Edwards Lifesciences doubles down on Irish plant

Edwards LifesciencesEdwards Lifesciences (NYSE:EW)  reportedly plans to double its investment in a plant it’s building in Ireland that’s expected to add 600 jobs to the local economy.

Last year the Irvine, Calif.-based company said it planned to build a new, 170,000-square-foot facility in Limerick to manufacture delivery components for its transcatheter heart valves. At the time the project was slated to cost about $93.3 million (EU €80 million) and open in 2021.

Today Edwards said it will add another $93.3 million to the tab as it plans to build a larger plant but held to the 2021 timetable as it broke ground on the construction.

“Since we established operations in Ireland last year, we have appreciation for the excellent business environment to help develop our operations. We are also proud that we have had the opportunity to begin to engage in local community activities and initiate educational and professional opportunities for our employees,” chairman & CEO Michael Mussallem said, according to the Irish Times.

Edwards employs 50 workers in Shannon, the newspaper reported.

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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.

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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Neovasc claims win in German TMVR patent case against Edwards unit CardiAQ Valve

Edwards Lifesciences, CardiAQ Valve, NeovascNeovasc (NSDQ:NVCN) today claimed a win in its patent infringement war with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve Technologies, saying a German appeals court dismissed a case there.

In June 2017 the District Court in Munich ruled that CardiAQ Valve contributed to the creation of Neovasc’s Tiara transcatheter mitral valve replacement, awarding”co-entitlement” rights to the patent in Europe. Both sides appealed that ruling, in the course of which CardiAQ withdrew its total ownership claim but asserted partial ownership, Vancouver-based Neovasc said today.

Munich’s Higher Regional Court dismissed the remaining claims, finding that CardiAQ “had not contributed to the invention of the Tiara” and ruling “Neovasc to be the rightful inventor and owner of all rights to the disputed Tiara European patent application,” according to Neovasc.

“We are pleased that after full consideration of the evidence, the German courts have now recognized that CardiAQ made no contribution to the invention or development of the Tiara,” CEO Fred Colen said in prepared remarks. “With this decision, which we strongly believe would be confirmed, even if appealed to and accepted as a case by the German Supreme Court, Neovasc is free to pursue its European patent application and has the sole right to commercialize the Tiara in Europe and help treat patients suffering from debilitating mitral valve disease. We will continue to vigorously defend our intellectual property against any attempts by third parties to infringe on these rights.”

The German case is only one front in the companies’ TMVR war. In the U.S., a jury in May 2016 awarded $70 million to CardiAQ after finding that Neovasc misappropriated trade secrets in developing Tiara. A federal judge in Massachusetts added $21 million in enhanced damages to the decision that November; in January 2017 the Boston court added another $21 million to the judgment.

Edwards, which inherited the beef when it acquired CardiAQ Valve for $400 million in August 2014, did not immediately reply to a request for comment.

Earlier this month Neovasc inked an exchange deal for the last of the warrants it issued as part of a $65 million funding round to cover the litigation damages.

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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 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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Neovasc advances warrant exchange from CardiAQ case


Neovasc (NSDQ:NVCN) said today that it inked an exchange deal for the last of the warrants it issued as part of a $65 million funding round to cover the damages from litigation with Edwards Lifesciences (NYSE:EW) subsidiary CardiAQ Valve.

The Vancouver-based replacement heart valve developer said it plans to exchange the Series A and Series E warrants it issued in November 2017 to cover the $42 million balance from its loss in the CardiAQ lawsuit. The deals call for Neovasc to issue more than 496,000 shares in exchange for nearly 58.4 million warrants, which works out to 0.0085 shares per warrant.

“We are delighted to be able to continue our stepwise approach to clearing the remaining elements of the 2017 financings,” CEO Fred Colen said in prepared remarks.

A jury in May 2016 awarded $70 million to CardiAQ after finding that Neovasc misappropriated trade secrets in developing its Tiara transcatheter mitral valve replacement device (Edwards inherited the lawsuit when it acquired CardiAQ Valve for $400 million in August 2014). A federal judge in Massachusetts added $21 million in enhanced damages to the decision in November 2016.

Last month Neovasc priced a $5 million offering, saying it plans to use the $4.1 million in net proceeds for continued development of its Reducer device and Tiara valve, and settled a spat with Micro Interventional Devices for $3 million.

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Edwards Lifesciences gets in on Corvia, Mitralign

Edwards LifesciencesEdwards Lifesciences (NYSE:EW) said today that it made a pair of strategic bets on the structural heart space, paying $35 million for the right to acquire Corvia Medical and paying an unspecified amount for some of mitral valve repair device maker Mitralign‘s assets.

Tewksbury, Mass.-based Corvia is developing an interatrial shunt to treat heart failure by creating a small opening between the left and right atria to lower blood pressure in the left atrium and lungs. The device has CE Mark approval in the European Union and a pivotal U.S trial aimed at winning a nod from the FDA is under way, Edwards said.

The Irvine, Calif.-based company also said it bought “certain” Mitralign assets, including intellectual property and associated clinical and regulatory experience. Mitralign, also based in Tewksbury, is developing an annuloplasty system for treating functional mitral and tricuspid regurgitation.

Edwards said the transactions are not expected to affect its financial outlook for 2019.

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Study of Boston Scientific’s Lotus, Medtronic’s CoreValve shows similar outcomes at 2 years

Medtronic, Boston Scientific

Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products.

The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system.

Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices.

Patients, treated between September 22, 2014 and December 24, 2015, were randomized two to one to receive the Lotus valve or CoreValve system at 55 centers spanning North America, Australia and Europe, according to study results.

Main outcomes being explored by researchers were all-cause mortality and all-cause mortality or disabling stroke at two years. Other factors examined included overall stroke, disabling stroke, repeat procedures, rehospitalization, valve thrombosis and pacemaker implantation.

At two years, results indicated similar rates of all-cause mortality, mortality and disabling stroke between the competing valve devices, according to the study results.

All-cause death was reported at 21.3% with the Lotus valve, versus 22.5% with the CoreValve, while rates of all-cause mortality or disabling stroke were 22.8% with the Lotus and 27% with the CoreValve. Rates of overall stroke were 8.4% with Boston Scientific’s Lotus offering, and 11.4% with Medtronic’s CoreValve.

Disabling stroke rates were higher for patients treated with the CoreValve at 8.6% versus a lower 4.7% with the Lotus device, while more Lotus patients were likely to receive pacemakers than those treated with the CoreValve at 41.7% versus 26.1%, according to the results.

“Disabling stroke, functional class, valve migration, and PVL favored the Lotus arm whereas valve hemodynamics, thrombosis, and new pacemaker implantation favored the CoreValve arm,” research investigators concluded.

Patients in the trial will be followed out to five-years post procedure, investigators said.

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Swiss heart valve dev Novostia raises $7m


Swiss cardiovascular device developer Novostia said today it raised $6.5 million (CHF 6.5 million) to support its novel heart valve device.

The Neuchâtel-based company said that the valve, which will be designed for use as both an aortic and mitral valve replacement, is designed from the company’s proprietary high-performance biocompatible polymer.

Novostia said that the design, as well as the materials that make up the valve, eliminate the need for lifelong anticoagulant medication use or future replacements as well as the elimination of clicking noises often associated with the valves.

“Our technology should significantly improve the quality of life of people bearing a heart valve prosthesis, especially kids and young patients, while reducing overall healthcare costs. We appreciate the trust and support of our investors and look forward to bringing this long-awaited innovation to the patients and the physicians,” CEO Geoffroy Lapeyre said in a press release.

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