Radi Medical Systems, Inc. Release: Legality Of Reprocessing Of FemoStop(R) Femoral Compression System
WILMINGTON, Massachusetts, December 7 /PRNewswire/ -- Radi Medical Systems, Inc (Radi), a designer and manufacturer of innovative devices in interventional cardiology, announced today that on November 2, 2004, the US Food and Drug Administration issued a ruling regarding the regulatory status of various reprocessed single use medical devices for which validation data were required under the Medical Device User Fee and Modernization Act of 2002. FemoStop(R) Femoral Compression System was included among these. The ruling stated that Adven Medical and Clear Medical may no longer legally market FemoStop(R) Femoral Compression System. The ruling also stated that SterilMed and Vanguard may only legally market FemoStop(R) Femoral Compression System, item number 017500.
Since the introduction of FemoStop(R), Radi Medical Systems has utilized the latest technology to improve this device. These improvements have resulted in the introduction of new versions of FemoStop(R), including FemoStop(R)plus Femoral Compression System (Item #11163) and FemoStop(R)HD Femoral Compression System (Item # 11161). These devices may not be marketed legally as reprocessed devices. The materials, components, and adhesives used in the manufacturing of these devices have only been validated for single use.
The only legally reprocessed FemoStop(R) (Item #017500) has not been marketed in the United States by Radi Medical Systems Inc. or any authorized distributor since 2002. Therefore, it is unlikely that your hospital has any inventory of legally reprocessed FemoStop(R). Please review your inventory to ensure that your hospital is not using FemoStop(R) products that have not been legally reprocessed.
To learn more about the FDA ruling regarding legal marketing of reprocessed single use medical devices, please visit http://www.radi.se/ or http://www.fda.gov/cdrh/reuse/svs/index.html
About Radi Medical Systems AB
Radi Medical Systems AB develops, manufactures, markets and sells medical devices in the field of interventional cardiology. The company is focused on two key areas: Intravascular Sensors (coronary physiology) and Hemostasis Management (products to stop bleeding after interventional cardiology procedures). In collaboration with physicians and institutions around the world, Radi Medical Systems is committed to meeting the needs of healthcare professionals and their patients through innovation, technology and expertise. In addition, Radi offers value added support through education and training. Headquartered in Uppsala, Sweden, the company has a total of 250 employees worldwide with subsidiaries in Australia, Germany, Japan, Thailand, Switzerland, BeNeLux, United Kingdom and in the United States.
Radi Medical Systems, Inc.CONTACT: Tobias Tullberg, Marketing Director, Radi Medical Systems,Inc., Telephone: +1-877-337-7234,Tobias.Tullberg@radimedicalus.com