MARLBOROUGH, Mass.,
Sept. 21, 2020 /PRNewswire/ -- Boston
Scientific Corporation (NYSE: BSX) today announced it has signed an
investment agreement with an exclusive option to acquire Farapulse,
Inc., a privately-held company developing a pulsed field ablation
(PFA) system for the treatment of atrial fibrillation (AF) and
other cardiac arrhythmias. This PFA system – comprising a sheath,
generator and catheters – is intended to ablate heart tissue via
the creation of a therapeutic electric field instead of using
thermal energy sources such as radiofrequency ablation or
cryoablation.
Patients with AF, a common heart rhythm disorder that affects
more than 33 million people globally, are often treated with
anti-arrhythmic drugs as well as cardiac ablation.i
Ablation therapy is the process of delivering energy to areas of
the heart muscle responsible for creating an abnormal heart rhythm.
The Farapulse platform employs an ablation modality based on pulsed
electric fields, also referred to as irreversible electroporation,
that generates zones of ablated cardiac tissue to interrupt the
irregular electrical signals that can cause AF. This technology is
designed for physicians to precisely ablate tissue and, in turn,
spare nearby tissue from unintentional ablation.
"The tissue-selective Farapulse PFA technology is a promising
energy source for cardiac ablation – including pulmonary vein
isolation – with recent study results demonstrating the
effectiveness of the ultra-rapid approach," said Allan Zingeler, president and chief executive
officer, Farapulse, Inc. "This next chapter in our collaborative
relationship with Boston Scientific will further accelerate our
progress towards regulatory approval so we can bring this
pioneering system to market."
Farapulse is pursuing regulatory approval in the U.S. and
received FDA Breakthrough Designation for its endocardial ablation
system in May 2019 – a designation
intended to help patients receive more timely access to products
that may provide a substantial improvement over existing therapies.
The company intends to initiate a pivotal IDE trial in the U.S. and
is pursuing CE Mark approval in Europe.
"Our expanded investment in this technology, combined with our
recent CE Marked cryoablation and contact force catheters with
local impedance technology, affirms our commitment to offer
physicians an innovative and comprehensive portfolio of
electrophysiology products and services," said Scott Olson, senior vice president and
president, Rhythm Management, Boston Scientific.
*The Farapulse platform is an investigational
device and not available for sale.
About Boston Scientific
Boston Scientific transforms lives through innovative medical
solutions that improve the health of patients around the world. As
a global medical technology leader for 40 years, we advance science
for life by providing a broad range of high performance solutions
that address unmet patient needs and reduce the cost of healthcare
For more information,
visit www.bostonscientific.com and connect
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Cautionary Statement Regarding Forward-Looking
Statements
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. Forward-looking
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performance. These forward-looking statements include, among other
things, statements regarding the financial and business impact of
the transaction, product launches and product performance and
impact. If our underlying assumptions turn out to be incorrect, or
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vary materially from the expectations and projections expressed or
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CONTACTS:
Trish Backes
Media Relations
(651) 582-5887
Trish.Backes@bsci.com
Susie Lisa, CFA
Investor Relations
(508) 683-5565
BSXInvestorRelations@bsci.com
i Chugh SS, et al. Worldwide epidemiology of
atrial fibrillation: a global burden of disease 2010 study.
Circulation 2014;129:837–847. doi:
https://doi.org/10.1161/CIRCULATIONAHA.113.005119.
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SOURCE Boston Scientific Corporation