V-Wave Interatrial Shunt System gets FDA breakthrough device status for HF

Israeli medical device company V-Wave has secured a breakthrough device designation from the US Food and Drug Administration (FDA) for its V-Wave Interatrial Shunt System for heart failure (HF).

The minimally invasive, implanted interatrial shunt is being investigated by the Israeli medical device company in a global, randomized, controlled, double-blinded investigational device exemption (IDE) trial called Relieve HF, featuring 500 patients. Relieve HF expands to reducing lung congestion symptoms in advanced heart failure.

Patients with advanced heart failure with preserved or lowered left ventricular ejection fraction who remain symptomatic despite the use of guideline-directed medical and device therapies are being enrolled by V-Wave in the Relieve HF trial.

V-Wave Interatrial Shunt System secures FDA breakthrough device designation for heart failure. Image courtesy of dream designs at FreeDigitalPhotos.net.

What is the V-Wave Interatrial Shunt System

According to the Israeli medical device company, the V-Wave Interatrial Shunt System is a miniature, biocompatible interatrial implant that regulates increased left atrial pressure (LAP). The implant is intended to eliminate episodes of elevated LAP to give relief from symptoms, reduce the need for hospitalization, improve exercise tolerance, enhance the quality of life, and may extend survival of the patients.

The V-Wave Interatrial Shunt System comprises an implant, which is permanently placed using its dedicated delivery catheter during a minimally invasive cardiac catheterization procedure The shunt is implanted via the fossa ovalis and straddles the interatrial septum.

Commenting on the FDA breakthrough device status for the V-Wave Interatrial Shunt System, William T. Abraham – V-Wave chief medical officer said: “This FDA Breakthrough Device Designation emphasizes the critical and unmet need for novel therapeutic devices for HF.

“More than 6 million people suffer from chronic heart failure in the US. HF remains a leading cause of acute hospitalization in the Medicare age group. Despite decades of advances in therapy, heart failure patients continue to deteriorate, enduring disabling symptoms, having a poor quality of life, diminished exercise tolerance, and a markedly reduced life expectancy.”

As per William Abraham, the V-Wave Interatrial Shunt System gives relief from excessive pressure in the left-side of the heart, as a result bringing down the chances of the build-up of fluid in the lungs, which is considered to be the most common cause for HF hospitalizations and exercise limitation.

Neal Eigler – V-Wave CEO, on the FDA breakthrough device status for the V-Wave Interatrial Shunt System, said: “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 USA. 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 CMS support for this program, makes our Breakthrough Designation a double-win for HF patients who need access to novel therapies as quickly as possible.”

For more regulatory updates on the V-Wave Interatrial Shunt System, keep following Pharma News Daily.

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V-Wave Interatrial Shunt System gets FDA breakthrough device status for HF added by pharmanewsdaily on August 25, 2019
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