FDA approves shock wave wound healing device

pharmafile | January 2, 2018 | News story | Manufacturing and Production, Sales and Marketing FDA, biotech, drugs, pharma, pharmaceutical 

Continuing its recent trend to promote innovative new technologies, the FDA has announced that it has approved a medical device that uses shock waves to help promote wound healing in those suffering from diabetes.

In particular, the device will be able to be used to heal foot ulcers in patients whose wounds have not closed in more than 30 days of standard treatment.

The product, called the Dermapace System, sends acoustic shock waves, similar to soundwaves, that stimulate patients’ wounds to accelerate the healing process.

Though it may sound more akin to science fiction, the device was shown to have benefits in two randomised, double-blind clinical trials. The two studies, including 336 patients, revealed that patients who received between one and seven stimulations with the device showed greater efficacy than standard treatment alongside placebo treatment.

In total, 44% of patients receiving treatment with the Dermapace System were revealed to have experienced wound closure at 24 weeks, whilst only 30% of those receiving placebo treatment were able to show the same.

Despite only involving shock waves, there were side-effects reported from the system – with the most common involving local bruising, numbness, migraines and nausea.

The device was reviewed through the de novo premarket review pathway, a process by which low- to moderate-risk devices are tested.

“Diabetes is the leading cause of lower limb amputations,” said Binita Ashar, 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.”

The FDA referenced that there are an estimated 30 million individuals currently diagnosed with diabetes, and with 25% of those likely to experience a foot ulcer in their lifetime.

Ben Hargreaves

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