Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the
development and commercialization of transformational technologies
for the treatment of cardiovascular disease, announced today the
planned U.S. introduction of the Shockwave C2+ Coronary
Intravascular Lithotripsy (IVL) catheter following approval by the
U.S. Food and Drug Administration. The Shockwave C2+ catheter
provides 50 percent more pulses per catheter than the Shockwave C2
catheter that was approved in the U.S. in 2021. The enhanced C2+
catheter will make its U.S. debut at the 35th Transcatheter
Cardiovascular Therapeutics (TCT) annual scientific symposium of
the Cardiovascular Research Foundation, with the full commercial
launch planned for the beginning of November.
“The enhancements of Shockwave C2+ will be an added benefit of
IVL for optimally treating complex calcium, including more diffuse
disease, as well as nodular and thick, eccentric calcium,” said
Richard Shlofmitz, MD, Chairman, Department of Cardiology, St.
Francis Hospital in Roslyn, New York, who performed the first U.S.
commercial case with Shockwave C2+. “When additional pulses are
added to the existing intuitive catheter design and simple-to-use
system that are foundational to the success of Shockwave IVL, the
result is an updated catheter that can enhance workflow and improve
procedural efficiency.”
TCT23 to Feature New Coronary IVL Data and Insights and
Symposia on COSIRA-II
The following scientific sessions and symposia supporting
Shockwave Medical’s growing portfolio of technologies and clinical
studies will be taking place at TCT:
Monday, October 23, 2023
TCT WorldLink Latin
America Featured Clinical Science: Complex Coronary
Intervention |
Presentation Title: |
|
Shock India Registry: Multicenter Registry of Coronary IVL in
Calcified Coronary Arteries in Real-World Indian Patient
Population |
Time and Location: |
|
10:30 AM – 10:41 AM; Presentation
Theater 3, Room 215, Level 2, Moscone South |
Presenter: |
|
Prof. Ashok Seth, MBBS*, Fortis
Escorts Heart Institute & Research Centre |
Tuesday, October 24, 2023
Shockwave Medical
Sponsored Symposia |
Presentation Title: |
|
The COSIRA-II Trial: Designed To Demonstrate Refractory Angina
Relief with the Coronary Sinus Reducer |
Time and Location: |
|
2:00 PM – 3:00 PM, Presentation
Theater 1, Room 205, Level 2, Moscone South |
Presenters: |
|
Gregg W. Stone, MD, Mount Sinai
Heart Health System; Allen Jeremias, MD*, St. Francis Hospital;
Timothy D. Henry, MD, The Christ Hospital; Prof. Stefan Verheye*,
ZNA Middelheim Hospital; Megha Prasad, MD, New York-Presbyterian
Columbia University Irving Medical Center |
Wednesday, October 25, 2023
Shockwave Medical
Sponsored Symposia |
Presentation Title: |
|
TOPSHOCK: Vote for this Year’s Best Coronary IVL Case |
Time and Location: |
|
11:00 AM – 12:00 PM, Presentation
Theater 1, Room 205, Level 2, Moscone South |
Presenters: |
|
Prof. James C. Spratt, MD*, St.
George's University Hospitals NHS Trust; Ziad Ali, MD*, St. Francis
Hospital; Kalaivani Mahadevan, MD*, Portsmouth Hospitals University
NHS Trust; Tim O’Connor, MD*, Beaumont Hospital; Sameh Sayfo, MD*,
Baylor Scott & White, The Heart Hospital |
Thursday, October 26, 2023
Coronary Spotlight
Session: Calcium – How Hard Should We Try? |
Presentation Title: |
|
Coronary IVL in the US: Trends, Hospital Variation, &
Predictors of Use: Insights From the ACC NCDR CathPCI Registry |
Time and Location: |
|
10:42 AM – 10:50 AM, Coronary
Spotlight Theater, Hall E, Exhibition Level, Moscone North |
Presenter: |
|
Neel Butala, MD*, UCHealth
University of Colorado Hospital |
Shockwave Medical
Sponsored Symposia |
Presentation Title: |
|
Coronary IVL: More Pulses, More Data, More Insights |
Time and Location: |
|
12:45 PM – 1:45 PM, Presentation
Theater 2, Room 208, Level 2, Moscone South |
Presenters: |
|
Yousif Ahmad, M.D.*, Yale
Medicine; Neel Butala, MD*, UCHealth University of Colorado
Hospital; Prof. Ashok Seth, MBBS*, Fortis Escorts Heart Institute
& Research Centre; Prof. Gennaro Sardella, MD*, Presso
Policlinico Umberto; Ziad Ali, MD*, St. Francis Hospital; Darshan
Doshi, MD*, Massachusetts General Hospital |
A detailed agenda for all Shockwave Medical symposia and
featured presentations can be found here.
Shockwave C2+ is commercially available for the treatment of de
novo coronary artery disease in the United States, Europe and
select other geographies.
About Shockwave Medical, Inc.
Shockwave Medical is a leader in the development and
commercialization of innovative products that are transforming the
treatment of cardiovascular disease. Its first-of-its-kind
Intravascular Lithotripsy (IVL) technology has transformed the
treatment of atherosclerotic cardiovascular disease by safely using
sonic pressure waves to disrupt challenging calcified plaque,
resulting in significantly improved patient outcomes. Shockwave has
also recently acquired the Neovasc Reducer, which is under clinical
investigation in the United States and Canada, and is CE Marked in
the Europe. By redistributing blood flow within the heart, the
Reducer is designed to provide relief to the millions of patients
worldwide suffering from refractory angina. Learn more
at www.shockwavemedical.com and www.neovasc.com.
About ReducerWhile under clinical investigation
in the COSIRA-II trial (U.S. and Canada), the Reducer is CE-marked
for the treatment of refractory angina, a painful and debilitating
condition that occurs when the coronary arteries deliver an
inadequate supply of blood to the heart muscle, despite treatment
with standard revascularization or cardiac drug therapies. It
affects millions of patients worldwide, who typically lead severely
restricted lives as a result of their disabling symptoms, and its
incidence is growing. The Reducer provides relief of angina
symptoms by altering blood flow within the myocardium of the heart
and increasing the perfusion of oxygenated blood to ischemic areas
of the heart muscle. Placement of the Reducer is performed using a
minimally invasive transvenous procedure.
Forward-Looking Statements
This press release contains statements relating to our
expectations, projections, beliefs, and prospects, which are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. In some cases, you can
identify these statements by forward-looking words such as “may,”
“might,” “will,” “should,” “expects,” “plans,” “anticipates,”
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similar expressions, and the negative of these terms.
Forward-looking statements in this press release include, but are
not limited to, statements regarding our ability to design,
develop, manufacture and market innovative products to treat
patients with challenging medical conditions, particularly in
coronary artery disease; our ability to successfully execute our
commercialization strategy for our approved or cleared products;
our business strategy and plans, our objectives for future
operations, and other matters. You are cautioned not to place undue
reliance on these forward-looking statements. Forward-looking
statements are only predictions based on our current expectations,
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Important factors that could cause our actual results and
financial condition to differ materially from those indicated in
the forward-looking statements include, among others: the impact of
macroeconomic conditions, including inflation, rising interest
rates, the federal budget, instability in the global banking
system, and volatile market conditions, geopolitical factors,
including the ongoing conflict between Russia and Ukraine and
responses thereto, and supply chain disruptions, on our operations,
financial results, liquidity, capital resources, expenses, supply
chain, manufacturing, research and development activities, clinical
trials, and employees; our ability to successfully execute our
business and growth strategies; our ability to develop,
manufacture, obtain and maintain regulatory approvals for, and
market and sell, our products; our expected future growth,
including the size and growth potential of the markets for our
products; our ability to obtain coverage and reimbursement for
procedures performed using our products; our ability to scale our
organizational culture; the impact of the development, regulatory
approval, efficacy and commercialization of competing products; the
loss of key scientific or management personnel; our ability to
develop and maintain our corporate infrastructure, including our
internal controls; our financial performance and capital
requirements; the success of any acquisitions that we make; and our
ability to obtain and maintain intellectual property protection for
our products, as well as our ability to operate our business
without infringing the intellectual property rights of others.
These factors, as well as others, are discussed in our filings with
the Securities and Exchange Commission (SEC), including in the
sections titled “Risk Factors” in our most recent Annual Report on
Form 10-K and subsequently filed Quarterly Reports on Form 10-Q,
and in our other reports filed with the SEC. Except to the extent
required by law, we do not undertake to update any of these
forward-looking statements after the date hereof to conform these
statements to actual results or revised expectations.
Media Contact:Scott
Shadiow+1.317.432.9210sshadiow@shockwavemedical.com
Investor Contact:Debbie Kasterdkaster@shockwavemedical.com
*Physicians are paid consultants of Shockwave Medical.
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