Minnesota medical device maker St. Jude Medical (NYSE:STJ) this week released results from clinical trials of its 23 mm and 25 mm Portico transcatheter aortic valve implantation devices, touting patient health improvements and low adverse events at 30 days.
The Portico system aims to address challenges discovered with early generations of TAVI technology, including difficulty getting the cardiac implants positioned accurately, valve leakage and heart block development that requires permanent pacemaker implantation, among other issues. The device can be fully re-sheathed into its delivery catheter during the procedure, allowing a cardiologist to reposition the device or retrieve it entirely.
Lead investigator Dr. Ganesh Manoharan presented 1-month results from the Portico CE study of 84 patients, reporting a 3.6% mortality rate, 2.4% major stroke rate, 10.8% pacemaker implantation rate and 10.8% major bleeding rate, results that Manoharan referred to as "an excellent safety profile."
"St. Jude Medical has a long history of developing world class heart valve technologies. Today’s positive results speak to our capability and commitment to bring meaningful advancements to patients with heart valve disease," company cardiovascular & ablation technologies president Frank Callaghan said in prepared remarks.
The study was initiated to evaluate the 23 mm Portico valve, which last year won CE Mark approval in the European Union, and the trial was expanded to include the 25 mm valve, which is currently under regulatory review.
St. Jude is pretty far behind its rival medtech giants in terms of getting a TAVI device on the market, following Edwards Lifesciences’ (NYSE:EW) FDA-approved Sapien system and Medtronic’s (NYSE:MDT) CoreValve, which is slated to hit the U.S. market next year.
TAVI systems have gotten a lot of attention at this year’s TCT conference, where researchers discussed the cost-effectiveness of extending the procedure to lower-risk patients, Medtronic delved deeper into 1-year “real-world” clinical results for its CoreValve system, and researchers pitted CoreValve and Sapien against one another, finding few differences outside of a higher pacemaker implantation rate for CoreValve.
