CardioMind Launches Trial Of Small Vessel, Drug-Eluting Stent
CardioMind has begun a First-in-Human clinical trial of its drug-eluting stent. The CARE II trial, as it is called, began in February at St. Vincent's Hospital in Melbourne, Australia, and, so far, has led to successful implantations in 12 patients.
With a .014-inch crossing profile, the CardioMind stent, known as the Sparrow Drug-Eluting Coronary Stent System, is 70% smaller in diameter than any other currently-approved stent. It targets treatment of blood vessels smaller than 2.75 mm in diameter, which currently constitute nearly 40% of all stent implants. The tightness of fit of conventional stents, as well as their inflexibility and the forces delivered by balloon expansion, however, may contribute to increased vessel trauma, which in turn leads to less favorable long term results. Beyond the range of current stenting practice, moreover, the CardioMind stent may also find use in vessels smaller than 2.25 mm and thus expand by up to 20% the worldwide market for stents, now over $4-billion annually.
"We view the Sparrow system as a platform technology for a gentler stent delivery system that will both improve safety and efficacy for currently performed procedures and also extend treatment to new areas of the coronary, neurovascular and peripheral artery system," says Charles Maroney, President and CEO of CardioMind.
How the CardioMind Stent Works
The unique design of the CardioMind Sparrow stent permits it to travel within the guidewire lumen to the site of the lesion. There the cardiologist releases the stent and allows it to self-expand to the vessel wall. By contrast, conventional balloon-expandable stents travel over guidewires to the lesion, and thus, by their very design, occupy more volume. The Sparrow stent also offers more flexibility than current stents, making it especially adaptable to treatment of the small, tortuous blood vessels often associated with diabetes.
To coat the Sparrow stent, CardioMind has licensed the rights to the SynBiosys biodegradable polymer system from SurModics. "The SynBiosys polymer allows the Sparrow stent to gradually return to a bare metal state, where we as an industry have 15 years of data showing no increase in late stent thrombosis," says Maroney.
The multi-site CARE II study, which will eventually enroll 220 patients, is a randomized trial of three different stents -- both bare-metal and drug-eluting versions of the Sparrow, plus a competitive stent.
According to Dr. Robert Whitbourn, associate professor and director of the Cardiovascular Research Center at St. Vincent's Hospital and one of the study's lead investigators: "Thus far, the first cases in this study are very encouraging. All our implanted patients are doing well, and I am impressed with the overall deliverability and performance of this new stent delivery system." Dr. Whitbourn expects to report first full follow-up results in eight months.
Overall, says Dr. Whitbourn, "The CardioMind Sparrow System represents a promising technology in interventional cardiology. The concept of a true guidewire-delivered stent opens up the possibilities of stenting in small vessels, branch vessels and other difficult-to-access vessels. It could, thus, expand the types of lesions in coronary artery disease that can be treated in more difficult patient populations."