Sweden-based XVIVO Perfusion landed a date with the FDA to review Humanitarian Device Exemption for its XVIVO Perfusion System for preserving donor lungs.
XVIVO will meet on March 20 with the FDA’s Gastroenterology & Urology Devices Panel to review data on the device, which provides continuous perfusion of otherwise unacceptable lung tissue, allowing clinicians to reevaluate the organs for transplantation.
More than 80 patients were included in XVIVO’s U.S. clinical study of perfusion with the company’s STEEN solution, according to a company statement. FDA regulators determined in an earlier meeting with the company that participating clinics may continue continue using the STEEN solution and that the clinical trial may add more centers.
The STEEN solution is already available on the U.S. market, and the company hopes to land CE Mark approval for its perfusion system early this year.
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