Cardiovascular Systems, Inc. Announces First In-Human Experience With Company’s Propel™ Percutaneous Ventricular Assist Device
March 16 2022 - 9:32AM
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 first in-human
experience with Propel™, its first-generation percutaneous
ventricular assist device (pVAD), offering hemodynamic support for
patients undergoing high-risk percutaneous coronary interventions
(HR-PCI).
The first series of patients was treated by Dr. David E.
Kandzari, MD, FACC, FSCAI, Chief, Piedmont Heart Institute and
Cardiovascular Services, Atlanta, Ga., performed in Tbilisi,
Georgia. Propel performed as intended, providing uninterrupted
hemodynamic support leading to successful revascularization.
Propel is designed to meet the needs of the HR-PCI patient by
providing clinically meaningful hemodynamic support while
minimizing access site and procedural complications due to a small
profile pump and smaller catheter body versus the current pVAD
systems that are commercially available. Propel is percutaneously
inserted, and the blood inlet portion of the device is positioned
within the left ventricle below the aortic valve, and the outlet
positioned above the aortic valve.
Propel was used at multiple support levels, with a hemodynamic
power output and duration sufficient to maintain the stability of
patients during their HR-PCI.
As one of the study investigators, Dr. Kandzari said, “This is a
novel pVAD system that enables a 12 French in-body pump with a 7
French in-body catheter. This reduction in size may reduce the
clinical complications associated with high-risk procedures while
providing the clinically necessary cardiac support for the patient.
The lower catheter profile may also increase the potential for use
in patients with challenging anatomy that exclude treatment with
current therapies.”
“Today’s announcement is another important milestone for CSI as
we seek to develop an exciting pipeline of new products designed to
improve the outcomes for patients with coronary artery disease,”
said Scott R. Ward, Chairman, President and Chief Executive Officer
of CSI. “We appreciate Dr. Kandzari’s commitment and willingness to
participate in these first cases. Conducting the first in-human
cases outside the U.S. increases the confidence we have in Propel
and furthers the development of this program. We continue to work
closely with FDA, and the data from these cases will inform the
design and conduct of an early feasibility study in the U.S.”
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 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, arterial calcium is present in 38 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).
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.
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 Propel; (ii) future clinical studies and regulatory
submissions relating to Propel; and (iii) CSI’s product pipeline,
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
to develop Propel; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220314005869/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com
Cardiovascular Systems (NASDAQ:CSII)
Historical Stock Chart
From Jun 2024 to Jul 2024
Cardiovascular Systems (NASDAQ:CSII)
Historical Stock Chart
From Jul 2023 to Jul 2024