Cardiovascular Systems, Inc. (CSI) (NASDAQ:CSII), will release
two-year data from its ORBIT II study of the company’s Diamondback
360® Coronary Orbital Atherectomy System (OAS) in treating severely
calcified lesions at the 2015 Cardiovascular Research Technologies
(CRT) conference in Washington, D.C., Feb. 21-24, 2015.
The pivotal ORBIT II study evaluated the safety and
effectiveness of the company’s orbital atherectomy technology, and
CSI completed ORBIT II enrollment of 443 patients at 49 U.S.
medical centers in November 2012. In October 2013, the company
received PMA approval from the U.S. Food and Drug Administration
(FDA) to market its Diamondback 360 Coronary Orbital Atherectomy
System as a treatment for severely calcified coronary arteries.
It is estimated that significant arterial calcium is present in
nearly 40 percent of patients treated with interventional
therapies. Calcium can cause complications, including difficult
stent deployment, dissections and, when stents are under expanded,
it can result in the need for a coronary bypass. Since receiving
approval, CSI has continued the controlled commercial launch of its
Diamondback Coronary Orbital Atherectomy System (OAS) in the United
States and more than 4000 patients have been treated using CSI’s
unique technology.
Late Breaking Presentation: ORBIT II
Two-Year DataTITLE: Jeffrey Chambers, MD,
Metropolitan Heart and Vascular Institute, Minneapolis, Minn., will
present “Diamondback 360o Coronary Orbital Atherectomy System for
Treating De Novo, Severely Calcified Lesions: 2-Year Results of the
Pivotal ORBIT II Trial.”
WHEN: Monday, Feb. 23, 2 p.m.
WHERE: Omni Shoreham HotelBallroom2500 Calvert Street
NWWashington, DC 20008
Podium Presentation: Advanced
Trans-Radial Intervention Masters CourseTITLE:
Mitchell W. Krucoff, MD, The Duke Heart Center, Durham, N.C., will
present “Calcific Lesions with Left Ventricular Assist: Radial
Orbital Atherectomy” as a Masters Course.
WHEN: Monday, Feb. 23, 7:05 a.m.
WHERE: Omni Shoreham HotelBlue Room2500 Calvert Street
NWWashington, DC 20008
Poster
PresentationsTITLE: Jeffrey Chambers, MD,
Metropolitan Heart and Vascular Institute, Minneapolis, Minn., and
Arthur Lee, M.D., Interventional Cardiologist, The Cardiac &
Vascular Institute, Gainesville, Fla., will present “One-Year
Safety Outcomes in Diabetic Patients Treated with Orbital
Atherectomy for De Novo, Severely Calcified Coronary Lesions: A
Sub-Analysis of the ORBIT II Clinical Trial.”
TITLE: Louis P. Garrison, PhD, University of Washington
School of Pharmacy, Seattle, Wash., will present “The Clinical and
Cost Burden of Coronary Calcification in a Medicare Cohort: An
Economic Model to Address Under-Reporting and
Misclassification.”
TITLE: Jeffrey Chambers, MD, Metropolitan Heart and
Vascular Institute, Minneapolis, Minn., and Arthur Lee, M.D.,
Interventional Cardiologist, The Cardiac & Vascular Institute,
Gainesville, Fla., will present “Orbital Atherectomy Treatment of
Severely Calcified Coronary Lesions in Patients with History of
Coronary Artery Bypass Grafting: One-Year Safety Outcomes from
ORBIT II Trial.”
WHEN: Monday, Feb. 23, 8 a.m.
WHERE: Omni Shoreham HotelExhibit Hall2500 Calvert Street
NWWashington, DC 20008
Live
DemonstrationTITLE: Samin Sharma, MD, The Mount
Sinai Hospital Cardiac Cath Lab, New York City, will present a live
orbital atherectomy coronary case demonstration.
WHEN: Monday, Feb. 23, 2:20 p.m.
WHERE: Omni Shoreham HotelRegency Ballroom2500 Calvert
Street NWWashington, DC 20008
CRT CME Dinner Symposium
PresentationsTITLE: Renu Virmani, MD, CVPath
Institute, Inc. Gaithersburg, Md., will present “Calcium
in the Peripheral Arteries: The Pathologist View.”TITLE:
Elazer Edelman, MD, CBSET, Inc., Lexington, Mass. and MIT,
Cambridge, Mass., will present “Effects of Orbital Atherectomy
Treatment on Drug Absorption in Calcified Peripheral
Arteries.”TITLE: Philppe Généreux, MD, Cardiovascular
Research Foundation, New York, N.Y., will present “Impact of
Coronary Calcified Lesions on Outcome Across Devices.”TITLE:
Jeffrey Chambers, MD, Metropolitan Heart and Vascular Institute,
Minneapolis, Minn., will present “ORBIT II Clinical and Economic
Data Update.”TITLE: David Cohen, MD, Saint Luke's Mid
America Heart Institute, Kansas City, Mo., will present “MACE
Clinical Study Design and Preliminary Data.”TITLE: Gus
Pichard, MD, MedStar Washington Hospital Center, MedStar Heart
Institute, Washington, DC, and Azeem Latib, MD, San Raffaele
Scientific Institute, Milan, Italy, will present “Vessel
Preparation of Calcified Lesions Case Reviews.”
WHEN: Sunday, Feb. 22, 7:30 p.m.
WHERE: Omni Shoreham HotelDiplomat Room2500 Calvert
Street NWWashington, DC 20008
CSI Booth at CRTVisit CSI at
booth #104 11 a.m. – 7:30 p.m. Sunday, Feb. 22; 8 a.m. – 5 p.m.
Monday, Feb. 23; and 9 a.m. – 2 p.m. Tuesday, Feb. 24, to meet the
company’s calcium experts and learn more about its unique orbital
technology.
About Peripheral Artery Disease (PAD)As many as 18
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
orbital atherectomy utilizing the Stealth 360 and Diamondback 360
Peripheral Orbital Atherectomy Systems, minimally invasive catheter
systems developed and manufactured by CSI. These systems use a
diamond-coated crown, attached to an orbiting shaft, which sands
away plaque while preserving healthy vessel tissue — 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 Coronary Artery DiseaseCAD is a life-threatening
condition and a leading cause of death in men and women in the
United States. CAD occurs when a fatty material called plaque
builds up on the walls of arteries that supply blood to the heart.
The plaque buildup causes the arteries to harden and narrow
(atherosclerosis), reducing blood flow. The risk of CAD increases
if a person has one or more of the following: high blood pressure,
abnormal cholesterol levels, diabetes, or family history of early
heart disease. According to the American Heart Association, 16.3
million people in the United States have been diagnosed with CAD,
the most common form of heart disease. Heart disease claims more
than 600,000 lives in the United States each year. According to
estimates, significant arterial calcium is present in nearly 40
percent of patients undergoing a percutaneous coronary intervention
(PCI). Significant calcium contributes to poor outcomes and higher
treatment costs in coronary interventions when traditional
therapies are used, including a significantly higher occurrence of
death and major adverse cardiac events (MACE).
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 Orbital Atherectomy
Systems treat calcified and fibrotic plaque in arterial vessels
throughout the leg and heart 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
Orbital Atherectomy System in peripheral arteries in August 2007.
In October 2013, the company received FDA approval for the use of
the Diamondback Orbital Atherectomy System in coronary arteries. To
date, nearly 182,000 of CSI’s devices have been sold to leading
institutions across the United States. For more information, visit
the company’s website at www.csi360.com.
Product Disclosures:
Peripheral Products
The Stealth 360® PAD System and Diamondback
360® PAD System 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.
Coronary ProductIndications: The Diamondback 360®
Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital
atherectomy system indicated to facilitate stent delivery in
patients with coronary artery disease (CAD) who are acceptable
candidates for PTCA or stenting due to de novo, severely calcified
coronary artery lesions.
Contraindications: The OAS is contraindicated when the
ViperWire guide wire cannot pass across the coronary lesion or the
target lesion is within a bypass graft or stent. The OAS is
contraindicated when the patient is not an appropriate candidate
for bypass surgery, angioplasty, or atherectomy therapy, or has
angiographic evidence of thrombus, or has only one open vessel, or
has angiographic evidence of significant dissection at the
treatment site and for women who are pregnant or children.
Warnings/Precautions: Performing treatment in excessively
tortuous vessels or bifurcations may result in vessel damage; The
OAS was only evaluated in severely calcified lesions, A temporary
pacing lead may be necessary when treating lesions in the right
coronary and circumflex arteries; On-site surgical back-up should
be included as a clinical consideration; Use in patients with an
ejection fraction (EF) of less than 25% has not been evaluated. See
the instructions for use before performing Diamondback 360 Coronary
OAS procedures for detailed information regarding the procedure,
indications, contraindications, warnings, precautions, and
potential adverse events. For further information call CSI at
1-877-274-0901 and/or consult CSI’s website at www.csi360.com.
Caution: Federal law (USA) restricts this device to sale
by or on the order of a physician.
Cardiovascular Systems, Inc.Jack Nielsen,
651-202-4919j.nielsen@csi360.comorPadillaCRTMatt Sullivan,
612-455-1709matt.sullivan@padillacrt.com
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