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FDA approves Xience Xpedition DES
Abbott has announced today the FDA approval of its Xience Xpedition everolimus-eluting coronary stent system and the immediate launch of the device in the United States.
The Xience Xpedition stent has a new stent delivery system that optimizes deliverability, particularly in challenging coronary anatomies, and features the largest size matrix in the US market, according to a company-issued press release. It will be available in diameters ranging from 2.25 mm to 4 mm, including a 3.25 mm diameter, lengths from 8 mm to 38 mm, and with both rapid exchange and over-the-wire configurations. Currently, the Xience drug-eluting stents are the first and only DES in the US market to be proven safe for direct stenting, which allows the stent system to be delivered without needing another device to prepare the lesion.
Samin K. Sharma
“Xience Xpedition represents a powerful combination of deliverability, strong clinical data and broad availability of meaningful sizes — three factors that make this product well-suited to treat a wide range of patients,” Samin K. Sharma, MD, with Mount Sinai Medical Center, New York, who was the first physician to implant the device in the United States, said in the release. “The impact of the changes to the stent delivery system is particularly notable in patients with complex coronary anatomy. For these patients, physicians have a new technology to reach the blockage and restore blood flow with ease and confidence.”
The Xience Xpedition stent is indicated for patients with symptomatic heart disease due to de novo native coronary artery lesions with reference vessel diameters of 2.25 mm to 4.25 mm. In addition to the United States, the stent is available in the Europe, the Middle East and parts of Asia.
Perspective
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Now that we have much longer stents, like Xpedition, it's nice to be able to do with one stent what we had to do with two stents before. That is important for a number of reasons. First and foremost, stent thrombosis rates are probably reduced if you use one long stent as opposed to multiple, overlapping stents. The second advantage is deliverability. It's hard to compare the deliverability across platforms because we are not doing head-to-head comparisons. That being said, the feel of the device — as I've had the chance to use it several times including for STEMI purposes — is very different compared with the Xience V or Prime; it's a lot more pushable. You can tell immediately that the product was designed to improve force transfer in a way that would enhance pushability. I suspect as a result of the enhanced deliverability it will be much easier to get this stent into tortuous vessels.