Medtronic touts FDA win, commercial launch of next-gen FlexCath sheath

January 16, 2013 by MassDevice staff

Medical device company Medtronic wins FDA clearance for its 2nd-generation FlexCath Advance steerable sheath for use with the Arctic Front Advance cryoablation balloon system.

Medtronic's Arctic Front Advance cryoablation balloon system

Medical device maker Medtronic (NYSE:MDT) this week touted FDA clearance for its next-generation FlexCath Advance steerable sheath, launching U.S. commercial efforts immediately.

The new FlexCath Advance sheath is designed to work with Medtronic's Arctic Front Advance cryoablation balloon system, which treats irregular heartbeat by blocking electrical signals that trigger erratic rhythms in the heart's upper chambers.

The new sheath has several design improvements and is easier to use, according to a press release.

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"Building upon the Arctic Front System's proven platform, the FlexCath Advance Steerable Sheath augments the overall efficiency of the procedure," Medtronic vice president and AF Solutions general manager Reggie Groves said in prepared remarks. "It completes the Arctic Front Advance System and is the 4th new product we have launched in the U.S. market in 2 years."

Arctic Front Advance and an earlier generation of the device have treated more than 50,000 in 32 countries, according to Medtronic.