Medtronic is lining up another PFA cardiac ablation system for approval, while competitor Boston Scientific anticipates approval of its Farapulse PFA system sometime in 2024. Meanwhile, Johnson & Johnson’s Biosense Webster is testing its ThermoCool SmartTouch SF system for both PFA and radiofrequency ablation.
Medtronic EVP and Cardiovascular President Sean Salmon recently discussed PFA technology in an interview with Medical Design & Outsourcing before the world’s largest medical device manufacturer announced the PulseSelect approval.
“The whole promise of pulsed field is it can be faster, safer, and at least as efficacious as what you can do with thermal ablation today,” he said.
An estimated 60 million people are affected by AFib, which is a progressive disease that can increase the risk of heart failure, stroke and death. The FDA designated Medtronic’s PFA systems (as well as Boston Scientific’s Farapulse) as breakthrough devices for the potential to more effectively treat serious conditions like AFib.
“There’s a huge opportunity because it’s a $9 billion market that’s way underpenetrated — there’s about 5% penetration — and it’s growing double digits right now,” Salmon said. “We have a great opportunity to enter that market with highly differentiated technologies that can have a lot of growth for us for many years to come, and of course, help a lot of patients.”
Medtronic’s PulseSelect system can be used by itself, with mapping or navigation platforms manufactured by other firms, or used with Medtronic’s Affera technology.
Related: Why Affera’s cardiac ablation technology is worth $1B to Medtronic
Affera’s system combines high-density mapping, navigation and ablation. Affera’s Sphere-9 catheter is a point-by-point ablation catheter with the ability to delivery both radiofrequency and pulsed field energy, with a foot pedal allowing the cardiologist to control the energy delivery.
Read more at Medical Tubing & Extrusion sister publication Medical Design & Outsourcing.
