JenaValve Technology said today that FDA has granted breakthrough device designation for its JenaValve Pericardial TAVR. The designation is for severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. It means that FDA will provide the Irvine, Calif.–based company with priority review and interactive communication regarding device development and clinical trial protocols. “We are […]
Dexcom adds COO to CFO Blackford’s title | Personnel Moves, September 19, 2019
Dexcom (NSDQ:DXCM) this week added the COO role to CFO Quentin Blackford’s title. Blackford is now in charge of Dexcom’s global supply chain, manufacturing operations and expansion into new markets, the San Diego-based company said. He’s been CFO of the continuous glucose monitor maker since 2017, when he left the chief finance spot at NuVasive (NSDQ:NUVA). […]
JenaValve adds $15m for TAVR device
JenaValve Technology said yesterday that it raised nearly $15 million for the transcatheter aortic valve replacement it’s developing. The Irvine, Calif.-based company makes the the Everdur valve and Coronatix delivery catheter to treat aortic stenosis and aortic regurgitation. In a regulatory filing, JenaValve said it pulled in $14.5 million in an equity round that began […]
JenaValve names Kilcoyne as CEO | Personnel Moves – January 15, 2019
JenaValve Technology said today that it named former ReVision Optics prez & CEO John Kilcoyne as its new chief executive officer, effective immediately, replacing Dr. Victoria Carr-Brendell, who has taken up an executive leadership position with Sonova Holding AG (SIX:SOON). Prior to his time at ReVision Optics, Kilcoyne served as prez & CEO at Micrus Endovascular where he […]
FDA OKs expanded JenaValve study
JenaValve Technology said today that the FDA approved the expansion of its investigational device exemption trials for the transcatheter aortic valve replacement it’s developing. The JenaValve system consists of the Everdur valve and Coronatix delivery catheter. The FDA decision expands the feasibility study from 20 extreme- or high-risk patients to 80 patients with either aortic stenosis or […]
JenaValve launches feasibility study of next-gen pericardial TAVR system
JenaValve Technology said today it launched an FDA investigational device exemption cleared early feasibility study of its next generation JenaValve pericardial transcatheter aortic valve replacement system. The newly launched trial will explore the use of the device as a minimally invasive treatment for patients with symptomatic, severe aortic stenosis and symptomatic aortic regurgitation in patients who […]
JenaValve launches CE Mark study of next-gen TAVR system
JenaValve Technology said this week it launched a new study of its next-generation pericardial transcatheter aortic valve replacement systems using its Coronatix transfemoral delivery catheter. In the newly launched trial, the Irvine, Calif.-based company will explore the use of the system as a treatment for severe aortic regurgitation in patients who are at high risk for […]
JenaValve raises $5m
JenaValve Technology has raised $4.9 million in a new round of debt financing, according to an SEC filing posted this week. The Irvine, Calif.-based company is one of several smaller players looking to enter the transcatheter aortic valve implant space as it challenges major players Edwards Lifesciences (NYSE:EW), Medtronic (NYSE:MDT), Abbott (NYSE:ABT) and Boston Scientific (NYSE:BSX). JenaValve has not yet […]
LimFlow taps Rose for CEO | Personnel Moves
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 […]
Stryker CFO Jellison retires, Boehnlein steps up | Personnel Moves
Stryker (NYSE:SYK) said yesterday that CFO and veep William Jellison is retiring, and will be replaced by former medsurg & neurotechnology group CFO Glenn Boehnlein. The Kalamazoo, Mich.-based company said Jellison, who’s been with Styker for 3 years, will pursue positions on boards and devote more time to his family. Jellison will stay on through […]
Ex-Insulet chief DeSisto out before he’s in at MannKind | Personnel Moves
MannKind Corporation said today it withdrew an offer that would have made ex-Insulet (NSDQ:PODD) CEO Duane DeSisto its new CEO only 19 days after officially posting its offer to DeSisto. The offer was withdrawn as objections were raised by DeSisto’s former employer Insulet, who said the new position would violate its non-competition agreement, which will be […]
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