TELA Bio, Inc., a surgical reconstruction company, announced the commercial launch of the company’s OviTex™ portfolio of products for use in ventral hernia repair and abdominal wall reconstruction following U.S. Food and Drug Administration (FDA) 510(K) clearance. OviTex Reinforced Bioscaffolds (RBSs) feature an embedded polymer and an intact extracellular matrix (ECM), a biologic building block derived from ovine rumen, in layered constructs designed for multi-directional cell repopulation and healthy tissue remodeling.
“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,” said Antony Koblish, president and CEO of TELA Bio. “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.”
In the U.S. there are about 350,000 ventral hernia repairs performed each year, representing a common but often challenging procedure for general and plastic reconstructive surgeons. In an effort to improve long-term recurrence rates, surgical meshes are often used to reinforce soft tissue.
Currently available options for soft tissue reinforcement include biologic materials that provide a scaffold for cellular repopulation and remodel into a patient’s tissue, or synthetic materials that are less prone to laxity issues seen with some biologics. However, neither option is ideal. Clinical results with biologics are mixed over time, proving increasingly unacceptable given their high cost.
Long-term presence of synthetics in patients has been shown to pose risks due to a sustained inflammatory response, and they also have been shown to complicate future abdominal surgeries, which many of these patients undergo. TELA Bio seeks to fill a product innovation void in the market by purposefully designing implants that integrate polymer and biologic materials, harnessing their benefits and mitigating their pitfalls.
OviTex RBSs are available with either permanent (polypropylene) polymer or resorbable (polyglycolic acid) polymer reinforcement.
