Edwards Preparing Prima Plus Stentless Heart Valve Postmarket Study
This article was originally published in The Gray Sheet
Executive Summary
Edwards Lifesciences is preparing for a postmarket study to evaluate long-term effectiveness of the XenoLogiX anticalcification treatment used with its Prima Plus stentless porcine tissue heart valve following FDA approval of the valve Feb. 27.
You may also be interested in...
Medtronic launching Freestyle stentless porcine heart valve at a premium to St. Jude's Toronto SPV.
MEDTRONIC PRICING FREESTYLE VALVE AT PREMIUM TO ST. JUDE's TORONTO SPV, indicating a belief that the "advanced tissue technology" gives Medtronic an edge over its only competitor in the U.S. stentless porcine heart valve market. Premarket approval applications for the Medtronic and St. Jude stentless porcine heart valves cleared FDA on Nov. 25 and Nov. 24, respectively.
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.
How Ochre Bio Bagged Boehringer For Its RNA-Based Regenerative MASH Therapies
UK-based Ochre Bio has signed its first major deal with Boehringer Ingelheim. Scrip talked to its co-founder and CEO, Jack O’Meara, about its human tissue-based drug discovery platform, its resulting RNA platform for liver disease and how the fledgling drug company's early work mirrored that seen in diagnostics.