Additional real-world outcomes further
demonstrate safety, efficacy and procedural reproducibility of the
FARAPULSE™ Pulsed Field Ablation System*
Results from global trial of the POLARx™
Cryoablation System* meet safety and effectiveness
endpoints
MARLBOROUGH, Mass., May 20, 2023
/PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today
announced data supporting use of the company's key
electrophysiology and cardiac rhythm management therapies, and the
WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. All data
were presented at Heart Rhythm 2023, the annual meeting of the
Heart Rhythm Society, held in New
Orleans from May 19-21.
Real-world outcomes from the EU-PORIA registry of the
FARAPULSE™ Pulsed Field Ablation (PFA) System
Real-world outcomes from the multi-center EU-PORIA registry were
highlighted in a late-breaking data presentation, further
demonstrating the safety, efficacy and learning curve
characteristics of the FARAPULSE PFA System. The registry data
included favorable single procedure success rates, along with
efficient procedure times in a broad patient population. More than
1,200 patients with paroxysmal or persistent atrial fibrillation
(AF)** were enrolled and treated at seven high-volume European
centers.
Key findings from the registry:
- Rates of freedom from recurrence of AF and atrial tachycardia
were high at 74.0% per the Kaplan-Meier estimate at a median
follow-up of one year. The freedom from recurrence rate was 80.0%
in patients with paroxysmal AF and 66.0% in patients with
persistent AF.
- Level of physician experience with AF ablation did not impact
procedure times or patient outcomes, reinforcing the procedural
reproducibility of the FARAPULSE PFA System.
- Data demonstrated a predictable workflow with a median of 58
minutes within an interquartile range of 40 to 87 minutes.
- There was a 1.7% major complication rate and 1.9% minor
complication rate with no reported esophageal damage or pulmonary
vein stenosis and a single case of sustained phrenic nerve palsy,
which was reported in the MANIFEST PF study.
Primary results of the FROZEN-AF IDE trial with the POLARx™
Cryoablation System
Results from the global, prospective, non-randomized, single-arm
FROZEN-AF IDE study of the POLARx Cryoablation System met the
safety and effectiveness endpoints of the trial. The study, which
examined use of the device for the treatment of patients with
paroxysmal, or intermittent atrial fibrillation (AF), included an
extension arm for the POLARx FIT Cryoballoon Catheter, a single
device capable of enabling 28 and 31mm sizes. The extension arm
sub-study also achieved its safety and effectiveness endpoints and
included 50 patients who were treated with at least one application
of the 31mm cryoballoon and will be followed for 12 months. At the
time of data release, patients had undergone six out of a total of
12 months of follow up.
Key findings from the trial:
- The primary safety endpoint of composite acute and chronic
primary safety events through 12 months was achieved with an
event-free rate of 96.3% at 12 months in the IDE trial and 100% at
six months in the extension arm of the study.
- There were no reports of moderate or severe pulmonary vein
stenosis, persistent phrenic nerve palsy or esophageal fistulas in
either patient cohort.
- The rate of freedom from documented atrial arrhythmias was
79.9% at 12 months in the IDE trial and 88.0% at six months in the
extension arm.
Effects of the EMBLEM MRI™ Subcutaneous Implantable
Defibrillator (S-ICD) on tricuspid regurgitation
Data from a secondary analysis of the investigator-sponsored,
randomized ATLAS trial compared among nearly 450 patients the
severity of tricuspid regurgitation at six months following the
implantation of a transvenous implantable
cardioverter-defibrillator (TV-ICD) versus the EMBLEM MRI S-ICD.
Tricuspid regurgitation is a disease that occurs when the tricuspid
valve does not close properly and is a risk factor for heart
failure.
Key findings from the analysis:
- At six months, patients in the TV-ICD group were seven times
more likely to have worsening tricuspid regurgitation.
- Of those with worsening tricuspid regurgitation, moderate or
severe symptoms developed in 6.9% of patients receiving a TV-ICD
versus 2.3% of those receiving an S-ICD.
Hybrid strategy for secondary prevention of sudden cardiac
death using ventricular tachycardia (VT) ablation and the EMBLEM
MRI S-ICD
The prospective, investigator-sponsored VTabl-SICD trial explored
among 32 patients the safety and efficacy of a novel hybrid
management strategy combining VT ablation with S-ICD implantation
in patients who have scar-related VT. Findings from the study
suggested that the combination strategy was superior to
conventional TV-ICD implantation for the secondary prevention of
sudden cardiac death by significantly reducing the need to deliver
ICD therapy and avoiding untreated, symptomatic
arrhythmias.
- At two years, the rate of delivery of any appropriate ICD
therapy was significantly lower in the VTabl-S-ICD group compared
to the TV-ICD group.
- There were no cases of untreated symptomatic VT or ventricular
fibrillation in the VTabl-S-ICD group.
Notable developments for the WATCHMAN FLX LAAC
Device
Data presented from two new sub-analyses of the SURPASS study out
of the National Cardiovascular Data Registry (NCDR) LAAO Registry
provided insights into real-world treatment strategies with the
WATCHMAN FLX LAAC Device. The first analysis assessed outcomes with
different post-procedural antithrombotic therapies and demonstrated
that patients treated with direct oral anticoagulants (DOAC) alone
had the lowest risk of major adverse events in comparison to other
drug regimens following the implant. The second analysis
demonstrated that concomitant catheter ablation and LAAC with the
WATCHMAN FLX device was safe and had similar outcomes when compared
to device implantation alone.
In addition, the latest preclinical data for the investigational
WATCHMAN FLX Pro LAAC Device demonstrated that its new
thromboresistant coating may further reduce the risk of
device-related thrombus and result in faster and more uniform
tissue coverage on the device at 45 days post implant. The findings
were also published in JACC Clinical Electrophysiology.
"The data shared at this year's Heart Rhythm meeting showcases
the breadth and depth of our cardiology therapies, which spans from
diagnosis to treatment of cardiac disease, and highlights the
continued growth of our portfolio," said Kenneth Stein, M.D., senior vice president and
global chief medical officer, Boston Scientific. "From preclinical
data to real-world surveillance, data demonstrated positive
outcomes for our FARAPULSE PFA System, the POLARx Cryoablation
System, the EMBLEM S-ICD System as well as our WATCHMAN FLX LAAC
device, and is evidence of our commitment to providing physicians
with innovative technologies that make a meaningful impact on the
lives of patients living with heart disease."
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 more than 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 on Twitter and Facebook.
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CONTACTS:
Steve Bailey
Media Relations
(651) 582-4343 (office)
Steve.Bailey@bsci.com
Lauren Tengler
Investor Relations
(508) 683-4479
BSXInvestorRelations@bsci.com
*Caution: Investigational Device. Limited by Federal (or US) law
to investigational use only. Not available for sale.
** Use of FARAPULSE in persistent AF patients is outside labeled
indications.
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SOURCE Boston Scientific Corporation