The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning Oct. 29. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016.
After stents took center stage Day 1, with a raft of studies covering the latest on the bioresorbable front, transcatheter valve replacements were the focus on Day 2 at the Transcatheter Cardiovascular Therapies conference:
FDA OKs pivotal trial for Medtronic’s Harmony pulmonary valve replacement on positive feasibility study
Medtronic (NYSE:MDT) said today that the FDA approved an investigational device exemption for a pivotal trial of its Harmony transcatheter pulmonary valve replacement based on positive 1-year feasibility study results presented at TCT 2016.
The 18-patient study showed statistically significant improvements in hemodynamics, including RV end diastolic volume from 280.4 ± 74.0ml pre-implant to 195.1 ± 57.9, Medtronic said. Mean gradients were consistent and stable and there were no clinically significant paravalvular leaks, according to the company.
“These outcomes are promising indicators that this technology can help patients who experience severe pulmonary regurgitation after repair of complex congenital heart disease,” Dr. Lee Benson, of the University of Toronto, said in prepared remarks. “We look forward to further evaluating the clinical performance of the Harmony TPV in future studies and providing this growing patient population with a less invasive option to address pulmonary regurgitation, which can be adapted to different outflow tract morphologies.”
“We are excited to further study this device with the initiation of our Harmony TPV Pivotal IDE study, and ultimately, if the data are positive, enable more patients to have access to a less invasive non-surgical option following approval,” added Medtronic vice president Rhonda Robb. “Together with leading physicians, we look forward to expanding our heart valve therapy portfolio with innovative products that address the unmet lifetime needs of CHD patients.”