Abbott to present new data for key vascular products at TCT 2011

Abbott today announced the company’s schedule of key data presentations at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, to be held Nov. 7 – 11 in San Francisco. New data will be presented on two of Abbott’s key investigational products: the MitraClip® system and the ABSORB™ bioresorbable vascular scaffold (BVS). One-year data for the XIENCE PRIME™ Everolimus Eluting Coronary Stent System, recently approved by the U.S. Food and Drug Administration (FDA), will also be presented. In addition, long-term data will be presented from the SPIRIT III and SPIRIT IV trials comparing Abbott’s XIENCE V® Everolimus Eluting Coronary Stent System to the TAXUS® Express Paclitaxel-Eluting Coronary Stent System.

“Innovation drives our business and we look forward to new data at TCT for the advanced technologies we are developing to improve patient care, such as the MitraClip system and the ABSORB bioresorbable scaffold,” said Robert B. Hance, senior vice president, vascular, Abbott. “In addition, data will be presented on our next-generation XIENCE PRIME stent, which incorporates the best of our XIENCE technology with design enhancements for use in treating challenging lesions, making it an important addition to our XIENCE family of drug eluting stents.”

Key presentations are as follows (all times are Pacific):

The MitraClip System

Several TCT presentations will discuss the MitraClip system, a catheter-based device for mitral valve repair. The following poster presentations on Tuesday, Nov. 8, from 8 – 10 a.m., in Hall D, will present results for the MitraClip system in patients at high risk for mitral valve surgery:

• Data for the MitraClip therapy in high surgical risk patients with residual mitral regurgitation (MR) grade of 2+ or less one year following device treatment.
• Data for the MitraClip therapy in high surgical risk patients with MR of functional etiology.

In addition, an oral presentation on the use of MitraClip therapy in high surgical risk patients with MR of degenerative etiology, as well as a number of additional discussions related to the MitraClip system, will take place during the “Valvular Heart Disease Summit: Mitral Valve Therapies” on Tuesday, Nov. 8, from 1- 6 p.m., in Room 134.

The MitraClip system received CE Mark in March 2008. In the U.S., the MitraClip system is an investigational device, limited by federal law to investigational use only and is not available for sale. The MitraClip system is currently under review for approval by the FDA.

ABSORB BVS

Eighteen-month data on 101 patients from the second phase of the ABSORB clinical trial will be presented on Tuesday, Nov. 8, at 11:28 a.m., in Room 111. The ABSORB trial is evaluating Abbott’s ABSORB BVS, which is in development for the treatment of coronary artery disease. Studies have shown that ABSORB restores blood flow by opening a clogged vessel and providing support to the vessel until the device dissolves within approximately two years, leaving patients with a treated vessel free of a permanent metallic implant.

Additional data on ABSORB will be presented in a number of data presentations during the TCT conference. Abbott announced that the device received CE Mark in January 2011. The device is investigational and not approved or available for sale in the U.S.

XIENCE

XIENCE, which has been studied in more than 40,000 patients worldwide, will be featured in a number of data presentations during the TCT conference. In addition to long-term follow-up data from the XIENCE V USA trial, a large, prospective, multi-center study of XIENCE V in 4,382 real-world patients, the following XIENCE data will be presented.

• SPIRIT PRIME: One-year outcomes from the SPIRIT PRIME trial will be presented on Tuesday, Nov. 8, at 11:46 a.m., in Room 125. SPIRIT PRIME is a prospective, multi-center, non-randomized trial designed to study XIENCE PRIME in 500 U.S. and international patients. XIENCE PRIME offers an advanced stent design and a delivery system designed for excellent flexibility and enhanced deliverability, with a broad size matrix that includes long lengths up to 38 mm. XIENCE PRIME received CE Mark in June 2009 and FDA approval in November 2011.
• SPIRIT III: Five-year results from the SPIRIT III trial will be presented on Tuesday, Nov. 8, at 10:15 a.m., in Room 111. SPIRIT III is a prospective, multi-center, randomized, single-blind, controlled clinical trial comparing XIENCE V to TAXUS in 1,002 patients (669 XIENCE V patients and 333 TAXUS patients) with either one or two de novo coronary artery lesions.
• SPIRIT IV: Three-year results from the SPIRIT IV trial will be presented on Tuesday, Nov. 8, at 11:07 a.m., in Room 111. SPIRIT IV is one of the largest randomized clinical trials ever conducted that compares two drug eluting stents – XIENCE V and TAXUS.

About XIENCE V and XIENCE PRIME

Abbott’s market-leading XIENCE V drug eluting stent is marketed in the U.S., Europe, Japan and other international markets.

XIENCE V is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions ≤28 mm) with reference vessel diameters of 2.25 mm to 4.25 mm. Additional information about XIENCE V, including important safety information, is available at http://www.abbottvascular.com/us/xience-v.html or http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/XIENCE_V_Everolimus_Eluting_Coronary_Stent_System.pdf.

XIENCE PRIME received CE Mark in 2009. With recent FDA approval, XIENCE PRIME is now available in the U.S., Europe, the Middle East and most of Asia.

XIENCE PRIME is indicated for improving coronary artery luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (lesions ≤32 mm) with reference vessel diameters of ≥2.25 mm to ≤4.25 mm. Additional information about XIENCE PRIME, including important safety information, is available at www.xiencestent.com or http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/XIENCE_PRIME_Everolimus_Eluting_Coronary_Stent_System.pdf.

Everolimus, developed by Novartis Pharma AG, is a proliferation signal inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.