Friday, December 10, 2010

BWI: Indian Heart Patient is First Patient in Asia Treated with Abbott's Groundbreaking Bioresorbable Vascular Scaffold

Press release from Business Wire India
Source: Abbott Vascular
Friday, December 10, 2010 03:24 PM IST (09:54 AM GMT)
Editors: General: Consumer interest; Business: Advertising, PR & marketing, Business services, Healthcare, biotechnology & pharmaceutical; Healthcare
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Indian Heart Patient is First Patient in Asia Treated with Abbott's Groundbreaking Bioresorbable Vascular Scaffold
Dr. Ashok Seth of Fortis-Escorts Heart Institute Successfully Treated the First Patient in Asia with Revolutionary Device to Treat Coronary Artery Disease

New Delhi, Delhi, India, Friday, December 10, 2010 -- (Business Wire India) -- The first heart disease patient in India has been successfully treated with the bioresorbable vascular scaffold (BVS). Abbott's BVS is a groundbreaking device designed to restore blood flow by opening a clogged vessel and providing support while it heals. Once the vessel can remain open without the extra support, the bioresorbable scaffold is designed to be slowly metabolized and eventually dissolve and disappear from the body. The patient, treated by Dr. Ashok Seth, Chairman, Cardiovascular Sciences at Fortis-Escorts Heart Institute in New Delhi, is the first in the Asia region to receive this device.

"Treatments for coronary artery disease have come a long way from the days of balloon angioplasties and metal stents. The results from Abbott's earlier ABSORB trial were quite remarkable, and physicians are intrigued by the concept of being able to effectively open up and support a blocked artery without leaving a permanent implant behind in the blood vessel," said Dr. Seth. "Abbott's BVS has the potential to revolutionize how we treat patients with coronary artery disease because there is no permanent metal implant, once the BVS is resorbed by the body, natural vessel function may be restored" said Dr Seth.

Heart disease affects more than 60 million people in India but less than 300000 people with coronary artery disease undergo procedures such as Percutaneous Coronary Intervention and Coronary artery bypass surgery.

Fortis-Escorts is the first hospital in India, and the first in Asia, to enroll a patient into the ABSORB EXTEND trial, a worldwide trial of up to 1,000 patients at 100 centers in Europe, Asia Pacific, Canada and Latin America. To date, approximately 200 patients have been implanted with the device, and data has been presented on patients at various time intervals, including 30 patients out to four years. Five other Indian hospitals will participate in the trial: SGPGI Hospital in Lucknow, SAL Hospital in Ahmedabad, Care Hospital in Hyderabad, Apollo Hospital in Chennai, and Madras Medical Mission in Chennai.

"Bringing the ABSORB EXTEND trial to India reinforces Abbott's commitment to research and develop innovative devices for the treatment of patients with vascular disease," said Amit Kumar, Regional Director and General Manager, Abbott Vascular, South Asia and South East Asia. "The BVS promises to be an important next step in the treatment of coronary artery disease, and Abbott is committed to making this revolutionary technology a clinical reality."

Abbott is the only company with long-term clinical data evaluating the safety and performance of a fully bioresorbable drug eluting vascular scaffold. Results from the first stage of the ABSORB trial with 30 patients demonstrated that Abbott's BVS successfully treated coronary artery disease and was resorbed into the walls of the treated arteries. Patients in this first phase of the ABSORB trial experienced no stent thrombosis (blood clots) out to four years and no new major adverse cardiac events (MACE¹). The treated vessels were able to expand and contract, without being restricted by a permanent implant - indicating that the device was resorbed.

Abbott's BVS, which is under clinical investigation in Europe, Australia, New Zealand and now in India, is not currently available for sale anywhere in the world.

The device is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolving sutures. Since a permanent implant is not left behind, a vessel treated with a BVS ultimately may have the ability to move, flex and pulsate similar to an untreated vessel. The potential to restore these naturally occurring vessel functions, or vascular restoration, is one of the features that will make Abbott's BVS unique in the treatment of coronary artery disease.

About the ABSORB EXTEND Clinical Trial

The ABSORB EXTEND trial is a large-scale, single-arm trial that will enroll approximately 1,000 patients from up to 100 centers in Europe, Asia Pacific, Canada and Latin America. The ABSORB EXTEND trial will enroll patients with more complex coronary artery disease and will provide data that will be used to support approval in various markets around the world. Key endpoints of the study include - MACE and treated site thrombosis rates - at 30 days; six, 12, 24 and 36 months, as well as an assessment of the acute performance of the bioresorbable vascular scaffold, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities.

Abbott's bioresorbable technology delivers everolimus, an anti-proliferative drug. Everolimus is developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit treated site neointimal growth in the coronary vessels following vascular device implantation, due to its anti-proliferative properties.

About Abbott Vascular

Abbott Vascular is a global leader in cardiac and vascular care with market leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.

About Abbott

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries. Abbott has been operating in India for more than a century and employs 10,000 people throughout the country. Abbott has commercial locations in New Delhi, Mumbai, Vadodara and Gurgaon, manufacturing facilities in Goa and Baddi, and is headquartered in Mumbai. Abbott's news releases and other information are available on the company's Web site at www.abbott.com.


CONTACT DETAILS
Jonathon Hamilton, Abbott Vascular, +1 (408) 845-3491
Kavita Bhaskaran, Sampark Public Relations, +91 9810439897

KEYWORDS
CONSUMER, MARKETING, BUSINESS SERVICES, HEALTHCARE, HEALTHCARE

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