Cardiovascular Systems, Inc. Acquires Gardia Medical Ltd.'s WIRION™ Embolic Protection System
August 05 2019 - 7:00PM
Business Wire
CSI to Commercialize Product upon Successful
Manufacturing Transfer
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 that it has acquired the
WIRION Embolic Protection System and related assets from Gardia
Medical Ltd., a wholly owned Israeli subsidiary of Allium Medical
Solutions Ltd. (TASE: ALMD).
The device, which received CE Mark in June 2015 and FDA
clearance in March 2018, is a distal embolic protection filter used
to capture debris that can be associated with all types of
peripheral vascular intervention (PVI) procedures. Physicians
typically use embolic protection devices in vessels located above
the knee with long lesions, high plaque burden and poor run
off.
Dr. Ehrin Armstrong, Professor of Medicine at the University of
Colorado, said, “The use of an embolic protection device during
peripheral interventions where the risk of embolization is higher
provides assurance and protection from procedural
complications.”
The WIRION System is easier to use and more versatile than other
available embolic protection systems because it can be used with
any .014” guidewire and for all types of peripheral interventions.
In addition, the WIRION System is the only embolic protection
device indicated for use with any atherectomy system. The WISE LE
study also demonstrated a major adverse event (MAE) rate of 1.9%,
which is lower than any other previously reported rates with other
embolic filters. Importantly, no clinically significant distal
embolization was observed when the WIRION System was used.
Asaf Alperovitz, Chief Executive Officer of Allium Medical
Solutions, said, “Allium Medical’s mission is to develop innovative
products to improve outcomes for patients around the world. We
believe the WIRION System from Gardia Medical, one of our portfolio
companies, will be highly synergistic with CSI’s growing portfolio
of products. We will continue to partner with CSI to execute a
timely manufacturing transfer and get the product in the hands of
physicians."
Scott Ward, CSI Chairman, President and Chief Executive Officer,
said, “The acquisition of the WIRION System further supports our
commitment and mission of building a comprehensive portfolio of
differentiated products aimed at saving limbs and improving
outcomes for patients undergoing complex peripheral
interventions.”
CSI plans to commercialize the WIRION System in the United
States following the transfer of manufacturing from Gardia Medical.
CSI expects the manufacturing transfer to be completed after a 12-
to 15-month transition period. Gardia will retain the rights to the
WIRION System for angioplasty and stenting procedures in the
carotid arteries.
About WISE LE WISE LE (WIRION™ EPS in Lower Extremities
Arteries) was a multicenter study, performed in the United States
and Germany and included all commercially-available atherectomy
systems. The primary endpoint was freedom from major adverse events
(MAEs) occurring within 30 days post-procedure and was compared
with an objective performance goal derived from historical
atherectomy trials. MAE was defined as a serious adverse event that
resulted in death, acute myocardial infarction, thrombosis,
pseudoaneurysm, dissection (grade C or greater), or clinical
perforation at the filter location, clinically relevant distal
embolism, unplanned amputation, or clinically driven target vessel
revascularization. The study also included a histopathological
analysis of debris captured by the filter during the
procedures.
About Gardia Medical Ltd. and Allium Medical Solutions
Ltd. Gardia Medical Ltd. develops specialized catheter-based
delivery systems to Deliver, Lock and Deploy devices on any
guidewire, anywhere on the wire, in minimally-invasive
interventional procedures. Allium Medical Solutions Ltd. develops,
manufactures and markets minimally invasive products
internationally in various medical disciplines. These innovative
products serve the need for minimally invasive interventions
benefitting the patient by improving their recovery process and
shortening it. Allium Medical Solutions’ products are used by
physicians to treat a wide range of diseases and patients
worldwide.
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
OAS 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.
The Stealth 360® Peripheral Orbital Atherectomy System (OAS)
received CE Mark in October 2014. Over 450,000 of CSI’s devices
have been sold to leading institutions worldwide.
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 CSI’s acquisition of the WIRION system; the benefits of
the WIRION system; the anticipated period of manufacturing
transfer; and the plans to commercialize the WIRION system, 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, unanticipated
developments during the manufacturing transfer process; regulatory
developments; the effectiveness of the WIRION system; the
experience of physicians regarding the effectiveness and
reliability of products sold by CSI; the reluctance of physicians,
hospitals and other organizations to accept new products; the
impact of competitive products and pricing; 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.
WIRION™ Embolic Protection System: The WIRION™ is
indicated for use as an embolic protection system to contain and
remove embolic material (thrombus/debris) while performing
angioplasty and stenting procedures in the carotid arteries and
atherectomy in calcified lesions of the lower extremities. The
diameter of the vessel at the site of the filter basket placement
should be between 3.5mm to 6.0mm. WIRION™ may be used with
commercially available 0.014” guidewires.
Contraindications
- Patients with severe allergy to Heparin
- Patients with uncorrected bleeding disorder
- Patients in whom anticoagulant and antiplatelet therapy is
contraindicated.
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version on businesswire.com: https://www.businesswire.com/news/home/20190805005653/en/
Cardiovascular Systems, Inc. Jack Nielsen (651) 202-4919
j.nielsen@csi360.com
Padilla: Matt Sullivan (612) 455-1709
matt.sullivan@padillaco.com
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