Life Sciences Insight

Abbott racks up 2 more U.S., EU approvals for Xience family of drug-eluting stents

They say if it ain’t broke, don’t fix it, but Abbott just can’t seem to resist making regular additions to its longstanding line of Xience stents.

The product family received its first regulatory approval from the FDA in 2008 and has been granted dozens more in the years since, covering new versions of the dug-eluting stent and new indications for existing versions.

Most recently, Abbott tacked on two more approvals—one in each of those categories—in both the U.S. and Europe.

The first clears the latest addition to the Xience line, the Skypoint stent. With an FDA approval and CE mark in hand, the Skypoint can now be used to hold open blocked coronary arteries in patients with diabetes, heart disease and chronic total coronary occlusion.

The Skypoint model improves on the design of past Xience stents with a slimmer catheter, one-piece shaft and larger expansion capabilities that make it easier for physicians to place the stent inside a blood vessel and also allow the stent to be placed inside larger arteries than previous entrants.

Like its predecessors, once placed, the Skypoint stent slowly releases the chemotherapy drug everolimus to prevent blood clots from forming within the stent and causing future blockages.

The other FDA approval and CE mark, meanwhile, were granted to the entire Xience family. The line has been cleared for use with a regimen of dual antiplatelet therapy lasting as short as 28 days for patients with a high bleeding risk, marking the shortest usage of blood thinners for any drug-eluting stent.

Typically, after a stent is implanted, patients must undergo dual antiplatelet therapy, or DAPT, to prevent the formation of blood clots in the vessel. Though this therapy is administered to prevent heart attacks and even death, it also raises the risk of bleeding complications in about 20% of all stent recipients.

Because the risk of side effects increases the longer a high-risk patient undergoes antiplatelet therapy—with most regimens lasting from six months to a year—the new month-long indication for Abbott’s Xience stents aims to strike a balance between stopping clotting while also preventing further complications.

A clinical study compared 28-day and six-month regimens of the therapy in patients implanted with Xience stents reinforced the shorter regimen’s ability to achieve that balance. The one-month group of patients saw significantly lower rates of severe bleeding and no increases in stent thrombosis or ischemic events, as well as heart attacks or death.

“The new FDA approval for DAPT for the Xience family of stents provides interventional cardiologists confidence they are delivering the best care to patients with high bleeding risk. A short DAPT duration minimizes risks for high bleeding risk patients and allows them to return to daily life sooner and with more assurance,” said the study’s principal investigator, Roxana Mehran, director of interventional cardiovascular research at Icahn School of Medicine at Mount Sinai.

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