A UK-based medtech company has been given regulatory clearance from the U.S. Food and Drug Administration (FDA) for its Avelle Negative Pressure Wound Therapy (NPWT) system.
ConvaTec was given clearance from the US watchdog to enter into the $1.1 billion market.
The device combines negative pressure wound therapy with hydrofiber technology, and the pump can be used for up to 30 days. ConvaTec’s proprietary hydrofiber technology is designed to help create a beneficial moist wound environment for healing.
For patients, the Avelle NPWT system is designed to be lightweight, portable and easy-to-use, helping to give them more mobility and resume their daily activities, both in and out of the home, whilst their wounds progress towards healing.
Fiona Ada, interim president, advanced woundcare at ConvaTec said: “We are very pleased to bring the benefits of the Avelle NPWT system to healthcare professionals and patients in the U.S., where demand for disposable single-use negative pressure devices is growing at double digit rates. Customer response in European markets has been very positive, with clinicians and patients noting the disposable system’s ease of use as well as its suitability from hospital to home.
“At ConvaTec, we are committed to providing our customers with further differentiated technologies and complete solutions for managing chronic and acute wounds, and helping them improve outcomes with the right product, for the right patient, at the right time.”
The Avelle NPWT system can be used on a range of low-to-moderately-exuding wound types, including chronic, acute, traumatic, sub-acute and dehisced wounds, skin grafts, and surgically closed incisions.
