FDA News

New iteration of EES receives FDA approval

Samin Sharma
Samin Sharma

Abbott announced that a new generation of an everolimus-eluting coronary stent system for treatment of patients with complex blockages associated with CAD has received approval from the FDA.

Compared with prior generations, the coronary stent system (Xience Sierra, Abbott) has a thinner profile, longer lengths, increased flexibility and small diameters to access multiple or totally blocked vessels in patients, according to a press release from the company.

“This technology of the newer DES has done very well and is making more and more improvements than the previous generation,” Samin Sharma, MD, director of clinical and interventional cardiology at Mount Sinai Hospital and a member of the Cardiology Today’s Intervention Editorial Board, said in an interview. “It’s not anything revolutionary or something new, but it is an addition to what is existing in our armamentarium. You need a stent that can go anywhere you want.”

Previous studies have shown that the device has low rates of complications and is safe in patients with complex blockages, which accounts for up to 70% of cases, according to the release.

Since the first version of the EES received initial regulatory approval in 2006 in the European Union and 2008 in the U.S., more than 8 million people have received the stent, according to the release.

"We developed Xience Sierra so that physicians can more easily deliver the stent even in challenging cases," said Chuck Brynelsen, senior vice president of Abbott's vascular business, said in the release. "The updated design and improved deliverability mean doctors can access and unblock difficult-to-treat lesions with more flexibility and precision than other stents."

“What all this means is that it’s dependable and makes the procedure simpler for the interventionalist and faster, and secondly, it will cause less side branch occlusion,” Sharma said in an interview. – by Darlene Dobkowski

For more information:

Samin Sharma, MD, can be reached at samin.sharma@mountsinai.org.

Disclosures: Sharma reports he is on the speaker’s bureau for Abbott, Boston Scientific and Cardiovascular Systems Inc. Brynelsen is an employee of Abbott.

Samin Sharma
Samin Sharma

Abbott announced that a new generation of an everolimus-eluting coronary stent system for treatment of patients with complex blockages associated with CAD has received approval from the FDA.

Compared with prior generations, the coronary stent system (Xience Sierra, Abbott) has a thinner profile, longer lengths, increased flexibility and small diameters to access multiple or totally blocked vessels in patients, according to a press release from the company.

“This technology of the newer DES has done very well and is making more and more improvements than the previous generation,” Samin Sharma, MD, director of clinical and interventional cardiology at Mount Sinai Hospital and a member of the Cardiology Today’s Intervention Editorial Board, said in an interview. “It’s not anything revolutionary or something new, but it is an addition to what is existing in our armamentarium. You need a stent that can go anywhere you want.”

Previous studies have shown that the device has low rates of complications and is safe in patients with complex blockages, which accounts for up to 70% of cases, according to the release.

Since the first version of the EES received initial regulatory approval in 2006 in the European Union and 2008 in the U.S., more than 8 million people have received the stent, according to the release.

"We developed Xience Sierra so that physicians can more easily deliver the stent even in challenging cases," said Chuck Brynelsen, senior vice president of Abbott's vascular business, said in the release. "The updated design and improved deliverability mean doctors can access and unblock difficult-to-treat lesions with more flexibility and precision than other stents."

“What all this means is that it’s dependable and makes the procedure simpler for the interventionalist and faster, and secondly, it will cause less side branch occlusion,” Sharma said in an interview. – by Darlene Dobkowski

For more information:

Samin Sharma, MD, can be reached at samin.sharma@mountsinai.org.

Disclosures: Sharma reports he is on the speaker’s bureau for Abbott, Boston Scientific and Cardiovascular Systems Inc. Brynelsen is an employee of Abbott.