Biosensors International Group, Ltd ("Biosensors", "Company", BIG:SP) announced 8-month results from the CARE II Study, which showed that its novel Sparrow® drug-eluting stent system, developed by recently-acquired CardioMind, Inc., is both safe and effective in the treatment of small vessel lesions. These results were presented by the Principal Investigator, Dr. Alexandre Abizaid, Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil, at the 22nd annual Transcatheter Cardiovascular Therapeutics ("TCT") scientific symposium, sponsored by the Cardiovascular Research Foundation.

The Sparrow drug-eluting stent system combines a limus drug in a fully biodegradable polymer matrix with a self-expanding ultra-thin nitinol stent, mounted within a 0.014-inch guidewire delivery system. Due to its unique "stent-on-the-wire" construction, Sparrow has been developed as the smallest profile drug-eluting stent system in the world, 60% smaller than the nearest available coronary stent system. Stent deployment is achieved through a novel release mechanism which utilizes electrochemical dissolution.

The CARE II trial included 138 patients with single de novo native coronary artery lesions with a diameters between 2.00 mm and 2.75 mm and lengths up to 20 mm, randomized to receive either the Sparrow limus-eluting stent (DES), Sparrow bare-metal stent equivalent (BMS), or the established MicroDriver® BMS designed for small vessel use. The trial's primary endpoint was in-stent late loss at eight months. In-stent late loss is defined as the amount of tissue that builds up inside the stent after stent implantation and has long been considered a primary measure of device effectiveness.

Average in-stent late loss in patients treated with the Sparrow DES was 0.29 mm, compared with 0.86 mm in patients treated with the Sparrow BMS, and 0.99 mm in patients treated with the MicroDriver. The difference was statistically significant in both cases (Sparrow DES vs. Sparrow BMS: p=0.0001; Sparrow DES vs. MicroDriver: p