Le Lézard
Classified in: Health, Science and technology
Subject: FDA

CSA Medical Announces FDA (510K) clearance of truFreeze® System, RapidAV spray catheter

BOSTON, July 17, 2017 /PRNewswire/ -- CSA Medical announced on Monday, an advancement of its catheter technology with the expansion of its truFreeze® catheter offerings to include a third Spray Kit for the truFreeze System, referred to as the Rapid AV Spray Kit. The Rapid AV catheter has a material property change such that it provides the ability to shorten the time to liquid nitrogen spray by 50%.  The shortened time to liquid nitrogen spray decreases treatment time overall as well.

The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (e.g. Barrett's Esophagus with high grade dysplasia) and malignant lesions.

truFreeze® is the only ablation technology that ablates Barrett's Esophagus with high grade dysplasia, or cancers such as in the esophagus, utilizing a non-contact liquid nitrogen spray cryotherapy system.  The truFreeze system makes it possible to deliver liquid nitrogen inside the body in a way that is far colder than is needed to effectively destroy these tissue types by a factor of >2.

"We are pleased to have obtained FDA clearance to expand our product offerings for our truFreeze System.  With the addition of the Rapid AV Spray Kit, it is anticipated that physicians will be able to substantially reduce treatment times such that patients have a shorter procedural time," says Ellen Sheets MD, CEO and President of CSA Medical. 

This product expansion reiterates truFreeze as a treatment option for Barrett's Esophagus, and malignant lesions and supports coverage decisions for truFreeze patient treatments.

About CSA Medical
CSA Medical, Inc. develops and manufactures a proprietary interventional spray cryotherapy technology platform utilizing unique properties of liquid nitrogen spray delivered by a software driven device with specialty catheters that enable delivery of spray cryogen inside the body to flash freeze and destroy unwanted tissue allowing for a rejuvenative pattern of healing. CSA manufactures and distributes this technology in the USA as the truFreeze® system which is currently used to ablate benign (e.g. Barrett's Esophagus with high grade dysplasia) and malignant lesions.

To learn more about our technology, please visit http://csamedical.com/.

truFreeze is a registered trademark of CSA Medical, Inc.

For further information contact:      
Jean Bjerke, CSA Medical
+1-781-538-4756 / jbjerke@csamedical.com

SOURCE CSA Medical, Inc.

These press releases may also interest you

at 04:00
Well-Defined Business Models and Added-Value Approach are Key LONDON, Oct. 23, 2017 /PRNewswire/ -- Payment Cards will become powered when they take on interactive form factors such as biometric sensors and Dynamic Code Verification (DCV). In...

at 04:00
LONDON, October 23, 2017 /PRNewswire/ -- Optimax, the UK's longest established vision correction specialist, has extended its range of implantable lenses with an advanced new addition. The Carl Zeiss AT LARA Premium IOL receives its official launch...

at 04:00
BERLIN, October 23, 2017 /PRNewswire/ -- From November 6 to 8, 2017, CityCube Berlin will host a virtual who's who on the international biotech scene. Investors, startups and leading decision makers from the biotech, pharmaceutical and finance...

at 02:58
STOCKHOLM, Oct. 23, 2017 /PRNewswire/ -- Medivir AB (Nasdaq Stockholm: MVIR)today communicates phase IIb data on JNJ-4178, the triple combination consisting of simeprevir, odalasvir and AL-335, following presentations at the 2017 Liver Meetingtm...

at 02:00
LONDON, October 23, 2017 /PRNewswire/ --   Kx technology to support BrainWaveBank as it uses AI to transform cognitive health -   Solutions based on Kx will allow individuals to monitor their cognitive health and allow BrainWaveBank to develop...

at 01:43
OSLO, Norway, Oct. 23, 2017 /PRNewswire/ -- Nordic Nanovector ASA (OSE: NANO) announces the following presentations by the company's research collaborators at the European Association of Nuclear Medicine annual meeting (EANM; 21-25 October; Vienna,...

News published on 17 july 2017 at 14:06 and distributed by: