Marlborough, Massachusetts-based Boston Scientific
Boston Scientific has now initiated a study of the company’s first fully resorbable drug-eluting scaffold system. The Fully Absorbable Scaffold Feasibility Study (FAST) is a prospective, single arm study designed to assess safety and performance of this next-generation scaffold for treatment of atherosclerotic coronary lesions.
An Open Source paper published in the journal Circulation entitled “Bioresorbable Scaffold – The Advent of a New Era in Percutaneous Coronary and Peripheral Revascularization?” (doi: 10.1161/CIRCULATIONAHA.110.971606″ by Yosinobu Onuma, MD, and Patrick W. Serruys, MD, PhD of the Erasmus Medical Center Thoraxcenter in Rotterdam, the Netherlands, suggests that Fully Bioresorbable Scaffold could be considered the “fourth revolution in interventional cardiology” and a “a huge leap forward in cardiovascular medicine” — an innovation of similar magnitude as advances like balloon angioplasty, bare metal stenting (BMS), and drug-eluting stents (DES).
Dr. Onuma is a leading expert in the field of bioresorbable scaffold. He also has extensive expertise in quantative coronary angiography (2-dimensional, 3-dimensional and bifurcation-dedicated), intravascular imaging, Syntax Score and metallic stents. Dr. Serruys is a professor and head of the Interventional Cardiology Department of the Thoraxcenter, and since 1980 has been Director of the Thoraxcenter’s Clinical Research Program of the Catheterization Laboratory, Drs. Onuma and Serruys cite several potential advantages Bioresorbable scaffolds have over current metallic DES technology, including:
• A reduction in adverse events such as ST because drug elution and scaffolding are temporary and are provided by the device only until the vessel has healed, and no foreign material can persist long term.
• Removal, through bioabsorption, of the rigid caging of the stented vessel.
• Reduction in bleeding complications, since once bioabsorption of the temporary scaffold has been completed, there will potentially be no requirement for long-term dual antiplatelet therapy.
• Improvement in future treatment options, eg: treatment of complex multivessel disease through use of multiple long DES.
• Allowing use of noninvasive imaging techniques such as computed tomography (CT) angiography or magnetic resonance imaging for follow-up. Currently, metallic stents can cause a blooming effect with these imaging modalities, making interpretation more difficult.
• As a reservoir for the local delivery of drugs and genes. Because the duration of bioresorption is modifiable, according to the type of polymers/copolymers, a tuned elution of multiple drugs can potentially be achievable.
• Elimination of the concern that some patients have at the thought of having an implant in their bodies for the rest of their lives.
The first patients in the FAST study have been enrolled by primary investigator and director Professor Ian Meredith, primary investigator and director of MonashHeart, at Monash Medical Centre in Melbourne, Australia. The study will enroll up to 30 patients.
Professor Meredith is currently a Professor of Cardiology for Monash University, Director of MonashHeart and Monash Health in Melbourne, Australia. He is also an Executive Director of the Monash Cardiovascular Research Centre, Monash Health. In 2012 Dr. Meredith was appointed a Member of the Order of Australia for his work as a clinician and a researcher in cardiology as well as his contributions as an advocate and advisor to the public health organisations.
“By virtue of its unique design properties, incorporating thinner struts and enabling greater stent expansion while maintaining radial strength, this fully resorbable scaffold technology may potentially overcome a number of limitations with first generation absorbable scaffolds,” says Professor Meredith in a Boston Scientific release.
The resorbable polymer scaffold incorporates several key design elements from the Boston Scientific SYNERGY Stent System, including a resorbable polymer and an ultrathin everolimus coating applied abluminally (on the exterior) to the scaffold. It also features a delivery system built with Boston Scientific expertise designed to facilitate improved acute performance.
“We are taking the best of our SYNERGY stent and applying it to our new, fully resorbable scaffold technology,” says Kevin Ballinger, president, Interventional Cardiology at Boston Scientific. “We continue to invest in meaningful innovations designed to provide better outcomes for patients with coronary artery disease.”
The Boston Scientific fully resorbable scaffold technology is currently classified an investigational device under development in the U.S. and Japan and is not available for sale in those countries. However, the SYNERGY Stent has CE mark approval and is available for sale in countries where CE mark is accepted.
Established in 1979 by John Abele and Pete Nicholas when its innovative steerable catheters were first used in less-invasive procedures, Boston Scientific subsequently launched the Promus Element drug-eluting coronary stent system; the S-ICD System which is the world’s first and only commercially available subcutaneous implantable defibrillator; the Alair Bronchial Thermplasty System fr treating asthma; and the Precision Plus Spinal Cord Stimulation System for treating chronic pain.
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