Medical devices major St. Jude Medical Inc. (STJ) has reached yet another important clinical landmark by registering the first implant of its next-generation 25 mm Portico transcatheter aortic heart valve implant ("TAVI") using the Transfemoral Delivery System in a European clinical study.
The Portico Transfemoral European Trial (Portico TF EU Trial) was originally designed to evaluate the safety and efficacy of the 23 mm Portico valve in patients with severe aortic stenosis (abnormal narrowing of the aortic valve opening). It has now been extended to incorporate the 25 mm valve to conduct research on patients in need of larger-sized valves. The non-randomized trial will be conducted across multiple centers in Europe enrolling at least 50 patients, who will be monitored for a year.
Results from the original study were used to support the 23 mm Portico device's European CE Mark approval in Nov 2012. The latest study on the 25 mm Portico valve will also help to gain clearance from the European Union.
However, both the devices are not yet approved by the U.S. Food and Drug Administration (FDA). As a result, the company is planning to launch a U.S. trial toward the end of the year. The company's bigger rival Medtronic's (MDT) TAVI product - the CE Marked CoreValve - is currently undergoing evaluation in a pivotal trial in the U.S.
The Portico valve from the company's Cardiovascular and Ablation Technologies Division, made of bovine tissue, has been geared to improve physicians' control and accuracy in valve placement. The valve has the unique ability to be completely re-sheathed (the process of bringing the valve back into the delivery catheter), repositioned at the implant site and retrieved before it is released from the delivery system. St. Jude has designed the Portico valve to overcome several key limitations associated with the first-generation transcatheter valves.
The target market for the Portico valve is the estimated 400,000 patients with severe aortic stenosis, considered to be at high-risk (or inoperable) for the legacy open-heart valve replacement surgery. The valve can be implanted using a transcatheter technique, rather than through open-heart surgery.
With several growth constraints in the mature legacy markets, medical devices makers are aiming to expand into the fast-growing emerging therapy areas. The TAVI market is emerging as a substantial new growth opportunity for the top-tier MedTech companies.
Although Edwards Lifesciences (EW) has the first mover advantage in the transcatheter heart valves market, Boston Scientific (BSX) is working to enter this high-growth market with its Lotus valves.
Edwards' Sapien transcatheter heart valve has already received the FDA approval for transfemoral delivery in Oct 2012. However, St. Jude does not expect revenues from the Portico line to increase significantly in 2013, due to a limited launch of only the 23 mm valve in Europe. The company currently carries a Zacks Rank #3 (Hold).