PITTSBURGH, March 8 /PRNewswire/ -- ThermalTherapeutic Systems, Inc. today announced that the FDA has cleared the company to market its VERATHERM™ Portable Hyperthermic Perfusion System effective immediately.
"FDA clearance is a significant achievement for ThermalTherapeutic Systems, one which allows the company to place the VERATHERM™ Portable Hyperthermic Perfusion System in the hands of surgeons and perfusionists at luminary institutions across the country. For medical professionals -- for those who will benefit from using this technology -- FDA clearance represents a critical step forward in the company's ongoing effort to standardize the use and improve the control of hyperthermic perfusion", said Raymond F. Vennare, CEO of ThermalTherapeutic Systems.
The VERATHERM™ Portable Hyperthermic Perfusion System is small, lightweight and mobile device which provides the medical community with an economical platform to precisely deliver and circulate heated and unheated sterile fluids to a broad population of patients for a variety of appropriate indications and treatments. This device, the company believes, establishes a new standard for portable hyperthermic perfusion.
J. Michael Fausset, Chief Technology Officer for ThermalTherapeutic Systems -- a perfusionist with thirty years of clinical experience -- believes that the VERATHERM™ Portable Hyperthermic Perfusion System will not only improve the quality of hyperthermic treatments, in particular, but create opportunities for hospitals and perfusion groups to expand their services in general.
"The fact that this device precisely monitors temperature, pressure and flow allows the physician and technician to have more control over the treatment", said Fausset. "But because of its portability, more patients can be treated at more facilities or in different clinical environments".
Launch of the VERATHERM™ Portable Hyperthermic Perfusion System begins in April, 2010.
ThermalTherapeutic Systems, Inc. was founded in 2006 by a team of experts in the field of hyperthermic perfusion, medical device manufacturing, molecular diagnostics and technology commercialization. ThermalTherapeutic Systems is a product development company and the VERATHERM™ Portable Hyperthermic Perfusion System is the company's first product offering. The intended use of this device is to raise the core temperature of the thoracic or peritoneal cavity to the desired temperature by continuous lavage with circulating warmed, physiologically compatible sterile solution, according to a protocol selected by a physician (www.thermaltherapeutics.com).