PRODUCTS & INNOVATION
With XIENCE Sierra, Abbott’s life-changing heart stent offers cardiologists a new level of care and precision.
Aug 24 2018
Percutaneous coronary intervention, or PCI, is a minimally-invasive heart procedure.
In the simplest, here’s how it works:
For the metal stent, it's a one-way journey.
Once in place, a stent is intended for long-term protection.
Complex PCI is what you would guess from its name: A high-degree of difficulty where a person has heavy hardening of the arteries (considered “calcified”), long or multiple blockages (also known as "lesions") or the need for multiple stents. More than 70 percent of cases fit some or all of this description.1
About those multiple stents that are there for the long term?
With a highly specialized coating that lowers the likelihood of the artery becoming re-blocked, our XIENCE stents have an unparalleled safety record2 from more than 100 clinical trials3 and 10 years of real-world experience. They're helping more than 8 million people worldwide live their best lives.4
And now, with XIENCE Sierra, our life-changing heart stent has taken another step forward. Thanks to Food and Drug Administration approval, this stent is now available to people suffering from complex cases of blocked arteries in the U.S. For interventional cardiologists and the people under their care, XIENCE Sierra brings unparalleled safety to even the most complex cases.
"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. "The updated design and improved deliverability mean doctors can access and unblock difficult-to-treat lesions with more flexibility and precision while having confidence in the outcomes and safety they expect from XIENCE."
XIENCE Sierra was approved in Europe in 2017 and recently received regulatory approval and reimbursement in Japan.
Javier Escaned, head of the International Cardiology Section at Hospital Clinico in San Carlos, Madrid, has first-hand experience with XIENCE Sierra.
"It was a reliable stent because it allowed me to perform a tough technique with a lot of ease," Dr. Escaned said. It was a stent that was able to face the challenges of having brisk changes in vessel diameter. It’s a very reassuring stent in the sense that we know that the long-term results with XIENCE are very good." very reassuring stent in the sense that we know that the long-term results with XIENCE are very good."
"With its unparalleled and well-known safety record, XIENCE Sierra is a critical part of our strategy to combat coronary artery disease," Brynelsen said. "But our strategy is not just a new stent. It's ensuring we provide technologies that help doctors optimally implant stents to give patients the best chances for good outcomes. Our diagnostic and imaging tools provide everything an interventional cardiologist needs to treat complex PCI."
You can read more about XIENCE stents here.
For U.S. Important Safety Information visit: https://www.xiencestent.com/us/#isi
1. Decision Resources Group, July 2017. Data on file at Abbott.
2. Palmerini, et al. XIENCE showed significant benefit compared to several DES and composite BMS in multiple large scale meta-analyses and other RCTs. The Lancet. 379:9824, 14-20 April 2012, pp. 1393-1402; Bangalore S, et al. Circ Cardiovasc Interv, Aug 6, 2013. doi: 10.1161/ Circinterventions.113.000415.; Valgimigli, et al. Effects of Cobalt-chromium Everolimus eluting or bare metal stent on fatal and non-fatal cardiovascular events. A patient-level meta analysis. EuroPCR 2014; Serruys, PW et al. RESOLUTE All Comers Trial, NEJM 2010. Published online June 16, 2010; Fajadet, J., et al. PLATINUM PLUS 30-day Poster, TCT 2012.
3. Data on file at Abbott.
4. 8 million people is based on data of 10,000,000 DES implants through Q1 2017.
IMPORTANT SAFETY INFORMATION
Caution: This product is intended for use by or under the direction of a physician. Prior to use, reference the Instructions for Use provided inside the product carton (when available), at eifu.abbottvascular.com or at medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and Adverse Events.
The XIENCE V®, XIENCE nano®, XIENCE PRIME®, XIENCE PRIME® LL, XIENCE Xpedition®, XIENCE Xpedition® SV and XIENCE Xpedition® LL, XIENCE Alpine®, and XIENCE SierraTM (XIENCE Family) of Everolimus Eluting Coronary Stents on the MULTILINK VISION® or MULTI-LINK MINI VISION® Delivery System
The XIENCE Sierra stent system is indicated for improving coronary artery luminal diameter in patients, including those with diabetes mellitus, with symptomatic heart disease due to de novo native coronary artery lesions (length £ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm. In addition, the XIENCE Sierra stent system is indicated for treating de novo chronic total coronary occlusions.
The XIENCE Sierra stent system is contraindicated for use in:
Patients with prior brachytherapy of the target lesion or the use of brachytherapy for treated site restenosis, patients in whom mechanical atherectomy devices or laser angioplasty catheters are used in conjunction with XIENCE Family stents, women who are pregnant or lactating, men intending to father children, pediatric patients, unresolved vessel thrombus at the lesion site, coronary artery reference vessel diameters < 2.25 mm or > 4.25 mm or lesion length > 32 mm, lesions located in saphenous vein grafts, unprotected left main coronary artery, ostial lesions, lesions located at a bifurcation or previously stented lesions, diffuse disease or poor flow (TIMI < 1) distal to the identified lesions, excessive tortuosity proximal to or within the lesion, recent Acute Myocardial Infarction (AMI) or evidence of thrombus in target vessel, multivessel disease, and in-stent restenosis.
POTENTIAL ADVERSE EVENTS
Adverse events (in alphabetical order) which may be associated with percutaneous coronary intervention treatment procedures and the use of a coronary stent in native coronary arteries include, but are not limited to, the following:
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