| Public Health Service Food and Drug Administration |
| 10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
WARNING LETTER
Robert J. Freedman, Jr., M.D., F.A.C.C.
President and Chief Executive Officer
Life Recovery Systems HD, LLC
150 Hopper Avenue
Waldwick, New Jersey 07463
Re: ThermoSuit Systems™
JUL 28 2010
Dear Dr. Freedman:
Refer to CTS #1000176 when replying to this letter
The Food and Drug Administration (FDA) has learned that your firm is marketing the ThermoSuit™ Systems in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
The ThermoSuit™ System is a device within the meaning of Section 201 (h) of the Federal Food, Drug, and Cosmetic Act. The ThermoSuit™ System was cleared under K061023 and is intended for temperature reduction in patients where clinically indicated, e.g., in hyperthermic patients, and in monitoring patient temperatures. The ThermoSuit™ System is indicated for patients greater than 58" (147 cm) and less than 75" (190 cm) in height and less than 26" (66 cm) in width.
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) has reviewed your Web site at http://www.life-recovery.com. which includes links to several advertisements from peer-reviewed journals, articles, and video presentations that promote the ThermoSuit™ System for new intended uses. A review of our records reveals that you have not obtained marketing approval or clearance for the uses promoted on your Web site, which is a violation of the law.
Specifically, your Web site promotes the ThermoSuit™ System for the prevention of permanent tissue and neurological damage, for increasing survival rate in cardiac arrest patients, and for limiting damage to the brain and tissues after cardiac arrest. The following claims may be accessed through your Web site's homepage and include, but are not limited to:
• "King's Daughters Medical Center has a groundbreaking new medical device to increase the survival rate of cardiac arrest patients. The ThermoSuit™ System rapidly cools the body temperature to limit damage to the brain and tissues after a cardiac arrest."(From http://www.kdmc.com/visitors/default.aspx?id=24380)
• "Although this study [which consists of conductive-immersion surface cooling using the ThermoSuit® System] was not designed to demonstrate impact on outcomes, survival and neurologic function were superior to those previously reported " (From Resuscitation Vol. 81: Issue 4, Pages 388-392)
• " ...the ThermoSuit System™ (TSS) from Life Recovery System (LRS) is a rapid non-invasive patient cooling device that reduces the risk of brain or heart damage." (From MedicalDevice-Network.com)
• "Ochsner is one of only about 50 medical facilities that use a novel cooling therapy called the ThermoSuit. ... [T]hat has translated into far lower rates of brain damage in patients at centers using the device."(Excerpted from the January 2010 issue of Good Housekeeping)
• "The ThermoSuit™ System is the most advanced technology to treat cardiac arrest patients today." (From Ochsner Health System press release dated May 6, 2008)
Additionally, your Web site contains a video promoting the ThermoSuit™ for the treatment of cardiac arrest patients. Specifically, the video states:
• "Emergency room staff at Ochsner Medical Center are using what is called a ThermoSuit™ in an effort to increase the survival rate of cardiac patients."
• Dr. Paul McMullen states: "So far, the only thing that hypothermia has been proven to help in human research is the brain in cardiac arrest. We believe that if one could lower the body temperature and lower the temperature of the heart tissue before the arteries reopen, then we could limit significantly the amount of damage that's done by the heart attack."
These claims cause the ThermoSuit™ to be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351 (f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The ThermoSuit™ is also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the device into commercial distribution for such uses, as required by sections 510(k) of the Act, 21 U.S.C. 360(k). For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
The Office of Compliance requests that Life Recovery immediately cease the dissemination of promotional materials for the ThermoSuit™ System that are the same as or similar to those described above. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil money penalties.
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for ThermoSuit™ System that are the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to LCDR Michelle E. Noonan, Acting Chief, Vascular & Circulatory Support Devices Branch, Division of Enforcement B, Office of Compliance at the Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002, facsimile at 301847-8139. We remind you that only written communications are considered official.
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for the ThermoSuit™ System comply with each applicable requirement of the Act and FDA implementing regulations.
Sincerely,
/S/
Timothy A. Ulatowski
Director
Office of Compliance
Center for Devices and
Radiological Health
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