Technology | July 10, 2014

FDA Approves Investigational Device Exemptions for ThermoSuit Cooling System


July 10, 2014 — Life Recovery Systems announced the U.S. Food and Drug Administration (FDA) has approved two investigational device exemptions (IDEs) to study the use of the ThermoSuit system in the treatment of heart attack and ischemic stroke. Patients in both trials will be cooled while under sedation, with the intent of reaching a state of therapeutic hypothermia in approximately 30 minutes or less.

"We are eager to see our rapid cooling treatment evaluated in victims of heart attack and stroke, as preliminary data predict that cooling will be most effective if it is provided close to the time of reperfusion," said Robert Schock, Ph.D., vice president of R&D for Life Recovery Systems.

The ThermoSuit system uses direct liquid contact with the patient to reduce core body temperature. A thin film of ice water is circulated over the patient's body until the temperature reaches a preset limit, at which point the water is automatically removed from the suit. The system is easily set up by nurses or technicians in minutes and cools to a therapeutic temperature of 33?C in about 30 minutes. The patient is then removed from the suit and remains cold for hours without the need for further maintenance, allowing unencumbered access for imaging or treatment in the cath lab.

For more information: www.life-recovery.com

Related Content

Feature | Cath Lab

November 15, 2021 — RealView Imaging Ltd. recently received FDA 510(k) clearance for its Holoscope-i holographic system ...

Home November 15, 2021
Home
News | Cath Lab

November 10, 2021 — Shockwave Medical a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely ...

Home November 10, 2021
Home
News | Cath Lab

November 10, 2021 — Philips Healthcare announced North American availability of new innovations in its portfolio of ...

Home November 10, 2021
Home
News | Cath Lab

October 6, 2021 — Boston Scientific Corp. announced it entered into a definitive agreement to acquire Baylis Medical ...

Home October 06, 2021
Home
News | Cath Lab

September 21, 2021 — Medtronic is recalling its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device ...

Home September 21, 2021
Home
Feature | Cath Lab | By Aaron Detate and Lars Thording

In the electrophysiology (EP) lab, hundreds of thousands of used devices are sent to reprocessors every year to get ...

Home September 14, 2021
Home
News | Cath Lab

July 22, 2021 — Medis Medical Imaging is partnering with CORRIB Core Lab and Sinomed in randomized clinical trial of ...

Home July 22, 2021
Home
News | Cath Lab

July 13, 2021 — East End Medical announced it received U.S. Food and Drug Administration (FDA) clearance for the company ...

Home July 14, 2021
Home
Feature | Cath Lab | By Dave Fornell, Editor

There is a trend in interventional cardiology that is now being called “renalism,” where patients with poor renal ...

Home May 14, 2021
Home
News | Cath Lab

May 12, 2021 — Abbott recently announced its new interventional imaging platform powered by Ultreon 1.0 Software, has ...

Home May 12, 2021
Home
Subscribe Now