Cardiovascular Systems Reports Two-Year Data Showing Durable Outcomes in Patients Treated with Diamondback 360° Pad System
September 22 2009 - 11:00AM
Business Wire
Two-year follow-up of patients in the first-ever prospective,
multi-center clinical trial evaluating a plaque removal product
show promising results after treatment with the Diamondback 360®
PAD System, a minimally invasive catheter system that removes
hardened plaque to restore blood flow in arteries. Dr. Barry
Weinstock, Mid-Florida Cardiovascular Specialists, Orlando, Fla.,
will present the data from the OASIS follow-up study in a Tuesday,
September 22 poster session (No. 578, Hall D), from 8 a.m. to 10
a.m. PT, at the 21st annual Transcatheter Cardiovascular
Therapeutics (TCT) scientific symposium in San Francisco, sponsored
by the Cardiovascular Research Foundation.
In patients with peripheral arterial disease (PAD), plaque that
accumulates in leg or foot arteries reduces blood flow and leads to
leg pain, immobility and potentially amputation. In the United
States alone, as many as 12 million patients suffer from PAD.
Cardiovascular Systems, Inc., (CSI) (Nasdaq: CSII) provides
comprehensive solutions for treating PAD, including the Diamondback
360°.
“At CSI, we are committed to clinical studies that provide
scientifically sound long-term data to help physicians evaluate
therapies and better treat PAD patients,” said David L. Martin,
president and chief executive officer. “The two-year follow-up
of patients from our landmark OASIS clinical trial reinforces our
excitement about treatment with the Diamondback 360°, its ability
to help save legs and lives, and restore quality of life for
patients and their families. Further, in this cost-conscious
healthcare environment, we are mindful of the economic benefits of
keeping PAD patients mobile and independent. Additional clinical
studies of the Diamondback 360° are under way to further enhance
our understanding of our product.”
“Our goal is to treat PAD patients, restore their ability to
walk pain-free and keep their legs for life,” said Dr. Weinstock.
“This two-year data of OASIS patients adds to our confidence in the
safety and efficacy of the Diamondback 360°, and further encourages
me to use the device as a first option in treating this prevalent
disease.”
The OASIS study (Orbital
Atherectomy System for the Treatment of
Peripheral Vascular
Stenosis), a non-randomized,
IDE study, demonstrated the safety and efficacy of the Diamondback
360° in treating 124 patients with PAD with follow-up out to six
months. The primary endpoints were met with a 59-percent reduction
in stenosis in the 201 lesions treated and a 4-percent rate of
device-related serious adverse events. No patients had major
amputations, and ankle-brachial index (ABI) scores remained
significantly improved (p
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