TELA Bio's OviTex RBSs implanted in 100 hernia repair procedures since FDA clearance in June 2016

Surgical mesh integrating polymer and biologic materials received FDA 510(k) clearance in June 2016.

TELA Bio, Inc., a surgical reconstruction company leading the development and commercialization of Reinforced BioScaffolds (RBSs) for soft tissue repair, today announced the company’s OviTex™ RBSs have been implanted in more than 100 hernia repair procedures since receiving U.S. Food and Drug Administration (FDA) 510(k) clearance in June 2016.

“We are focused on bringing innovative, cost-effective, surgical reconstruction solutions that deliver benefits for a variety of patient types, surgical techniques, and hospital environments,” said Antony Koblish, president and CEO of TELA Bio. “Based on initial feedback from surgeons, the OviTex portfolio is delivering the benefits of both polymer and biologic materials for a durable repair that minimizes the amount of foreign material left behind in a range of procedures including ventral, umbilical, inguinal, and hiatal hernias using a variety of techniques including open, laparoscopic and robotic repairs.”

Surgical mesh reinforces soft tissue to improve long-term recurrence rates following hernia repair procedures. Previously, surgeons had to choose between biologic meshes that remodel into a patient’s natural tissue, or synthetic meshes that provide strength but introduce a foreign body that results in prolonged inflammation in patients. OviTex RBSs integrate 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.

“OviTex RBSs represent an advanced evolution in soft tissue reinforcement materials,” said Salvatore J. Pacella, MD, MBA, FACS, division head of plastic and reconstructive surgery at Scripps Clinic and Scripps Green Hospital in La Jolla, California. “The engineered design of OviTex integrates both biologic and synthetic materials synergistically. I have found this to be a great fit for the needs of our patients suffering from advanced abdominal wall hernias. The strength of a synthetic and the flexibility of a biologic are an ideal reinforcement. I have used the device in several challenging hernia patients thus far and have been very impressed by its ease of incorporation and the patient outcomes.”

“OviTex is an exciting new product for my abdominal wall reconstructions and hiatal hernia repairs,” said Michael Sawyer, MD, general surgeon at Comanche County Memorial Hospital. “The product’s handling characteristics are ideal for these repairs and its ability to absorb blood and fluids in the wound is unlike any other product on the market today.”

The OviTex portfolio includes six products that are available with either permanent (polypropylene) polymer or resorbable (polyglycolic acid) polymer reinforcement.