it as first-line treatment by people who know what they’re doing,” Dr. Eric Prystowsky said at HRS, commenting on the study.

“I would recommend for everyone here to avoid the usual ‘trial creep’ and that means you have to read the paper when it comes to look carefully at who was in the trial,” he added, pointing out that the results are largely dependent on patient sub-groups.

Parker also said that they will soon publish analyses relating to quality of life measures in patients who were ablated.

“Sometimes there are patients who are so burdened by their atrial fibrillation that they don’t care about mortality. They care about quality of life,” he said.

“Clinical trials give you data and they give you knowledge, but they don’t give you wisdom or judgement,” added Dr. Robert Sheldon, of the University of Calgary. “I think that Cabana should increase your thinking and change your thinking, but what it does for each particular patient depends upon the patient.”

Asked whether the Cabana results will affect how she advises patients, Dr. Christine Albert of Boston’s Brigham and Women’s Hospital said she wants to review the data in detail.

“I want to see the paper,” Albert said.

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Investors win class certification in lawsuit against Abbott’s Thoratec

A group of Thoratec shareholders this week won a class certification in a revived suit claiming that Thoratec, now owned by Abbott (NYSE:ABT), and some of its officers hid facts about its HeartMate II heart pump’s rate of thrombosis that would have negatively affected share prices, thereby misleading investors.

Investor Bradley Cooper originally brought the suit against the company in January 2014, on behalf of anyone who bought stock between April 29, 2010, and Nov. 27, 2013. Plaintiffs in the case argued that the company failed to warn investors about a blood clot problem with its HeartMate II implant implicated in a Class I recall.

In 2013, the FDA said an improperly connected component in the implant may result in deformation or tearing of the device’s outflow conduit, putting the patient at risk of serious injury or death. A year before that, a study published in the New England Journal of Medicine showed a sharp increase in the rate of blood clots with the HeartMate II LVAD.

The Pleasanton, Calif.-based device maker issued a correction notice in February 2012, warning physicians that a small portion of the HeartMate II devices’ sealed outflow graft bend reliefs, designed to prevent a connector between the pump and the aorta from kinking, were not properly connected.

“Thoratec hid from its investors its own internal data confirming such reports and the related financial risk, and did not correct its prior disclosures. […] Thoratec did not disclose the extent of the impact that the reported increases had on HeartMate II’s commercial viability until August 6, 2014, causing its stock to drop some twenty-five percent,” according to court documents.

The suit was revived last October by a Ninth Circuit panel which decided it was a mistake that a lower court dismissed the case, and that investors had sufficient grounds for their claims that the company misled them.

The case now includes both Bradley Cooper and Todd Labak as plaintiffs, who both purchased shares in July and August 2013. Plaintiffs in the case were found to meet the appropriate rules for class certification, US District Judge Claudia Wilken ruled this week, according to court documents.

Abbott acquired Thoratec when it bought St. Jude Medical last year. Last May, Abbott recalled nearly 29,000 controllers for the HeartMate II implantable heart pump after 26 patients died trying to change out the controllers on their own.

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Acutus Medical launches AcQMap cardiac mapping tech in US

Acutus Medical said today it launched the AcQMap high-resolution imaging & mapping system and the 3D mapping catheter that goes by the same name, touting that the system had been used in its first commercial procedures.

The Carlsbad, Calif.-based company said that AcQMap system is designed to detect and display standard voltage-based and higher resolution charge-source maps, and is able to generate real-time, 3D images of the heart chamber using ultrasound.

“Enabling physicians to see complex, irregular arrhythmias in real-time should provide important new insights and enable truly personalized and individualized ablation therapy planning.  We hope that this unique capability, combined with the ability to quickly re-map after each ablation, will lead the way to further improvements in clinical outcomes for patients suffering from complex arrhythmias. Together with institutions across the country, we hope to transform the lives of people suffering from complex arrhythmias through our innovative technology and are pleased that U.S. patients now have access to AcQMap,” prez & CEO Vince Burgess said in a press release.

Acutus Medical said that it has also launched a clinical study of the device exploring its use during atrial fibrillation retreatment ablation procedures.

Last October, Acutus Medical said that it won 510(k) clearance from the FDA for its AcQMap system. The system won CE Mark approval in the European Union in May 2016.

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All heart: A Google executive’s real-world experience with medtech

Heidi Dohse, senior program manager at Google

After hearing the story of her 10 cardiac surgeries and seven pacemakers, you could be forgiven for thinking that Heidi Dohse has a weak heart. But the Google executive, endurance cyclist and, now, inspirational speaker she may have a stronger heart than most people on the planet.

Dohse, a senior program manager at Google and upcoming keynote speaker at DeviceTalks Minnesota, was 18 when an EKG before a routine knee surgery to clean out scar tissue, which had built up during her days as a competitive skier and professional windsurfer, uncovered a rare and potentially deadly arrhythmia.

“It turns out 270 [beats per minute] is not normal,” Dohse told MassDevice.com recently.

That routine EKG visit turned into a 30-day stay at University of California, San Francisco’s cardiac care unit, she told us, where she became essentially a research subject as doctors tried to decipher a rare arrhythmia that caused her heart rate to fluctuate from 270 BPM to 12 BPM.

Eventually, Dohse was asked if she wanted to participate in an experimental AV node ablation surgery, performed by Dr. Melvin Scheinman. It was then that she was implanted with the first of her seven pacemakers.

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

And come to DeviceTalks Minnesota on June 4–5 to hear the rest of Heidi’s incredible story, and find out how she’s working to enable the patient’s voice.

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