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

CorCap controversy headed for panel

This article was originally published in The Gray Sheet

Executive Summary

Acorn Cardiovascular's CorCap cardiac support device has the dubious distinction of being one of two devices referred to FDA's Medical Devices Dispute Resolution Panel in 2006 after three years of inactivity from the independent review body. The panel will convene Dec. 15 to review the science behind the company's PMA application for the polyester mesh wrap, intended to provide ventricular support in patients with symptomatic heart failure despite optimal medical management, Acorn's Oct. 17 release indicates. FDA's Circulatory System Devices Panel voted 9-4 against approval in June 2005 (1"The Gray Sheet" June 27, 2005, p. 3). Cardima's request for a hearing on its Revelation Tx ablation microcatheter system was granted in July (2"The Gray Sheet" July 24, 2006, p. 6)...

You may also be interested in...



CDRH Dispute Resolution Panel Set To Meet For First Time In Years

For the first time in over three years, the ombudsman of FDA's device center has referred a company to the Medical Device Dispute Resolution Panel

CorCap Efficacy Data Deemed Scant By Panel; Acorn Vows Not To Lose Heart

Acorn Cardiovascular will work with FDA to address panel concerns with CorCap that arose during a June 22 meeting to review the ventricular support device

Market Intel: Minimally Invasive Procedures Gaining Traction In BPH Treatment Market

Less-invasive technologies to treat benign prostatic hyperplasia are fast becoming viable alternatives to medication and surgery. Landmark studies of newer techniques have led the American Urological Association to update its guidelines.

UsernamePublicRestriction

Register

MT024107

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