Abbott reinforces global vascular leadership with new data on innovative technologies at ACC 2012

Abbott today announced the company’s schedule of key presentations at the American College of Cardiology’s (ACC) 61st Annual Scientific Session and i2 Summit 2012, to be held March 24 – 27 in Chicago. Presentations will include the following: data on patients at high surgical risk treated with the investigational MitraClip® system, an innovative catheter-based device for mitral valve repair; and two-year clinical results on the investigational Absorb™ bioresorbable vascular scaffold (BVS), a novel device designed to restore blood flow to the heart and then dissolve, leaving the patient with a vessel free of a permanent metallic implant. In addition, there will be a number of presentations on Abbott’s XIENCE V® Everolimus Eluting Coronary Stent System as well as preliminary results from a unique pilot program that screens women for cardiovascular risk factors at obstetrics/gynecology clinics.

“Abbott has achieved worldwide vascular leadership by developing innovative products to advance patient care, such as the XIENCE family of drug eluting stents. XIENCE is the world’s leading drug eluting stent and continues to gain market share in the U.S. and internationally – supported by a consistent stent design and solid clinical data from more than 100 clinical trials,” said Robert B. Hance, senior vice president, vascular, Abbott. “We continue to strengthen our leadership position with first-of-their-kind technologies such as the MitraClip system and the Absorb bioresorbable vascular scaffold – two devices with the potential to have a significant impact on patient care. We look forward to presenting new data for these important technologies at the upcoming ACC meeting.”

Key MitraClip system presentations are as follows (all times are Central):

• Survival in Patients with Moderate to Severe Mitral Regurgitation at High Risk for Surgery Treated with and without the MitraClip: A Propensity Matched Comparison − Sunday, March 25, from 9:30 a.m. to 10:30 a.m. in Hall A of McCormick Place South.
• EVEREST II High-Risk Cohort: Baseline Characteristics and One-Year Outcomes in Men vs. Women − Sunday, March 25, from 9:30 a.m. to 10:30 a.m. in Hall A of McCormick Place South.
• ACCESS EUROPE: A Post-Market Study of the MitraClip System for the Treatment of Significant Mitral Regurgitation in Europe: Analysis of Outcomes at Six Months − Sunday, March 25, from 10:45 a.m. to 11 a.m. in Room N427 of McCormick Place North.
• The Relationship Between the Magnitude of Reduction in Mitral Regurgitation Severity and Left Ventricular and Left Atrial Volumes Post-Treatment with the MitraClip Device − Sunday, March 25, from 11 a.m. to 11:15 a.m. in Room N427 of McCormick Place North.

In the United States, the MitraClip system is limited to investigational use only and is not available for sale. The MitraClip system is currently under review for approval by the U.S. Food and Drug Administration. The MitraClip system received CE Mark in 2008 and is authorized for sale in Europe and other international markets.

Key Absorb Bioresorbable Vascular Scaffold presentations are as follows (all times are Central):

• Evaluation of the Absorb BVS in the Treatment of Patients with de novo Native Coronary Artery Lesions: Two-Year Clinical Results of the ABSORB Cohort B Trial − Sunday, March 25, from noon to 12:10 p.m. in Room S106b of McCormick Place South.
• First Sequential Assessment at Six Months and Two Years of the Second Generation Absorb Everolimus-Eluting Bioresorbable Scaffold: A Multi-Imaging Modality Study − Sunday, March 25, from 11:25 a.m. to 11:35 a.m. in Room S106b of McCormick Place South.
• Vascular Response of the Segments Adjacent to the Proximal and Distal Edges of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold: Six Months and One Year Follow-Up Assessment − Sunday, March 25, from 11:45 a.m. to 11:55 a.m. in Room S106b of McCormick Place South.

In the United States, Absorb is an investigational device and is not available for sale. Absorb has CE Mark and is authorized for sale in Europe.

Women’s Heart Health Initiative: Preliminary results from a novel pilot program to screen women for cardiovascular risk factors in obstetrics and gynecology clinics will be presented on Sunday, March 25, from 11 a.m. to noon in Hall A of McCormick Place South. The pilot program, supported by Abbott’s Women’s Heart Health Initiative (WHHI) in partnership with the Society for Cardiovascular Angiography and Interventions (SCAI) – Women in Innovations program, is designed to address the referral gap between obstetrician/gynecologists and cardiologists, with the goal of early detection of heart disease in women.

About XIENCE PRIME and XIENCE V

XIENCE PRIME received CE Mark in 2009 and FDA approval in 2011, and 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.

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 4.2 mm. Additional information about XIENCE V, including important safety information, is available at www.xiencestent.com or http://www.abbottvascular.com/static/cms_workspace/pdf/ifu/coronary_intervention/XIENCE_V_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 vascular devices. Everolimus has been shown to inhibit in-stent neointimal growth in the coronary vessels following stent implantation, due to its anti-proliferative properties.

About the MitraClip Technology and Procedure

The percutaneous MitraClip system is designed to treat significant mitral regurgitation (MR) and to safely provide sustained clinical and quality-of-life benefits for patients suffering from the debilitating symptoms of MR.

The MitraClip system is designed to reduce significant MR by clipping together the leaflets of the mitral valve, one of the four valves of the heart. The catheter-based device is delivered to the heart through the femoral vein, a blood vessel in the leg. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. The safety and efficacy of the MitraClip system were studied in the EVEREST II randomized clinical trial.

The MitraClip system is an investigational device currently under review for approval by the U.S. Food and Drug Administration. The device received CE Mark in 2008 and is authorized for sale in more than 25 countries.

About the Absorb Bioresorbable Vascular Scaffold

Absorb is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolvable sutures. Studies to date suggest that the Absorb device restores blood flow by opening a blocked vessel and providing support to the vessel until the device dissolves after approximately two years. In the United States, Absorb currently is investigational and is not available for sale. Absorb has CE Mark and is authorized for sale in Europe for the treatment of coronary artery disease.

Abbott has completed the first stage of one clinical trial called ABSORB and currently is conducting the second stage of the trial as well as two additional trials − ABSORB EXTEND and ABSORB II − to evaluate the company’s bioresorbable device for the treatment of coronary artery disease.