St. Jude Medical wins CE mark for TAVI tech

St. Jude Medical ($STJ) is leaping into the TAVI market overseas, backed by a newly-won CE mark for its Portico transcatheter aortic heart valve. The company will be far from the lone competitor in the space, however. Edwards Lifesciences' ($EW) Sapien valve leads the market for patients who can't have traditional open-heart procedures, and it already competes with Medtronic's ($MDT) CoreValve in Europe, with other rivals are on their way.

The European approval covers the 23mm Portico device as well as its delivery system, which is intended to work through the leg. Portico is designed for patients with severe aortic stenosis who can't have surgery, or are considered high risk for regular open-heart valve replacement surgery.

St. Jude billed the approval as "a key milestone" for its transcatheter heart valve, and claims the product as standing out because it can be brought back into the delivery catheter, repositioned or retrieved as needed.

That advantage may help in the long term, but rivals are already working hard to grab overseas market share. Medtronic has a CE mark for CoreValve but it doesn't reach patients whose vessels are too small for arterial implantation. The company also released new positive clinical data in Europe for Engager, a transcatheter heart valve made of bovine tissue leaflets and a self-expanding nitinol frame.

And then there is Sapien, the market leader, which stands out because it can also be implanted through the chest and reaches more high-risk patients as a result. In the U.S., the company recently won a major patent appeal against Medtronic regarding CoreValve, which creates an uncertain future for the product and shows that Edwards is willing to play hard to defend both its product and the market dominance it already has.

Meanwhile, all the competitors may have to compete with journal research such as a recent Belgian study that concludes transcatheter aortic valve implementation (TAVI) technology should only be used in a small number of cases where patients are deemed inoperable for technical reasons.

- read the release

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