Israeli InSeal nabs CE mark for TAVR closure device

InSeal Medical won a CE mark for its vascular closure device, used to seal large bores left by catheter-based procedures, such as transcatheter aortic valve replacement (TAVR).

The InClosure VCD comprises a self-expandable nitinol frame coated in a biodegradable membrane. The device seals puncture sites in blood vessels and is delivered with the same sheath used during the catheter-based procedure. It requires no preprocedure. It is situated across the puncture and leverages blood pressure to seal it against the vessel wall. The vascular closure procedure takes two minutes or less, according to an InSeal statement.

"The InClosure VCD significantly simplified large bore puncture closure which is still one of the last major challenges in TAVR,” said Dr. Ran Kornowski, director of the Department of Cardiology at the Rabin Medical Center in Petah Tikva, Israel and principal investigator of the InClosure clinical study, in the statement. “Based on our growing experience, the InClosure VCD allows for a smoother and safer TAVR procedure without pre-procedure manipulation of the vessel.”

According to Cardiac Interventions Today, most vascular complications from TAVR procedures occur when preclosure devices fail at the puncture site. While TAVR and EVAR (endovascular aneurysm repair) procedures themselves have improved in recent years, “suboptimal” closure technologies have limited their success, InSeal CEO Avi Penner said in the statement.

Caesarea, Israel-based InSeal Medical is backed by Waltham, MA’s Polaris Venture Partners. The company did not indicate a timeline for a regulatory filing in the U.S. Meanwhile, Dublin-based Vasorum got the FDA nod for its vascular device for arterial puncture closure.

- here's the statement

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