Irvine, Calif., medical device maker Reverse Medical Corp. touted FDA clearance for its flagship product, the MVP micro vascular plug for peripheral artery embolization.
The plug helps decrease blood flow in the peripheral vasculature and is "completely re-sheathable" for use in procedures where a patient needs only temporary blood flow reduction.
"I’m very enthusiastic about our timing with this technology, as the Embolization market is poised for dramatic growth," Reverse president & CEO Jeffrey Valko said in prepared remarks. "We forecast more than 75,000 annual procedures in the US alone."
In addition to the FDA nod, Reverse also touted the 1st U.S. clinical cases of treatment with MVP, which the company called "impressive." The company has launched commercial efforts for the MVP device, citing "profound clinical success" demonstrated by its clinical evaluation study.
The U.S. regulatory win comes on the heels of similar approval notched in Europe, where Reverse Medical in June treated the 1st patients.