Covidien has made an announcement that it obtained FDA approval for the DuraSeal™ Spine Sealant, a synthetic hydrogel indicated for closure of dural tears that occur during spine surgeries. According to MassDevice, it took seven years and a $245 million merger of Covidien with Confluent Surgical to deliver DuraSeal to the market.
From the press release:
In a clinical study of more than 150 patients, DuraSeal spine sealant was shown to be superior at achieving an intra-operative watertight seal, compared with the control group, which consisted of conventional methods of dural closure such as sutures or fibrin sealants. DuraSeal spine sealant achieved an intra-operative watertight seal 100% of the time, compared with 64% of the time by the control group. The safety results between the two groups were similar, given the patients’ medical conditions and the nature of the complex spinal procedures performed.
The new sealant is a 100% synthetic hydrogel that provides excellent tissue adherence, is absorbed by the body and is easy to apply. Stored at room temperature, DuraSeal spine sealant takes only two minutes to prepare and three seconds to set, which enables surgeons to achieve an intra-operative dural seal quickly.
Press release: Covidien Introduces First FDA-Approved Spine Sealant …
Product page: DuraSeal …
