TELA Bio, a surgical reconstruction company leading the development of Reinforced BioScaffolds (RBSs) for soft tissue repair, 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 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. These data have consistently demonstrated important performance advantages over commercially available biologic and synthetic materials."
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.
"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," said Dr. Stephen Ferzoco, a Boston-based hernia surgeon.
The OviTex portfolio includes six products with a range of sizes, thicknesses, and degrees of reinforcement that allows surgeons to choose the appropriate product for each procedure and surgical technique.
OviTex RBSs are available with either permanent (polypropylene) polymer or resorbable (polyglycolic acid) polymer reinforcement.
The FDA granted 510(K) clearance for the resorbable polymer products in March 2016 and recently granted the same clearance for permanent polymer products in June 2016. TELA Bio is poised to enroll post-market clinical studies following initial commercialization.
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"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. These data have consistently demonstrated important performance advantages over commercially available biologic and synthetic materials."
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.
"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," said Dr. Stephen Ferzoco, a Boston-based hernia surgeon.
The OviTex portfolio includes six products with a range of sizes, thicknesses, and degrees of reinforcement that allows surgeons to choose the appropriate product for each procedure and surgical technique.
OviTex RBSs are available with either permanent (polypropylene) polymer or resorbable (polyglycolic acid) polymer reinforcement.