The U.S. FDA has granted breakthrough device designation for Bioventrix Inc.’s Revivent Tc Transcatheter Ventricular Enhancement System for heart failure following a heart attack. The system is designed to exclude scar tissue that has formed on the left ventricle in a procedure that is less invasive than current medical options and better than drug therapy, allowing healthy heart tissue to function more efficiently.

The left ventricle is the heart’s pumping chamber, and scarring can prevent it from contracting and providing the steady circulation of blood that the body needs. Current treatments for this type of heart failure include open-heart surgery, with its inherent risks and prolonged recovery, or medication, which masks heart failure symptoms but doesn’t address the root cause. Using the Revivent Tc system, micro-anchors are implanted that are designed to remodel the heart to a more normal size and shape, resulting in improved blood flow.

ALIVE IDE trial

San Ramon, Calif.-based Bioventrix is currently evaluating the Revivent Tc system in its pivotal ALIVE IDE trial to see if a less-invasive approach can improve heart function, symptoms and patients’ quality of life. The prospective, multicenter, dual-arm study is enrolling up to 120 patients at up to 20 U.S. centers with a primary endpoint analysis at one year. According to clinicaltrials.gov, the primary endpoints of the study are incidence of all cause death, mechanical support, emergent cardiac surgery, prolonged mechanical ventilation, renal failure and clinically important stroke compared with data from the STS database for surgical left-ventricular aneurysm repair at one month post-procedure; and rate of all cause death, mechanical support of reoperation from one through 12 months vs. untreated patients who remain on guideline-directed medical therapy.

“We anticipate the IDE trial to be done in about a year. It’s a relatively modest size trial of 80 treated and 40 control patients, and we’re well on our way to having the enrollment completed in about a year,” Ken Miller, Bioventrix’s CEO, told BioWorld MedTech. With a one-year follow-up, that puts Bioventrix on track for an FDA submission for Revivent Tc in the fall of 2021, he added.

Andrew Wechsler, emeritus professor of cardiothoracic surgery and Drexel University College of Medicine and the principal investigator of the ALIVE trial, told BioWorld MedTech that there have been no in-hospital mortalities among the few patients in the ALIVE trial who have achieve the one-year milestone. “Virtually every patient that had the procedure performed has improved, whereas virtually every patient in the [control] group … has either stayed the same or deteriorated,” he said.

CE mark and European study

The system earned the CE mark in late 2016 and is commercially available in Europe. Until recently, Bioventrix has had a relatively small sales force on the continent, but Miller said he’s been pleased with adoption. The company is focusing on markets where Revivent Tc has significant reimbursement, which is primarily in Germany. Bioventrix was also successful in getting CMS reimbursement for the product in the U.S., which should help with enrollment in the ALIVE trial.

A second randomized study of Revivent Tc is just getting underway in Europe. The prospective, multicenter, dual-arm REVIVE-HF trial, which will compare the system to guideline-directed medical therapy or drug treatment, plans to enroll 180 patients; 120 of whom will be treated with Revivent Tc. The main endpoint is improvement in heart failure symptoms based on a six-minute walking test. Bioventrix enrolled the first patient in October.

Miller said Bioventrix decided to do the REVIVE-HF trial on the recommendation of its medical advisory board. “We didn’t do a randomized trial in Europe for the CE mark,” he said, but the company realized that more data could help with physician adoption and establishing Revivent Tc as a standard or care.

“In the end, what we’re hopeful this does is we become the standard treatment for heart failure, for patients with ischemic cardiomyopathy and this leads to in the end getting on the European guidelines for the treatment of ischemic cardiomyopathy,” Miller said.

The REVIVE-HF trial will also be collecting data on functional mitral regurgitation, as doctors have been noting an improvement in patients treated with Revivent Tc, he added. If the data look good, Bioventrix may do a follow-up study for a functional regurgitation indication in the future.

Huge patient pool

Based on the million or so patients in the U.S. who have a heart attack each year, Miller estimates Revivent Tc could help about 183,000 of them. That includes people who don’t go to the hospital after a heart attack because they didn’t realize they had one and patients who still have scarring after stent implantation. “The worldwide market is two times that,” he said.

“These are patients that have pretty severe heart failure,” Andrew Wechsler said. The IDE requires Bioventrix to test Revivent Tc in patients with Class III and IV heart failure, people who experience symptoms – shortness of breath, fatigue, rapid heartbeat – with very low or moderate levels of activity, respectively. “From the European experience, we’ve actually had patients who have gone from Class III to Class I. Class I patients have no heart failure symptoms at all,” Wechsler said.

Both the U.S. and European studies are funded, but Bioventrix is looking to raise additional funds in the next few months to support additional uses for its product, such as the functional mitral regurgitation approach, as well as to develop a percutaneous version of Revivent Tc.

The company is also looking at a possible IPO in late 2020, Miller said. “I think we’re pretty well positioned to do that.”

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