Boston Sci, Abbott gain European sign-off for stent products & services

With European regulatory approvals in hand, Boston Scientific ($BSX) and Abbott ($ABT) are both debuting stents or stent-related treatment offerings overseas that illustrate how rigorous competition in the space continues to be.

Following a CE mark earlier this year, BSX is rolling out its Innova Self-Expanding Bare Metal Stent System in Europe. The stent is designed to treat peripheral vascular lesions in the superficial femoral artery and proximal popliteal artery above the knee. BSX touts this product as a way to avoid other issues that happen when treating arteries above the knee, such as stent fractures and arteries closing back up again.

The stent doesn't have U.S. approval yet. But last month BSX launched enrollment in a major trial for the device, dubbed SuperNOVA, an international, 50-site effort to involve 300 patients where Innova will be tested in patients on both safety and effectiveness grounds. It is considered innovative in design and intended to give surgeons a better ability to place the stent accurately, with a way to boost blood flow and also be more durable.

Separately, Abbott is touting a new CE mark that enables use of dual anti-platelet therapy for at least three months after patients receive their Xience Prime and Xience V Everolimus eluting coronary stents for coronary artery disease. The treatment, known as DAPT for those into acronyms, combines aspirin and anti-platelet meds, which doctors typically give to patients after they receive their stents to help stop blood clots or other problems. Abbott celebrates this approval as something unique, as it offers the shortest period of treatment for a major drug eluting stent in Europe. Typical DAPT treatment recommendations in the EU range from 6 to 12 months, the company said.

Drug eluting stent sales have struggled in recent years after some studies questioned their relative safety and effectiveness to bare-metal stents. And regular, bare-metal stents are fairly ubiquitous now, so any way to stand out in the marketplace matters even more. BSX bills its new stent as a "next-generation" option with better precision and durability. Abbott gains a possible edge for its Xience Prime and Xience V stents by gaining approval of a blood-clotting treatment that doesn't have to last as long as what is used with competitors' stents. And Abbott sites clinical data from 10,000-plus patients who stopped the DAPT treatment after three months to back its case up.

Any market edge makes a difference, and it will be interesting to see if both companies successfully make their case that they do, indeed, stand out in the face of tremendous competition.

- read the Boston Scientific release
- check out Abbott's announcement

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