Medical devices major
St. Jude Medical Inc.
) 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
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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
) 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
) has the first mover advantage in the transcatheter heart valves
) is working to enter this high-growth market with its Lotus
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).