January 7, 2015 — Minneapolis Heart Institute Foundation (MHIF) researchers have performed two implants of the Lotus Cardiac Valve System as part of the REPRISE III clinical trial. With these procedures, Minneapolis Heart Institute at Abbott Northwestern Hospital has become the third facility in the United States to perform Lotus valve implants, and the first west of the Mississippi.
The patients, who were the seventh and eighth to receive Lotus valve implants in the United States, are both 85-year-old women who suffered from advanced aortic valve stenosis and were deemed high-risk and ineligible for traditional valve replacements through open heart surgery.
Both patients underwent transcatheter aortic valve replacement (TAVR) procedures on Tuesday, November 11. They are both scheduled to return to Minneapolis Heart Institute at Abbott Northwestern to assess their progress and to determine whether their TAVR procedures were successful.
Clinical research into TAVR devices such as the Lotus Cardiac Valve System is important because it provides options to an underserved population – older patients that are generally considered too high-risk for open-heart surgery.
Wesley R. Pedersen, M.D., director of Transcatheter Valve Therapies for the Minneapolis Heart Institute at Abbott Northwestern Hospital is the principal investigator for this study. He states, “The ability of this valve to be fully repositioned offers an advantage over existing technology. If initial placement results in suboptimal function, it can be recaptured and moved to a slightly different position where valve function is most ideal.” In the United States the Lotus Valve System is an investigational device and not available for sale. It is CE marked in the European Union.
For more information: www.mplsheart.org