Cardiovascular Systems’ Predator 360° Data Demonstrates Favorable 12-Month Results Treating Peripheral Arterial Disease
October 18 2011 - 2:12PM
Business Wire
Data from Cardiovascular Systems’ (CSI) (Nasdaq: CSII) Predator
360° prospective single-center clinical study titled, Use of
Orbital Treatment in a High Volume Clinical Practice Modifies
Non-Compliant Plaque to Deliver Durable Long-Term Results,
presented today affirmed the procedural safety and efficacy, as
well as the long-term durability, of the Predator 360® PAD System
in treating peripheral arterial disease (PAD), or blockages in leg
arteries. The poster occurred today at the 2011 Vascular
Interventional Advances (VIVA) conference.
According to Principal Investigator Dr. Prakash Makam,
Cardiovascular Research of Northwest Indiana, Munster, Ind.,
“Twelve-month data shows the Predator 360° is a durable solution,
resulting in modified lesion compliance. This is reflected by short
treatment times, low-pressure balloon inflations post orbital
atherectomy treatment, and elimination of bailout stenting. The
Predator’s unique orbital mechanism of action with differential
sanding safely removes resistant plaque, reducing the need for
high-pressure balloon inflation and stenting.”
The study enrolled 46 patients at a single U.S. site.
Fifty-seven lesions, with an average blockage of 90 percent due to
plaque buildup, were treated using the Predator 360° PAD
System. Additionally, patients presented with symptoms that ranged
from severe pain to minor tissue loss due to their blocked
arteries. Patients underwent primary intervention with the Predator
360° orbital technology followed by adjunctive balloon inflations
if necessary, as determined by the physician.
Bailout stenting was not needed as a result of the efficacy of
orbital atherectomy technology. Use of the Predator 360° led to
durable results with a low (10.9 percent) reintervention rate
within 12 months. In contrast, balloon angioplasty typically
requires much higher balloon inflation pressures in fibrotic and
calcified plaques, and subsequent dissection rates range from 40
percent to 74 percent¹, with bailout stenting rates as high as 40
percent².
David L. Martin, CSI president and chief executive officer,
noted: “Dr. Makam’s study confirms previous data that demonstrates
our PAD therapy is safe and provides excellent long-term results.
Small, calcified vessels represent an understudied and challenging
treatment dilemma, and CSI is the only atherectomy company
providing physicians with the clinical and scientific data needed
to treat them. Prospective data accumulated to date confirm the
clinical and economic relevance of CSI’s orbital technology to
treat fibrotic and calcific vessels large and small, which was a
previously untreatable disease. CSI continues to lead the way in
collecting scientific PAD data through our ongoing active
360° Clinical Series program.”
Symposium Reviewed CSI Orbital TreatmentCSI technologies
and data from the 360° Clinical Series studies were
presented at a symposium, “Redefining the Algorithm for Outflow
Therapy” today in conjunction with the 2011 VIVA Conference.
Featured topics and speakers were:
- The Importance of Evidence-Based
Medicine
- Dr. George Adams, Rex/UNC Healthcare
(Raleigh, N.C.)
- Change Compliance FirstTM: Optimizing
Treatment Strategies for Femoropopliteal Disease
- Dr. Raymond Dattilo, St. Francis Health
Center (Topeka, Kan.)
- Best Practices for Plaque Modification
in Patients with Calcified Outflow – View full abstract
- Dr. Prakash Makam, Community Hospital
(Munster, Ind.)
- Restoring Runoff in Patients at Risk of
Amputation: Advanced Tips and Techniques
- Dr. J.A. Mustapha, Metro Health
Hospital (Wyoming, Mich.)
- The Next Frontier in Endovascular
Treatment
At VIVA, CSI is demonstrating its orbital PAD systems at Booth
No. 222.
About Peripheral Arterial DiseaseAs many as 12 million
Americans, most over age 65, suffer from PAD, which is caused by
the accumulation of plaque in peripheral arteries (commonly the
pelvis or leg) reducing blood flow. Symptoms include leg pain when
walking or at rest. Left untreated, PAD can lead to severe pain,
immobility, non-healing wounds and eventually limb amputation. With
risk factors such as diabetes and obesity on the rise, the
prevalence of PAD is growing at double-digit rates.
Millions of patients with PAD may benefit from treatment with
the Stealth 360°, Predator 360°, or Diamondback 360°
devices, minimally invasive catheter systems developed and
manufactured by CSI. These systems use a diamond-coated crown,
attached to a guide wire, which sands away plaque while preserving
healthy vessel tissue, or medial integrity — a critical factor in
preventing reoccurrences. Balloon angioplasty and stents have
significant shortcomings in treating hard, calcified lesions.
Stents are prone to fractures and high recurrence rates, and
treatment of hard, calcified lesions often leads to vessel damage
and suboptimal results.
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°TM,
Diamondback 360® and Predator 360® 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 55,000 PAD procedures have
been performed using CSI's PAD systems in leading institutions
across the United States.
CSI has also commenced its ORBIT II Investigational Device
Exemption clinical trial to evaluate the safety and effectiveness
of its orbital technology in treating coronary arteries. The
coronary system is limited by federal law to investigational use
and is currently not commercially available in the United
States.
For more information, visit the company’s website at
www.csi360.com.
Product DisclosureThe Stealth 360°TM, Diamondback 360®
and Predator 360® 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.
References:
- Fitzgerald P. Contribution of Localized
Calcium Deposits to Dissection After Angioplasty. Circulation 86
(1): 64-70.
- Laird J. Nitinol Stent Implantation
Versus Balloon Angioplasty for Lesions in the Superficial Femoral
Artery and Proximal Popliteal Artery. Circulation.3(3): 267.
Editor’s Note: For background information and images,
please go to www.csi360.com.
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