Neovasc wins FDA nod to expand Tiara TMVR trial

Neovasc (NSDQ:NVCN) said today that it won approval from the FDA to expand a clinical trial of its Tiara transcatheter mitral valve implant to include a larger valve size.

Vancouver-based Neovasc said the federal safety watchdog approved the use of the 40mm Tiara device in its 30-patient Tiara-I early feasibility study, which was already approved for the 35mm valve. Neovasc has also said it’s developing a 45mm valve size.

“We believe the addition of the 40mm size is an important step in the Tiara program and should significantly increase the number of patients eligible for treatment,” CEO Alexei Marko said in prepared remarks. “With both the 35mm and 40mm sizes now available, we are continuing development activities to bring additional sizes into clinical use.”

As of Nov. 9, 2015, 11 patients had been implanted with Tiara in early feasibility and compassionate use cases, Neovasc said at the time.

The company is facing accusations of trade theft from rival CardiAQ Valve, which was acquired by replacement heart valve giant Edwards Lifesciences (NYSE:EW) last year.

The post Neovasc wins FDA nod to expand Tiara TMVR trial appeared first on MassDevice.

from MassDevice http://ift.tt/1mRgElq