FDA Clears Surgical Adhesion Prevention Product

Biomatrix Inc. (Ridgefield, NJ) has received FDA 510(k) clearance to market its HylaSine viscoelastic gel device for injection into the sinus cavities during and following sinus surgery. The product is designed to coat surgically altered tissue, to still intra-operative and post-operative bleeding, to reduce post-surgical scarring and adhesions, and to minimize patient discomfort.

"The market potential for an effective anti-adhesive product for this otolaryngological indication is very promising, as it could be used in most sinus surgeries to improve the outcome of the procedure, benefit the patient, and save the healthcare system from the expense of costly re-operations," said Endre A. Balazs, Biomatrix' CEO and chief scientific officer.

"The commercialization of HylaSine contributes significantly to the development of our hylan technology platform and complements the anti-adhesive technology program of our proposed merger partners, Genzyme Surgical Products and Genzyme Tissue Repair. The combination of these innovative technologies should enable the new company to emerge as the preeminent global leader in adhesion prevention," Balazs added.

Edited by Ursula Jones