JenaValve announced today that it published new results supporting the use of its transcatheter aortic valve replacement (TAVR) system. The company published results from its ALIGN-AR pivotal trial in The Lancet. The trial evaluates the Trilogy valve in high-risk patients with symptomatic moderate-to-severe or severe aortic regurgitation. JenaValve presented positive study results from ALIGN-AR last […]
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The biggest cardiovascular stories from TCT 2023
Every year, some of the biggest names in cardiovascular technologies come together in one place for TCT. This year’s 35th edition of the Transcatheter Cardiovascular Therapeutics annual scientific symposium was no different in San Francisco. Usual suspects like Medtronic and Abbott released data covering a range of products, while other big names like Edwards, GE […]
Slow and steady wins the race: JenaValve aims to offer new option for aortic regurgitation patients
The Munich-based startup JenaValve is a bit like the tortoise, with a slow and steady approach to transcatheter aortic valve replacement (TAVR) device development. At the Transcatheter Cardiovascular Therapeutics (TCT) conference today, Dr. Vinod Thourani, co-principal investigator of the ALIGN-AR study, jokingly compared the company’s approach to a “nice bottle of wine” that gets better […]
TAVR tech developer JenaValve adds J&J vet to its board
JenaValve Technology announced that it appointed cardiovascular industry veteran Shlomi Nachman to its board of directors. Nachman brings more than 25 years of experience to the transcatheter aortic valve replacement (TAVR) system maker’s board. He previously held senior operating roles at Johnson & Johnson. That included serving as company group chair of cardiovascular and specialty […]
JenaValve completes enrollment in TAVR trial
JenaValve announced today that it successfully completed patient enrollment in a trial evaluating its Trilogy heart valve system. Irvine, California-based JenaValve develops and manufactures differentiated transcatheter aortic valve replacement (TAVR) systems. It designed Trilogy for high surgical risk patients with symptomatic, severe aortic regurgitation (AR). JenaValve’s prospective, single-arm ALIGN-AR trial is operating under FDA investigational […]
JenaValve raises $100M Series C for TAVR tech
JenaValve Technology announced today that it completed the initial closing of a $100 million Series C financing round. Irvine, California-based JenaValve develops and manufactures differentiated transcatheter aortic valve replacement (TAVR) systems. The company intends to use proceeds from the financing to complete its FDA investigational device exemption (IDE) premarket approval (PMA) study to garner FDA […]
JenaValve appoints new chief commercial officer
JenaValve Technology has appointed Peter L. Spadaro Jr. to the newly created position of chief commercial 0fficer. Spadaro is an experienced cardiovascular sales and marketing executive who has held senior positions at industry giants including Medtronic, St. Jude Medical and most recently Syncardia. “Peter’s proven success in all aspects of launching and commercializing innovative structural […]
JenaValve raises $50m for TAVR tech
JenaValve Technology announced that it raised $50 million in equity financing as it develops and manufactures the JenaValve pericardial transcatheter aortic valve replacement (TAVR) system for treating aortic valve disease. Bain Capital Life Sciences led the funding round, while Andera Partners, Gimv, Legend Capital, NoMed Management, RMM, Valiance Life Sciences and VI Partners all participated, […]
JenaValve TAVR wins FDA breakthrough device designation
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 […]