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August Is Hot with New FDA Breakthrough Device Designations

Caesarea, Israel-based V-Wave has received breakthrough device designation for its Interatrial Shunt for heart failure. It is one of several companies this month to receive the designation, which is granted to devices that have the potential to offer a more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases.

V-Wave's interatrial shunt

Courtesy of V-Wave

V-Wave is joining the growing list of companies that have been granted breakthrough device designation by FDA this month. The Caesarea, Israel-based company gained the designation for its interatrial shunt for heart failure.

Miniature and minimally invasive, the interatrial shunt relieves increased left atrial pressure, which in turn, decreases fluid build-up in the lungs.

“The interatrial shunt allows a small amount of blood volume from the left side of the heart to flow into the right side of the heart,” Murtaza Mogri, PhD Director, Business Development & Market Access V-Wave, told MD+DI.

In a release, “V-Wave CEO Neal Eigler, MD, added, "We are thrilled to be able to work even more closely with the FDA to accelerate the introduction of potentially clinically impactful therapies in the U.S. This breakthrough designation provides V-Wave with additional options for FDA communication that will facilitate collaboration, as well as a prioritized review of submissions and marketing applications. The potential for early Centers for Medicare and Medicaid Services support for this program, makes our Breakthrough Designation a double-win for heart failure patients who need access to novel therapies as quickly as possible."

Currently, the interatrial shunt is being evaluated in a global, randomized, controlled, double-blinded, 500 patient pivotal IDE trial called RELIEVE-HF. The study is enrolling advanced HF patients with preserved or reduced left ventricular ejection fraction who remain symptomatic despite the use of guideline-directed medical and device therapies. The estimated study completion date is on May 1, 2025, according to www.clinicaltrials.gov.

“We launched our pivotal trial in September of last year,” Mogri said. “We had our first patient at Ohio University.

August has been a robust month for breakthrough device designations. Typically, these designations are granted to devices that have the potential to offer a "more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases." The program also aims to provide patients and health care providers with more timely access to medical devices "by speeding up their development, assessment and review," including prioritized review all the way through market approval.

Last week, Concept Medical was granted breakthrough device designation from FDA for the MagicTouch PTA, a Sirolimus drug-coated balloon catheter, for the treatment of Peripheral Artery Disease in Below-the-Knee.

Shortly after Concept Medical made its announcement, Perfuze, another medtech company, said it had been granted breakthrough device designation by the FDA for the Millipede Clot Ingestion System technology.

And earlier this month, B. Braun Intervention Systems said it was granted breakthrough device designation for the SeQuent Please ReX drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis.

 

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