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Direct Flow Medical Inc.

LimFlow taps Rose for CEO | Personnel Moves

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LimFlow taps ex-Direct Flow GM Rose as CEO LimFlow said this week that it tapped former Direct Flow Medical VP and GM Daniel Rose as its new chief executive, with former co-founder & CEO Timothy Lenihan transitioning to chief technology officer. LimFlow is developing a device to create percutaneous venous arterialization in the foot to treat end-stage critical limb […]

Recent TAVR approvals prompt changes to Direct Flow’s Salus trial

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Direct Flow Medical said today that recent FDA approvals for transcatheter aortic valve replacements prompted it to make changes to the Salus trial of its own TAVR entry. Salus, originally aimed at enrolling 1,262 patients, is now expected to enroll a little more than half that number, 648 subjects, the company said. Santa Rosa, Calif.-based […]

CORRECTION: Direct Flow Medical adds board members

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Correction, April 19, 2016: Due to a reporter’s error, this article originally stated that Direct Flow Medical raised a $31 million round, based on an amended regulatory filing. Direct Flow did not raise another $31 million; rather, a company spokesman said, the amended filing reflected the addition of new board members. We regret the error and […]

Direct Flow launches next-gen TAVI delivery system in the EU

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Direct Flow Medical today announced the European launch of its next-gen DirecTrack Delivery System designed for its Direct Flow transcatheter aortic valve system. The new system features improved ergonomics and functionality for greater control during the implantation procedure, the Santa Rosa, Calif.-based company said. “We’re pleased to provide physicians with this latest advance in TAVI procedural […]

Direct Flow debuts transcatheter mitral valve

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Direct Flow Medical said yesterday it premiered its transcatheter mitral valve, developed as part of its TMV development program. The debut was made at the 2nd annual Zurich Heart Team Mitral Valve meeting. The valve is designed to be repositionable and retrievable, and is built upon Direct Flow’s transcatheter aortic valve, the Santa Rosa, Calif.-based company […]

Bioventus taps ex-Medtronic CEO Hawkins for chairman | Personnel Moves

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Bioventus said it tapped former Medtronic (NYSE:MDT) and Immucor (NSDQ:BLUD) chief Bill Hawkins to be its new chairman, replacing Dan LeMaitre. Hawkins, who’s slated to appear at the upcoming DeviceTalks event in Raleigh, N.C., had the corner office at Medtronic from 2007 until 2011, when he took the helm at Immucor, where is he lead director. […]

AdvaMed taps LifeScience Alley’s Mandle to lead state medtech alliance | Personnel Moves

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AdvaMed said it named Shaye Mandle, CEO of Minnesota’s LifeScience Alley trade association, as chairman of its State Medical Technology Alliance. “The medical technology industry is a hallmark of U.S. innovation represented by a community of people dedicated to improving and saving lives. Now more than ever, medical technology has the opportunity to help deliver […]

TAVI: Direct Flow’s LeMaitre touts real-world data for next-gen heart valve

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Direct Flow Medical said last week that 1-year data from a post-market study of its transcatheter aortic valve implantation system showed a 95% rate of mild or no paravalvular regurgitation. The low rate of paravalvular leaks is of primary importance to the TAVI market, Direct Flow CEO Dan LeMaitre told MassDevice.com last week, as the procedures become more common […]

Reva Medical snags ex-MDT’er Groves for CEO | Personnel Moves

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Reva Medical (ASX:RVA) said last week it picked up ex-Medtronic (NYSE:MDT) divisional veep Regina Groves as its new CEO. Groves was vice president and GM of the atrial fibrillation solutions, cardiac rhythm and heart failure division at Medtronic. During her time there, she helped the company strategize a re-entry into the catheter-based atrial fibrillation ablation market, the […]