Leading healthcare products maker Covidien plc (COV) has won the 510 (k) clearance from the U.S. Food and Drug Administration (“FDA”) as well as the European CE Mark approval for its Parietex Optimized Composite (PCOx) mesh for ventral hernia repair. The Ireland-based company introduced the product at the recent European Hernia Society (“EHS”) meet in Belgium.
Ventral (or incisional) hernias, which generally occur in the abdominal wall around a previous surgical incision, results in a bulge or a tear in the area where the abdominal wall muscles have weakened. According to the Society of American Gastrointestinal and Endoscopic Surgeons (“SAGES”), roughly 90,000 ventral hernia repairs are performed annually in the U.S.
Ventral hernias are characterized by a number of symptoms including pain, bulge, nausea and constipation. If the hernia becomes strangulated (involves an irreducible bulge that is tightly squeezed or incarcerated) it potentially leads to serious complications and requires immediate medical attention. Surgical repair (such as mesh or suture techniques), which can be performed laparoscopically, is a widely used treatment option for ventral hernias.
PCOx, the next-generation version of Covidien’s legacy ParietexComposite (“PCO”) mesh (introduced in 1999), has been geared to better address surgeon and patient needs in open and laparoscopic ventral hernia repair. It has been designed to incorporate greater resistant barrier compared to its predecessor. The PCOx mesh is thrice more resistant than PCO and its proprietary textile design allows improved visibility through the mesh.
Covidien is a leading global healthcare products company that develops and markets medical solutions for better patient outcomes. The company’s core medical devices business faces stiff competition from Johnson & Johnson (JNJ), Becton Dickinson (BDX) and C.R. Bard (BCR).
Covidien’s hernia repairs products represents a part of soft tissue repair business which generated sales of $854 million in fiscal 2010. The acquisition of tissue implant products maker Tissue Science Laboratories in fiscal 2008 has enabled the company to expand its foothold in the hernia repair market allowing it to market a comprehensive suit of products.
Covidien boasts a well diversified product and technology portfolio. The company remains committed to rolling out new products and technologies, focusing on faster-growing products and markets, and boosting market share in core segments through investments in sales and marketing infrastructure.
However, Covidien’s hernia repair franchise faces increased challenges as rival C.R. Bard continues to strengthen its foothold in this market with new products (including the laparoscopic ventral hernia repair product Echo PS Mesh Positioning System).
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