Cardiovascular Systems, Inc. Announces First In-Human Experience With Coronary Everolimus Drug Coated Balloon
05 November 2021 - 4:00AM
Business Wire
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 start of enrollment in
a first in-human trial of the coronary everolimus drug-coated
balloon (DCB) being developed by Chansu Vascular Technologies, LLC
(CVT).
The first patient was successfully treated by Dr. Irakli
Gogorishvili, Head of the Interventional Cardiology Department, at
the Israeli-Georgian Medical Research Clinic Helsicore in Tbilisi,
Georgia. The coronary DCB was used to treat in-stent restenosis
(ISR) located in the left anterior descending artery.
DCBs are a widely accepted percutaneous interventional treatment
option for femoro-popliteal lesions in patients with peripheral
artery disease, and are increasingly recognized for their potential
in complex coronary artery disease, ISR, small vessels, and
bifurcation lesions.
Everolimus, the active drug in CVT’s DCB formulation, acts as a
cytostatic agent to reduce tissue hyperplasia and associated
restenosis and has a long history of safety and efficacy in
coronary drug-eluting stent applications.
Dr. Gogorishvili said, “The crossability and deliverability of
the CVT DCB is excellent and I am very excited to participate in
this research project evaluating this new class of DCBs.”
Ryan Egeland, MD, PhD, CSI’s Chief Medical Officer, said, “The
CVT DCBs are designed to capitalize on the proven long-standing
anti-restenotic benefits of everolimus for the treatment of
patients with cardiovascular lesions. CVT intends to enroll 50
patients at up to 15 sites in France, Georgia, Lithuania and Spain
to support an IDE submission to the FDA and a subsequent U.S.
pivotal clinical study.”
Under the terms of the agreements signed with CVT, CSI is
providing milestone-based financing to CVT for the development of
coronary and peripheral DCBs. Under an acquisition option
agreement, upon CVT’s completion of key technical and clinical
milestones in the development program, CSI will have exclusive
rights and obligations to acquire CVT, subject to the satisfaction
of closing conditions set forth in the agreement.
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
additional information, please visit www.csi360.com and connect on
Twitter @csi360.
About Chansu Vascular Technologies, LLC
Chansu Vascular Technologies (CVT) is a company with its
principal office located in Sunnyvale, California. CVT was founded
by Philippe Marco, MD, with the exclusive purpose to develop
peripheral and coronary DCBs using everolimus. Dr. Marco is a
25-year medical technology veteran who has spent his entire career
focused on cardiovascular device development. He was President and
COO of Epix Therapeutics (acquired by Medtronic), and President and
COO at CV Ingenuity (acquired by Covidien), where he was
responsible for the development of the Stellarex™ DCB. Dr. Marco
started working on drug delivery cardiovascular devices while in
charge of Medical Affairs for Abbott Vascular where, following the
Perclose Inc. acquisition, he led the franchise expansion into a
diversified portfolio from closure devices to drug-coated coronary
stents, embolic protection devices, and peripheral catheters and
stents.
About Coronary Artery Disease (CAD)
CAD is a life-threatening condition and a leading cause of death
in men and women globally. 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 Centers for Disease Control and
Prevention, 18.2 million people in the United States have CAD, the
most common form of heart disease. Heart disease claims more than
650,000 lives in the United States each year. According to
estimates, significant arterial calcium is present in about 30
percent of patients undergoing a PCI. Significant calcium
contributes to poor stent delivery, expansion and wall apposition
leading 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).
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 (i) the
development of new DCBs; (ii) the benefits of DCBs and everolimus;
(iii) clinical studies relating to the DCBs; (iv) the ability of
CVT, Dr. Marco and his team to successfully develop the DCBs; (v)
future milestone-based financing in CVT; (vi) the future impact of
adding DCBs to CSI’s portfolio; and (vii) the potential acquisition
of CVT by CSI, 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
ability of CSI and CVT to collaborate on the development of new
DCBs; the ability of CVT to meet development milestones;
satisfaction of the conditions to CSI’s additional financing
obligations; satisfaction of milestones and conditions to CSI’s
rights and obligations to acquire CVT; technical challenges;
regulatory developments; clinical trial requirements and results;
FDA clearances and approvals; 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; 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 is a registered trademark of Cardiovascular Systems, Inc.
All other trademarks cited herein are owned by their respective
owners.
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version on businesswire.com: https://www.businesswire.com/news/home/20211104005813/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com
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