JenaValve Technology Inc., developer and manufacturer of differentiated pericardial transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, has appointed Peter L. Spadaro Jr. to the newly created position of chief commercial officer. Spadaro is a highly accomplished cardiovascular sales and marketing executive who has held senior positions at global industry leaders including Medtronic plc, St. Jude Medical Inc., and most recently Syncardia.
 
“Peter’s proven success in all aspects of launching and commercializing innovative structural heart devices in the U.S. and internationally clearly makes him the ideal professional to lead this key function at JenaValve as we progress toward commercialization of our technology,” said JenaValve CEO John Kilcoyne. “He brings us unrivaled industry experience including a stellar track record in commercial planning and tactical execution. Peter has the ability to identify and capitalize on market opportunities and brings to JenaValve long established relationships with cardiovascular key opinion leaders and practitioners worldwide.”
 
“I am excited to undertake the challenge of building and overseeing a commercial organization to launch a much-needed minimally invasive and innovative solution for the treatment of aortic regurgitation,” said Spadaro. “Importantly, I share the passion and commitment of the JenaValve team for excellence in developing this game-changing technology and working closely with physicians to improve the lives of patients who suffer from the life-threatening challenge.”
 
JenaValve has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), which allows for priority review of the ALIGN Clinical Trial for the treatment of symptomatic, severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. JenaValve’s TAVR System is differentiated in that no other transcatheter valve device is currently available for patients suffering from severe aortic regurgitation who are at high risk for open heart surgery in this multi-billion-dollar market opportunity. Following completion of the HDE portion of the trial, patient enrollment is expected to continue in support of a premarket approval (PMA) application to the FDA. The company is also pursuing CE mark approval for both aortic stenosis and aortic regurgitation.
 
The JenaValve Pericardial TAVR System consists of a Pericardial Aortic Valve and Transfemoral Delivery System. The bioprosthesis comprises a self-expanding nitinol stent with a porcine pericardial valve manufactured using tissue processing techniques. The transfemoral delivery catheter is designed to deliver the bioprosthesis using a simple stepped approach with anatomic positioning over the native valve. The System is available in three sizes intended for aortic annulus diameters from 21mm to 27mm.
 
The JenaValve Pericardial TAVR System is an investigational device in the United States and internationally.
 
JenaValve is backed by Bain Capital Life Sciences as well as European and Asian investors, including Andera Partners (formerly Edmond de Rothschild Investment Partners), Gimv (Euronext: GIMB), Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners.