CE Mark And EU Launch For Abbott’s XIENCE Xpedition™ “Extraordinarily Deliverable” Drug Stent

In short

Abbott has announced that the XIENCE Xpedition™ Everolimus Eluting Coronary Stent System has gained CE Mark approval for the treatment of coronary artery disease. The company is launching the product immediately in CE Mark countries.

Background

In a press release issued on August 20th, Abbott talks about how its XIENCE Xpedition features a new stent delivery system designed to optimise acute performance, particularly in challenging coronary anatomies. The company says its XIENCE Xpedition is supported by the robust clinical evidence of the XIENCE family of stents, including data from more than 45,000 patients across more than 100 studies with long-term outcomes out to five years.

Abbott says its XIENCE family of stents maintains one of the broadest ranges of CE Mark indications of drug eluting stents on the market in Europe. Specifically, XIENCE Xpedition has indications to treat patients with complex disease such as diabetes, as well as an indication for a minimum duration of three months of Dual Anti Platelet Therapy (DAPT) as we have covered on our pages before, here. This indication represents an important advantage, as three months of  DAPT is the shortest duration required for any major drug eluting stent offered in Europe. Long-term compliance to DAPT can be a challenge for patients and can lead to additional safety risks such as increased bleeding events. In addition, having a shorter DAPT duration after stent implantation may be beneficial in case a patient needs to interrupt or discontinue the medication prior to surgery or for other considerations.

XIENCE Xpedition is available in one of the broadest size matrices on the European market, with diameters ranging from 2.25 mm to 4 mm, including a unique 3.25 mm diameter, and lengths from 8 mm to 38 mm.

Clinician comments

“The extraordinary deliverability of the new XIENCE Xpedition drug eluting stent system allows physicians to treat particularly complex coronary disease with great ease and confidence,” said Evald H. Christiansen, M.D., Ph.D., interventional cardiologist, Department of Cardiology, Aarhus University Hospital, Skejby, Denmark, who treated the first patient with XIENCE Xpedition. “Supported by robust clinical evidence from the SPIRIT family of trials, and with a broad range of indications, XIENCE Xpedition is an important advancement in drug eluting stent technology.”

Company comments

“With XIENCE Xpedition’s excellent deliverability, broad size matrix and the option to discontinue or interrupt DAPT after three months, physicians in Europe now have a new, comprehensive offering to address the challenges of treating patients with complex coronary artery disease,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “With XIENCE Xpedition, Abbott continues its commitment to advancing drug eluting stent technology to improve product performance and patient outcomes.”

Regulatory status

XIENCE Xpedition is now available in Europe and other countries in Asia and the Middle East.

XIENCE Xpedition is an investigational device, limited by United States law to investigational use and is not approved or available for sale in the United States.

XIENCE PRIME® and XIENCE V® are available in the United States, Europe, the Middle East, Japan and most of Asia.

Source: Abbott Vascular, PR Newswire