Biosense Webster has launched the Biosense Webster Advantage programme, an outcomes-based, risk-sharing program for US hospitals that reinforces the significant patient benefits demonstrated by the company’s ThermoCool SmartTouch Catheter. This is the first therapy approved by the US Food and Drug Administration (FDA) to enable direct and real-time measurement of contact force during catheter ablation and the only integrated catheter in the world that can provide stability of contact force.
All US-based hospitals are eligible to participate in the Biosense Webster Advantage programme and enrolment is open to patients with paroxysmal, drug-resistant atrial fibrillation treated with the ThermoCool SmartTouch Catheter. Participating hospitals will be guaranteed a credit if an enrolled patient returns for a repeat procedure within 12 months.
“This novel programme is backed by our confidence in the ThermoCool SmartTouch Catheter, which is seamlessly integrated with our Carto SmartTouch 3D Module, and has demonstrated compelling clinical outcomes in our SMART-AF trial that studied this therapy,” said David Shepherd, worldwide president of Biosense Webster.
“Biosense Webster’s risk-sharing programme demonstrates the company’s commitment to exploring unique partnerships with hospitals as we look to optimise clinical outcomes, decrease cost and enhance the overall patient experience,” said Reginald Blaber, executive director and vice president of cardiovascular services at Lourdes Health System, USA. “This novel program facilitates easier access to this latest treatment advancement as it mitigates some of the economic risk we traditionally absorbed on our own.”
The SMART-AF trial evaluated the safety and effectiveness of the ThermoCool SmartTouch Catheter in patients with drug-resistant paroxysmal atrial fibrillation. One-year results from the trial, recently published in the Journal of the American College of Cardiology, showed patients experienced an overall success rate of 74%. Importantly, a sub-analysis from the trial demonstrated an 88% success rate when contact force was within an investigator-selected range greater than or equal to 85% of time. This trial demonstrated for the first time that stability of contact force therapy helps to significantly improve outcomes for patients undergoing catheter ablation. This data reinforces the growing body of clinical evidence demonstrating that stability of contact force helps physicians deliver tailored treatment with precision and accuracy, ensuring very positive clinical outcomes.
“The ThermoCool SmartTouch Catheter has set a new standard in cardiac arrhythmia management by providing the confidence that every location I need to ablate is effectively treated the first time,” said Craig Delaughter, HeartPlace Baylor All Saints, USA. “This therapy represents a significant advancement as it has proven results in improving clinical outcomes for patients with atrial fibrillation and helping them get back to their lives.”
The ThermoCool SmartTouch Catheter was approved by the FDA in February 2014 and is indicated for patients suffering from drug-resistant paroxysmal atrial fibrillation, sustained monomorphic ischaemic ventricular tachycardia and type I atrial flutter.