Surgical reconstruction company Tela Bio said yesterday it won FDA 510(k) clearance for its Ovitex portfolio of ventral hernia repair and abdominal wall construction reinforced bioscaffold products.
The Malvern, Penn.-based company said it is launching the portfolio of devices in the U.S. upon receiving clearance from the federal watchdog.
“We are committed to collaborating closely with leading surgeons to reinvigorate the soft tissue reconstruction implant market and bring high performance, cost-effective solutions to hospitals, surgeons and patients. Surgeons have been telling us that integrating polymer and biologic materials represented a necessary evolution in hernia repair that minimizes the amount of foreign material left behind and provides the promise of a durable repair. We have developed an extensive pre-clinical research data set to support our products. These data have consistently demonstrated important performance advantages over commercially available biologic and synthetic materials,” CEO Antony Koblish said in a press release.
The OviTex RBS devices are designed for soft tissue repair, and are designed from an embedded polymer and intact extracellular matrix.
“Without an ideal surgical mesh implant, over the last decade many surgeons have focused on learning novel hernia repair techniques to accommodate for older technology implants. The reinforced technology in the OviTex portfolio combines the strength advantages of synthetics with a natural biologic material, offering the best of both worlds and helping surgeons achieve successful patient outcomes without the need to learn new techniques,” Dr. Stephen Ferzoco said in prepared remarks.
Tela Bio’s portfolio is composed of 6 products in various sizes, thicknesses and different degrees of reinforcement to allow for appropriate selection dependant upon procedure and surgical technique required.