Covidien launches first U.S. product from its Confluent Surgical acquisition

November 12, 2009 by MassDevice staff

Three years after purchasing Confluent Surgical for $245 million, the medical device colossus launches the DuraSeal Spine Sealant in the U.S.

It took seven years and a $245 million merger, but the DuraSeal Spine Sealant finally hit the market in the U.S.

Covidien (COV) launched DuraSeal at the North American Spine Society Annual Meeting in San Francisco Nov. 12, three years after landing the technology in its acquisition of Confluent Surgical. The sealant is a hydrogel-based technology created by serial inventor and entrepreneur Amar Sawhney, who founded Confluent Surgical in 1998, invented the technology behind DuraSeal in the early 2000s and sold it to Covidien in 2006.

The product is designed to protect against dural tears during or after spine surgery. These tears of the outermost membrane covering the brain and the spinal cord can result in cerebro-spinal fluid leaking into the body.

Covidien public relations manager David Young told MassDevice that the company is upbeat about DuraSeal and its market potential, calling it "amazing technology." Young confirmed that the product is the first to come out of the Confluent merger in the United States. He added that the company has released three other products in the EU that it acquired in the merger, including the Sprayshield Adhesion Barrier System, which was released in 2008.

Confluent, which Sawhney launched with a $1 million seed round in 1998, first started clinical trials on a dural sealant in 2002, shortly after raising another $20 million in a Series B round.

At the time, Confluent was already marketing its SprayGel Adhesion Barrier System, which is designed to prevent or reduce the formation of scar tissue adhesions in the abdominal or pelvic cavity after surgical procedures. By the time of the merger with Covidien (then Tyco Healthcare), Confluent had received a regulatory nod from the Food & Drug Administration to market DuraSeal in the United States for cranial surgery and the CE Mark for spinal applications in the European Union. Covidien won FDA clearance for using DuraSeal in spinal procedures in September.

Covidien estimated that about 10 percent of the 1.5 million spine surgeries performed in the U.S. require dural repair and sealing.