Impulse Dynamics Surpasses 10,000 Patients Benefiting From CCM® Therapy for Heart Failure
May 13 2024 - 9:30AM
Impulse Dynamics Surpasses 10,000 Patients Benefiting From CCM®
Therapy for Heart Failure
Impulse Dynamics, a global medical device company dedicated to
improving the lives of people with heart failure (HF), announced
today that it has reached a worldwide milestone by surpassing
10,000 patients having received the Optimizer® system for the
treatment of moderate HF. This milestone highlights the benefit and
importance of this therapy in helping patients live a full life
with HF.
"I noticed positive changes since the procedure, such as not
feeling cold or numb, I could walk every day and everywhere, did my
regular chores and shopping, and shared activities like swimming
with my daughter," said Tracey, who received her CCM® device in
2023. "I'm no longer huffing, puffing, or gasping for air," said
Joe, another HF patient who received his CCM device in 2022. "I'm
reborn ─ a whole new person ─ no longer incapacitated. My life has
changed so much that we're considering taking a trip. And my wife
is ecstatic because I have my life back, and we have ours
again."
"We are deeply motivated by the patients who benefit from CCM
therapy. Their progress inspires us to continuously enhance our
technology, aiming to improve the lives of those suffering from
heart failure," said David Prutchi, Chief Technology Officer for
Impulse Dynamics, who has worked on the development of CCM therapy
since its inception.
David had the opportunity to meet one of these patients,
Raynita, who was implanted with an Optimizer device this year.
Raynita saw immediate improvement after starting CCM therapy and
gave the following remarks on the experience: “I feel like a
different person. I can do things I haven’t done in years. I am
attending my granddaughter’s college graduation!”
CCM is available in 44 countries, and the technology has
continued to advance, based on the needs of patients and
physicians. The latest generation of the proprietary CCM technology
is the Optimizer Smart Mini, which offers a rechargeable battery
with 20-year battery life and a smaller size designed to make the
implant procedure faster and easier for patients and
physicians.
“We are committed to ongoing innovation in this important
therapy that has such a clear clinical need around the world,” said
Jason Spees, CEO of Impulse Dynamics. “We are also getting closer
to significantly impacting the implantable cardioverter
defibrillator (ICD) market with successful enrollment in our
INTEGRA-D clinical trial on the CCM-D® HF System, which is the
first-of-its-kind technology, combining the lifesaving benefits of
an ICD with HF symptom relief through CCM therapy in one
device.”
The patients statements in this Press Release represent the
testimonials of their individual outcomes and may not be typical
for all patients.
About the Optimizer and CCM Therapy The
Optimizer Smart Mini system delivers CCM therapy — the company’s
proprietary technology — to the heart, providing an important
treatment option for the millions of patients suffering from heart
failure. CCM therapy is designed to significantly improve heart
contraction, allowing more oxygen-rich blood to be pushed out
through the body.[1] CCM therapy is indicated to improve 6-minute
hall walk, quality of life, and functional status of NYHA Class III
HF patients who remain symptomatic despite guideline directed
medical therapy, are not indicated for CRT, and have a left
ventricular ejection fraction ranging from 25 to 45 percent.
CCM is the brand name for cardiac contractility modulation—the
non-excitatory electrical pulses delivered by the implantable
Optimizer device to improve heart contraction. CCM therapy sends
unique electrical pulses to the heart cells during the absolute
refractory period. In doing so, CCM helps the heart contract more
forcibly. Impulse Dynamics has completed numerous clinical studies,
including several randomized controlled trials, the results of
which appeared in more than 100 articles from leading medical
journals.
About Impulse Dynamics
Impulse Dynamics is dedicated to advancing the treatment of
heart failure for patients and the healthcare providers who care
for them. The company pioneered its proprietary CCM therapy, which
uses the Optimizer technology platform to improve quality of life
in HF patients. CCM therapy is delivered through the Optimizer
system, which includes an implantable pulse generator (IPG)
implanted in a minimally invasive procedure and approved for
commercial use in the United States and 44 countries worldwide.
More than 10,000 patients have received the therapy as part of
clinical trials and real-world use, where it is proven to be safe
and effective for heart failure patients with debilitating symptoms
who otherwise have few effective options available to them. To
learn more, visit www.ImpulseDynamics.com, or follow the company on
LinkedIn, X (formerly Twitter), and Facebook.
Forward-looking Statements
This press release contains forward-looking statements. All
statements other than statements of historical facts contained in
this press release are forward-looking statements. In some cases,
you can identify forward-looking statements by terms such as
‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’
‘‘anticipate,’’ ‘‘could,’’ ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’
‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’
‘‘potential’’ or ‘‘continue’’ or the negative of these terms or
other similar expressions, although not all forward-looking
statements contain these words. Forward-looking statements include,
but are not limited to, statements concerning potential benefits of
CCM therapy. These forward-looking statements are based on
management’s current expectations and involve known and unknown
risks and uncertainties that may cause our actual results,
performance or achievements to be materially different from any
future results, performance or achievements expressed or implied by
the forward-looking statements. Other important factors that could
cause actual results, performance or achievements to differ
materially from those contemplated in this press release include,
without limitation: the company’s future research and development
costs, capital requirements and the company’s needs for additional
financing; commercial success and market acceptance of CCM therapy;
the company’s ability to achieve and maintain adequate levels of
coverage or reimbursement for Optimizer systems or any future
products the company may seek to commercialize; competitive
companies and technologies in the industry; the company’s ability
to expand its indications and develop and commercialize additional
products and enhancements to its current products; the company’s
business model and strategic plans for its products, technologies
and business, including its implementation thereof; the company’s
ability to expand, manage and maintain its direct sales and
marketing organization; the company’s ability to commercialize or
obtain regulatory approvals for CCM therapy and its products, or
the effect of delays in commercializing or obtaining regulatory
approvals; FDA or other U.S. or foreign regulatory actions
affecting us or the healthcare industry generally, including
healthcare reform measures in the United States and international
markets; the timing or likelihood of regulatory filings and
approvals; and the company’s ability to establish and maintain
intellectual property protection for CCM therapy and products or
avoid claims of infringement. The company does not undertake any
obligation to update forward-looking statements and expressly
disclaims any obligation or undertaking to release publicly any
updates or revisions to any forward-looking statements contained
herein. These forward-looking statements should not be relied upon
as representing the company’s views as of any date subsequent to
the date of this press release.
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[1] European Journal of Heart Failure (2021)
doi:10.1002/ejhf.2202