FDA Greenlights Historical Control In Trial Of Regentis' GelrinC Knee Repair Material
The pivotal clinical study will support a US pre-market approval to allow Regentis Biomaterials to market GelrinC for the repair of focal knee cartilage defects in the knee, the largest unmet need in orthopedic sports medicine, according to the company.
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Derived from Strategic Transactions, Informa’s premium source for tracking life sciences deal activity, the Medical Device Deals Update column is a survey of recent medtech M&A, alliance, and financing activity. This month’s column covers deals announced January-February 2016.
New trial data shows Boston Scientific’s Sentinel cerebral embolic protection device may reduce the risk of disabling stroke, but it does not appear to reduce the overall risk of stroke.
Edwards Lifesciences is ramping up US commercialization of its Pascal Precision mitral valve transcatheter edge-to-edge repair device, the first US competitor for Abbott’s MitraClip. The FDA approved Pascal Precision earlier than the company expected, based on results of the CLASP IID trial.