Printer Friendly

THERMO CARDIOSYSTEMS REACHES NEXT STEP IN FDA APPROVAL PROCESS FOR IMPLANTABLE DEVICE

 WOBURN, Mass., Jan. 5 /PRNewswire/ -- Thermo Cardiosystems Inc. (AMEX: TCA) has reached the next step in its premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) seeking commercial approval for the company's air- driven heart-assist device. The FDA's response, as expected, consisted of additional questions and points for the company to clarify. Thermo Cardiosystems believes that several rounds of questions may occur during the premarket approval process for this implantable medical device. The companyUs PMA application was submitted to the FDA on March 31, 1992, and, in July, was given a formal filing date retroactive to March.
 Victor L. Poirier, president of Thermo Cardiosystems, explained, "It is important to remember that this is the first implantable heart-assist device for long-term use to be formally accepted by the FDA for PMA review. Obviously, the FDA is going to be very thorough with the first of any new medical device." Based on previous regulatory experience with the FDA, the company expects that it may take several months to satisfactorily respond to this round of questions. "There were no issues in the FDA's response that came as a surprise to us," said Poirier. "We had anticipated a significant number of questions."
 Once Thermo Cardiosystems has satisfied the FDA' questions, the application will be sent to a specially chosen advisory panel for their review. The company must also demonstrate to the FDA that the LVAD complies with all applicable performance and manufacturing standards.
 Thermo Cardiosystems'left ventricular-assist device, or LVAD, is designed to take over the pumping function of the heart's left ventricle in patients whose failing hearts are no longer strong enough to beat on their own. During clinical trials over the past six years, Thermo Cardiosystems' LVAD has been used in more than 100 patients awaiting heart transplantation.
 Thermo Cardiosystems Inc. is a leader in research and development of implantable ventricular-assist devices. These devices are designed to perform substantially all or part of the pumping function of the left ventricle of the natural heart for patients suffering from cardiovascular disease. The company's devices are currently intended for investigational use only. Thermo Cardiosystems Inc. is a public subsidiary of Thermedics Inc. and Thermo Electron Corporation.
 -0- 01/05/92
 /CONTACT: John N. Hatsopoulos of Thermo Electron, 617-622-1111/
 (TMO TCA)


CO: Thermo Electron Corporation; Thermo Cardiosystems ST: Massachusetts IN: SU:

TM -- NE008 -- 1613 01/05/93 09:59 EST
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Jan 5, 1993
Words:398
Previous Article:THERMO PROCESS SYSTEMS ACQUIRES OREGON SOIL-RECYCLING CENTER
Next Article:EQUITY OIL COMPANY ANNOUNCES SIGNING OF PRODUCTION SHARING CONTRACT FOR EXPLORATION IN EASTERN SIBERIA
Topics:


Related Articles
THERMO CARDIOSYSTEMS SUBMITS CARDIAC-ASSIST DEVICE FOR FDA REVIEW
FDA ACCEPTS THERMO CARDIOSYSTEMS' HEARTMATE PMA APPLICATION FOR FILING AND FORMAL REVIEW
PATIENTS ON THERMO CARDIOSYSTEMS ELECTRIC HEART PUMP GET OK FROM FDA TO LEAVE THE HOSPITAL
FDA PANEL RECOMMENDS COMMERCIAL APPROVAL FOR THERMO CARDIOSYSTEMS' HEARTMATE LVAD
THERMO CARDIOSYSTEMS RECEIVES EUROPEAN APPROVAL FOR COMMERCIAL SALE OF CARDIAC-ASSIST DEVICE
HEARTMATE SYSTEM BECOMES FIRST IMPLANTABLE CARDIAC-ASSIST DEVICE TO BE APPROVED FOR COMMERCIAL SALE IN THE U.S.
THERMO CARDIOSYSTEMS' ELECTRIC HEART PUMP APPROVED AS AN ALTERNATIVE TO TRANSPLANT IN SWEDEN
FDA AUTHORIZES CLINICAL USE OF BATTERY-OPERATED HEARTMATE DEVICE AS ALTERNATIVE TO TRANSPLANT
Thermo Cardiosystems Files Data For FDA Review in Anticipation of Commercial Approval for Electric Heart Pump
Thermo Cardiosystems Receives Approval to Expand Rematch Study

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters