Cardiovascular Systems Receives FDA Approval to Complete Patient Enrollment in ORBIT II Coronary Clinical Trial
May 24 2011 - 8:00AM
Business Wire
Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII) has received
FDA approval to complete enrollment of 429 patients in its ORBIT II
Investigational Device Exemption (IDE) clinical trial for a
coronary application for its Diamondback 360® System. The approval
came following FDA review of data from the first 50 cases, as
called for in the trial protocol. The ORBIT II trial is evaluating
the safety and effectiveness of CSI’s orbital technology in
treating calcified coronary arteries. CSI has also received
conditional approval from the FDA to use ViperSlide® Lubricant in
the ORBIT II study.
“Approval to proceed with ORBIT II patient enrollment is a major
milestone in obtaining a U.S. regulatory approval for a coronary
application – a significant market opportunity for CSI,” said David
L. Martin, president and CEO of Cardiovascular Systems. “The
Diamondback 360°’s orbital mechanism of action has already
demonstrated it is especially well suited for treating small,
calcified lesions in leg arteries. Use of the Diamondback 360°
device in small, calcified coronary arteries may facilitate more
effective stent placement, or avoid the trauma and cost of heart
bypass surgery. This was demonstrated by the strong safety and
efficacy data from our ORBIT I coronary feasibility trial, and we
are confident we will have similar results in ORBIT II.”
The Diamondback 360° is designed to be well suited for removing
calcific and fibrocalcific plaque in coronary lesions. The system
uses a diamond-coated crown with a unique orbital mechanism of
action to sand and remove hardened plaque, which may facilitate
more effective stent placement and restoration of blood flow in the
coronary arteries. The orbital action also allows continuous saline
and blood flow through the lesion, which may be advantageous during
treatment. CSI’s proven orbital mechanism action protects healthy
vessel tissue while removing even the most difficult plaque to
treat.
CSI received unconditional FDA IDE approval for the ORBIT II
study in April 2010. As many as 50 U.S. medical centers are
expected to participate in ORBIT II. Dr. Jeffrey Chambers, an
interventional cardiologist with Metropolitan Cardiovascular
Consultants, Minneapolis, is the principal investigator for the
ORBIT II study. In the initial ORBIT I coronary study of 50
patients in India, the Diamondback 360⁰ was successful in 98
percent of patients, with an acute procedural success rate of 94
percent. As part of its 360⁰ Clinical Series, CSI has completed
enrollment in 11 peripheral and coronary studies at nearly 300
hospitals with more than 2,400 patients.
Safe Harbor
Certain statements in this news release are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 and are intended to enjoy the protection of the
safe harbor for forward-looking statements provided by that Act.
For example, statements in this press release regarding (i) the
number of patients and centers that will be involved in the ORBIT
II trial; (ii) FDA approval to use the ViperSlide® Lubricant in the
ORBIT II study; (iii) CSI’s progress toward U.S. regulatory
approval for a coronary application; (iv) the market opportunity of
the coronary application; (v) CSI’s ability to repeat the outcomes
of the ORBIT I trial in the ORBIT II trial; and (vi) the
effectiveness of the Diamondback 360°, are forward-looking
statements. These statements involve risks and uncertainties which
could cause results to differ materially from those projected,
including but not limited to the potential for unanticipated delays
in enrolling medical centers and patients for studies; the FDA
process; new data or events that may disrupt plans for these
studies; unexpected results or clinical outcomes in the ORBIT II
trial and other factors detailed from time to time in CSI’s SEC
reports, including its most recent annual report on Form 10-K. CSI
encourages you to consider all of these risks, uncertainties and
other factors carefully in evaluating the forward-looking
statements contained in this release. As a result of these matters,
changes in facts, assumptions not being realized or other
circumstances, CSI's actual results may differ materially from the
expected results discussed in the forward-looking statements
contained in this release. The forward-looking statements made in
this release are made only as of the date of this release, and CSI
undertakes no obligation to update them to reflect subsequent
events or circumstances.
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a
medical device company focused on developing and commercializing
innovative solutions for treating vascular and coronary disease.
The company’s Stealth 360°™, Diamondback 360® and Diamondback
Predator 360® Orbital PAD Systems treat calcified and fibrotic
plaque in arterial vessels throughout the leg in a few minutes of
treatment time, and address many of the limitations associated with
existing surgical, catheter and pharmacological treatment
alternatives. The U.S. FDA granted 510(k) clearance for the use of
the Diamondback 360° in August 2007 and for the Stealth 360° in
March 2011. To date, more than 37,000 PAD procedures have been
performed using the Diamondback 360° in leading institutions across
the United States.
For more information, visit the company’s website at
www.csi360.com.
Product Disclosure
The Stealth 360°™, Diamondback 360® and Diamondback Predator
360® Orbital PAD Systems are percutaneous orbital atherectomy
systems indicated for use as therapy in patients with occlusive
atherosclerotic disease in peripheral arteries and stenotic
material from artificial arteriovenous dialysis fistulae. The
systems are contraindicated for use in coronary arteries, bypass
grafts, stents or where thrombus or dissections are present.
Although the incidence of adverse events is rare, potential events
that can occur with atherectomy include: pain, hypotension,
CVA/TIA, death, dissection, perforation, distal embolization,
thrombus formation, hematuria, abrupt or acute vessel closure, or
arterial spasm.
The Diamondback 360® System for use in coronary arteries is an
investigational device and is limited by Federal (or United States)
law to investigational use.
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