FAST Enrollment Begins for Boston Scientific's Fully Resorbable Drug-Eluting Scaffold

July 20, 2015—Boston Scientific Corporation has initiated the Fully Absorbable Scaffold Feasibility Study (FAST) of the company’s first fully resorbable drug-eluting scaffold system. FAST is a prospective, single-arm study designed to assess the safety and performance of this next-generation scaffold for the treatment of atherosclerotic coronary lesions. The study will enroll up to 30 patients. 

FAST primary investigator Prof. Ian Meredith, MD, enrolled the first patients in the study. Prof. Meredith is Director of MonashHeart at Monash Medical Center in Melbourne, Australia.

In the company’s press release, Prof. Meredith commented, “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.”

According to Boston Scientific, 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 that is applied abluminally to the scaffold. It also features a delivery system designed to facilitate improved acute performance.

The company advised that the Boston Scientific fully resorbable scaffold technology is under development and is not available for sale.

The Synergy stent is an investigational device and not available for sale in the United States and Japan and is not available for sale in those countries. The Synergy stent has received European CE Mark approval and is available for sale in countries where CE Mark is accepted.