KAIZEN to assess safety and efficacy of
peripheral orbital atherectomy to secure regulatory approval in
Japan
Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical
device company developing and commercializing innovative
interventional treatment systems for patients with peripheral and
coronary artery disease, announced today the company has initiated
the KAIZEN clinical study of its Diamondback 360© Peripheral
Orbital Atherectomy System (OAS) for the treatment of calcified
plaque in patients with peripheral artery disease (PAD). The study
is intended to support regulatory approval in Japan.
The first KAIZEN patient was enrolled by Tatsuya Nakama, M.D.,
Vice Director, Department of Cardiology, Tokyo Bay Urayasu Ichikawa
Medical Center.
Dr. Nakama said, “I felt that the Diamondback 360© Peripheral
OAS offered both effective treatment and ease of use. I was able to
observe significant vessel compliance change, which permitted
satisfactory balloon expansion at low pressure. Additionally, I
felt that minimal distal embolism compared to other devices
throughout the procedure was greatly comforting. I look forward to
further evaluation of the device, but believe it will be seen as a
highly welcomed tool in the battle against calcified vessels.”
The Diamondback 360© Peripheral OAS is a minimally invasive,
single-use, catheter-based device that is uniquely designed to
differentiate between hard, diseased plaque and healthy, compliant
arterial tissue. The OAS orbiting crown reduces and modifies
calcified plaque while preserving the healthy vessel wall in order
to restore blood flow.2,3,4
KAIZEN is a prospective, single-arm, multi-center study led by
Hiroyoshi Yokoi, M.D., Interventional Cardiologist, Director of the
Cardiovascular Medicine Center and Director, Fukuoka Sanno
Hospital. The study is designed to evaluate the safety and efficacy
of CSI’s Diamondback 360© Peripheral OAS in the treatment of de
novo symptomatic calcified occlusive atherosclerotic lesions in the
superficial femoral artery and/or popliteal artery. OAS has
demonstrated safety and efficacy in the U.S. population and this
study is designed to confirm this in Japan. The study is expected
to enroll up to 100 subjects at up to 12 study sites.
Dr. Yokoi said, “Severely calcified peripheral vessels continue
to be a significant challenge for both patient and caregiver, and
the need for new treatment devices is greater than ever. I believe
the Diamondback 360© Peripheral OAS has great potential for this
underserved patient population, and I look forward to evaluating it
in Japan. In addition, the high use of imaging by practitioners in
Japan will provide greater insight into lesion morphology, and I am
confident that this will also help us optimize treatment and safety
using OAS.”
PAD is due to accumulation of plaque in the peripheral arteries
(atherosclerosis). PAD complexity increases as atherosclerotic
plaques become more calcified.1 Numerous endovascular treatments
are available, such as balloons and stents to restore blood flow in
blocked arteries. However, calcified lesions are more difficult to
treat during these procedures, leading to decreased balloon and
stent success and higher procedural complication rates.1
Scott R. Ward, CSI’s Chairman, President and Chief Executive
Officer, said, “We look forward to completing KAIZEN and working
with the investigators and regulators so that we may offer
peripheral OAS therapy to physicians in Japan.”
About Peripheral Artery Disease (PAD)
An estimated eight to 10 million Japanese suffer from PAD, which
is caused by the accumulation of plaque in peripheral arteries
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.
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 system treats calcified and
fibrotic plaque in arterial vessels throughout the leg and heart
and addresses many of the limitations associated with existing
surgical, catheter and pharmacological treatment alternatives. For
more information, visit www.csi360.com and follow us on LinkedIn
and Twitter.
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 provided under the protection of the
safe harbor for forward-looking statements provided by that Act.
For example, statements in this press release regarding the KAIZEN
study, regulatory approval of peripheral OAS in Japan, and the
commercial introduction of peripheral OAS in Japan, are
forward-looking statements. These statements involve risks and
uncertainties that 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
the KAIZEN study; the effectiveness of peripheral OAS in the study;
actual clinical results; regulatory developments, clearances and
approvals; approval of our products for distribution in Japan;
approval of products for reimbursement and the level of
reimbursement in Japan; general economic conditions; and other
factors detailed from time to time in CSI’s SEC reports, including
its most recent annual report on Form 10-K and subsequent quarterly
reports on Form 10-Q. 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.
CSI® and Diamondback 360® are trademarks of Cardiovascular
Systems, Inc.
Product Disclosure:
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. See the
instructions for use 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.
This system is not commercially available Japan.
- Rocha Singh,K.J.,Zeller,T.& Jaff, M.R. Peripheral arterial
calcification: prevalence, mechanism, detection, and clinical
implications. Catheter Cardiovasc Interv 83,
E212-220,doi:10.1002/ccd.25387(2014).
- Safian, R. D. et al. Orbital atherectomy for infrapopliteal
disease: device concept and outcome data for the OASIS trial.
Catheter
CardiovascInterv73,406-412,doi:10.1002/ccd.21898(2009).
- Babaev, A. et al. Orbital Atherectomy Plaque Modification
Assessment of the Femoropopliteal Artery Via Intravascular
Ultrasound (TRUTH Study).Vasc Endovascular Surg 49,
188-194,doi:10.1177/1538574415607361(2015).
- Adams, G. L., Khanna, P. K., Staniloae, C. S.,Abraham, J. P.
& Sparrow, E. M. Optimal techniques with the Diamondback 360
degrees System achieve effective results for the treatment of
peripheral arterial disease. J Cardiovasc Transl Res 4,
220-229,doi:10.1007/s12265-010-9255-x(2011).
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version on businesswire.com: https://www.businesswire.com/news/home/20230111005773/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com
Cardiovascular Systems (NASDAQ:CSII)
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