British medical technology company ConvaTec Group has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Avelle negative pressure wound therapy (NPWT) system, paving the way for the company’s entry into the $1.1bn US NPWT market.
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.
The disposable device combines negative pressure wound therapy with the benefits of Hydrofiber Technology, and the pump can be used for up to 30 days.
ConvaTec’s Hydrofiber Technology, which is also used in the company’s AQUACEL line of advanced dressings, helps create a moist wound environment for healing.
Avelle, Hydrofiber and AQUACEL are trademarks of ConvaTec.
The Avelle NPWT system, the only product that offers the combination of advanced wound care technologies, is lightweight, portable and easy-to-use, and provides patients with more mobility and helps them resume their daily activities, while their wounds heal.
The Hydrofiber Technology also helps prevent periwound maceration, a complication associated with NPWT that can prolong healing.
The Avelle NPWT system delivers therapy in a canister-less system, and offers flexibility across varius care settings. The ergonomically-shaped pump can be placed in a pocket and it runs quietly.
Unlike other pumps which have shorter lifetime, the disposable pump has a 30-day lifetime, providing the option of extended therapy with a single device.
The Avelle NPWT system can be used on a range of wound types, including chronic, acute, traumatic, sub-acute and dehisced wounds, skin grafts, and surgically closed incisions.
It is currently available in 24 markets, including the UK, Germany, France, Canada, Australia and South Africa.
ConvaTec advanced wound care interim president Fiona Adam said: “We are very pleased to bring the benefits of the Avelle NPWT system to healthcare professionals and patients in the US, 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.