Printer Friendly
The Free Library
6,673,945 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Ascent Healthcare Receives 510(k) Clearance on Medtronic TORQR CS Series Catheters.


PHOENIX -- Ascent Healthcare Solutions (formerly Alliance Medical Corp. and Vanguard Medical Concepts) announced today that the Food and Drug Administration (FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
) has cleared Ascent's 510(k) to reprocess re·proc·ess  
tr.v. re·proc·essed, re·proc·ess·ing, re·proc·ess·es
To cause to undergo special or additional processing before reuse.

Verb 1.
 the TORQR([R]) CS Series EP catheters manufactured by Medtronic(1).

Reprocessing Reprocessing may refer to:
  • Nuclear reprocessing
  • Recycling
 diagnostic EP catheters Co specially designed electrode electrode, terminal through which electric current passes between metallic and nonmetallic parts of an electric circuit. In most familiar circuits current is carried by metallic conductors, but in some circuits the current passes for some distance through a  instruments that transmit electrical impulses Co reduces the cost of an EP study by an average of $300 to $500. A hospital that performs 1,000 or more studies each year could save between $250,000 and $1 million annually. Through rigorous, FDA-approved testing and validations, these devices are assured to be as safe as they were in original condition.

Medtronic Cardio Rhythm Torqr Catheters are fixed curve devices intended for use in diagnostic electrophysiology electrophysiology /elec·tro·phys·i·ol·o·gy/ (-fiz?e-ol´ah-je)
1. the study of the mechanisms of production of electrical phenomena, particularly in the nervous system, and their consequences in the living organism.

2.
 (EP) procedures. They record intracardiac intracardiac /in·tra·car·di·ac/ (-kahr´de-ak) within the heart.

in·tra·car·di·ac
adj.
Within the heart.



intracardiac

within the heart.
 electrograms and temporary pacing associated with EP studies.

"Through our predecessor companies, Ascent has been a leader in reprocessing a broad array of EP catheters for hospitals around the country," said Don Selvey, vice president of Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas:
 and Quality Assurance for Ascent. "In fact, we are unmatched in our depth of expertise in reprocessing these extremely popular devices. Last year alone, for instance, we reprocessed more than 266,000 EP catheters arising from 462 unique model numbers."

Collectively, Ascent has safely reprocessed more than 50 million SUDs for over 1,700 healthcare facilities nationwide. Ascent expects to help its customers save in excess of $92 million in supply expenses in the coming year, which may be redirected to patient services. In addition, the company expects to eliminate over 7,000 tons of medical waste from the nation's landfills annually.

(1) TORQR is a registered trademark of Medtronic, Inc.

About Ascent Healthcare Solutions

Ascent Healthcare Solutions, the leading independent third-party reprocessor of specific single-use medical devices (SUDs), has reprocessed more than 50 million SUDs for over 1,700 healthcare facilities nationwide. The company's primary reprocessing center and home office are in Phoenix, Ariz. with an additional reprocessing center in Lakeland, Fla. Ascent holds agreements with all leading national group purchasing organizations A group purchasing organization is an entity that leverages the purchasing power of a group of businesses to obtain discounts from vendors based on the collective buying power of the GPO members. Many GPOs are funded by administrative fees that are actually paid by the vendors.  as well as numerous nationally recognized hospital integrated delivery networks that collectively represent more than 5,000 healthcare facilities. For more information about Ascent Healthcare Solutions, visit www.ascenthealthcaresolutions.com.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Date:Sep 26, 2006
Words:368
Previous Article:Cdigix Experiences Increased Demand from Large Public Universities Nationwide Including the University of Washington, the University of Colorado at...
Next Article:New Alternative Trading System (ATS) To Be Launched.
Topics:



Related Articles
Ascent Healthcare Solutions Receives 510(k) Clearance for Phacoemulsification Tips; Latest 510(k) Clearance Demonstrates Ascent's Commitment to...
Ascent Healthcare Solutions Receives FDA Clearance to Increase Cycle Count for Reprocessed EP Catheters.
Ascent Healthcare Solutions Receives 510(k) Clearances for Compression Sleeves.
Ascent Healthcare Receives 510(k) Clearance on Zimmer TransFx External Fixation Devices.
Medtronic Announces CE Mark Approval of the World's First Transcatheter Valve Replacement System for Structural Heart Disease.
Medtronic Announces FDA 510(k) Clearance of Next-Generation Export(R) XT Aspiration Catheter.
Hansen Medical Showcases New Generation Robotic Catheter Technology at Boston Atrial Fibrillation Symposium.
Generic Medical Devices Receives 510(k) Clearance for the GMD Universal Circumcision Clamp.
FIRST HEART ATTACK PATIENT ENROLLED IN RAPID MI-ICE STUDY.
Ascent Healthcare Receives 510(k) Clearance to Reprocess Siemens ACUSON AcuNav(TM) Ultrasound Catheter up to Four Times.

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles