View all newsletters
Receive our newsletter - data, insights and analysis delivered to you
  1. News
January 2, 2018updated 22 Jul 2022 6:42am

FDA approves marketing of Dermapace System for diabetic foot ulcers

The US Food and Drug Administration (FDA) has granted approval to Sanuwave for the marketing of the Dermapace System designed to treat diabetic foot ulcers.

The US Food and Drug Administration (FDA) has granted approval to SanuWave for the marketing of the Dermapace System designed to treat diabetic foot ulcers.

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

The external shock wave device is intended to be used in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas measuring less than 16cm² that extends through to the epidermis, dermis, tendon, or capsule, without bone exposure.

The device uses pulses of energy, which is similar to sound waves, to mechanically stimulate the wound.

Patients who are 22 years and older and with diabetic foot ulcers lasting for more than 30 days can use Dermapace System with standard diabetic ulcer care.

FDA Center for Devices and Radiological Health surgical devices division director Binita Ashar said: “Diabetes is the leading cause of lower limb amputations.

“Additional options for successfully treating and healing ulcer wounds may help prevent lower limb amputations.”

“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.”

Before approving the device, FDA reviewed clinical data from two multi-centre, randomised, double-blind studies that saw a total of 336 diabetic patients receiving either usual care, which includes wet-to-dry dressings or debridement as needed, plus the Dermapace System shock wave therapy or usual care plus non-working (sham) shock wave therapy.

Both the groups included patients with poorly and well-controlled blood glucose levels.

The patients treated with one and seven doses of the Dermapace System demonstrated an increase in wound healing at 24 weeks with a 44% wound closure rate, while those treated with the sham shock wave therapy showed a 30% wound closure rate during the same time period.

Related Companies

Free Report
img

Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
Enter your details here to receive your free Report.

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU

Thank you for subscribing to Medical Device Network