Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

Impella Safety Update: Data Supports Pump For Qualified Patients

Updated data from a postmarket study of Abiomed’s Impella RP right-heart pump further supports the device’s safety for a specific patient population.

Quality, Safety, MDSAP A Focus For Medtech In New USMCA Trade Agreement

The new US-Mexico-Canada (USMCA) trade agreement includes language on enhancing regulatory compatibility between the three countries by recognizing quality systems audits performed under the Medical Device Single Audit Program (MDSAP). It also stipulates that each trading partner “consider its resources and technical capacity” in ensuring the safety, effectiveness and quality of devices – and more. Medtech industry advocacy group AdvaMed is praising the deal, reached by the three countries on 10 December.

UsernamePublicRestriction

Register

MT014557

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel