Tag: dermaPACE® System

FDA approves shock wave device for treatment of diabetic foot ulcers

Today, the U.S. Food and Drug Administration permitted the marketing of the Dermapace System, the first shock wave device intended to treat diabetic foot ulcers.

 

“Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, M.D., director of the division of surgical devices in FDA’s Center for Devices and Radiological Health. “The FDA is dedicated to making technologies available that can help improve the quality of life for those with chronic diseases. Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.”

 

An estimated 30.3 million people in the United States have been diagnosed with diabetes, according to the Centers for Disease Control and Prevention. Diabetes damages blood vessels and nerves, particularly in the feet, and can lead to severe infections that are difficult to treat. About 25 percent of people with diabetes will experience a foot ulcer in their lifetime. Amputation is sometimes necessary when circulation is so poor that a foot ulcer fails to heal or when treatment fails to stop the spread of an infection … read more

SANUWAVE Announces Exhibition at SAWC

 

SUWANEE, Ga., Jan. 19, 2018 (GLOBE NEWSWIRE) — SANUWAVE Health, Inc. (OTCQB:SNWV) is pleased to announce that the company will exhibit, SAWC (Symposium on Advanced Wound Care) in Charlotte, NC on April 25 – 29, 2018. This will be SANUWAVE’s first opportunity to present their flagship wound care device, the dermaPACE System, to the U.S. market since receiving US FDA clearance in December, allowing the Company to market the device in the US.

“We are excited to be back presenting at SAWC spring in Charlotte, our first time as an exhibitor in 8 years.  Since FDA clearance, the support coming from the wound care community has been overwhelmingly positive,”  Stated Kevin R. Richardson, CEO and Chairman of the Board.  Mr. Richardson continued, “We are glad to be making our shift from an R&D centered company to a marketing based company.  This will be the start of our reemergence in the wound care space.”  The Company is using this occasion to formally introduce their lead wound care product, the dermaPACE® System.  This Extracorporeal Shockwave Technology … read more