GlobalData analysts anticipate FDA approval for the JenaValve Trilogy TAVR device designed to treat aortic regurgitation (AR) this year. In a report, GlobalData says it expects the FDA to approve the transcatheter aortic valve replacement (TAVR) device by late 2025. TAVR currently serves as an option to treat aortic stenosis (AS). Expanding its indications to […]
JenaValve
JenaValve announces first case in new heart valve registry
JenaValve announced that it completed the first patient procedure for inclusion in a registry of its Trilogy transcatheter heart valve (THV) system. JENA-VAD, a prospective, multi-center, single-arm clinical registry nests within the ALIGN-AR study. It evaluates the ability of Trilogy to treat severe symptomatic aortic regurgitation (AR) safely and effectively in patients with a continuous […]
JenaValve to begin Trilogy heart valve trial
JenaValve announced today that it received the green light to begin a new randomized controlled trial for its Trilogy device. Irvine, California-based JenaValve can now start the ARTIST trial, slated for early next year. The company — set to be acquired by Edwards as part of a $1.2 billion double M&A swoop alongside Endotronix — […]
Edwards Lifesciences to spend $1.2B on two more M&A deals
Edwards Lifesciences is continuing its M&A run with two more major deals. The cardiac device company announced yesterday evening that it will spend $1.2 billion to acquire two companies: JenaValve Technology and Endotronix. The news came at the same time that the cardiac device company reported a second-quarter revenue miss and reduced TAVR guidance. As […]
JenaValve publishes positive data for its TAVR system
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 […]
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 […]
