SUNNYVALE, Calif., March 31 /PRNewswire/ -- CardioMind, Inc., a
developer of stents for small, difficult-to-treat blood vessels, announced
today that it 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(TM) 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(TM) biodegradable polymer system from SurModics, Inc. (Nasdaq:
SRDX). "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
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."
By reaching its First-in-Human milestone, CardioMind triggered the
second tranche closing of a $33-million venture capital round raised in
June 2007. That round, CardioMind's third since it was founded in 2003,
included an initial $11-million for research and development and the
just-released $22-million for completion of the CARE II Study and further
development. Co-leaders of the round were SV Life Sciences and De Novo
Ventures, with additional funding coming from existing investors InterWest
Partners, Latterell Venture Partners, Morgenthaler Ventures, and Onset
CardioMind is a developer of a unique stent delivery platform that
allows interventionalists to treat very small blood vessels of 2.75
mm-diameter and less. Such vessels, often tortuous, have proven especially
vulnerable to injury from conventional stent delivery systems. The small
crossing profile and flexibility of the CardioMind platform promise to
increase both stent safety and efficacy in such vessels and to extend the
range of vessels in which stents can be deployed throughout the coronary,
neurovascular and peripheral artery systems.
SOURCE CardioMind, Inc.