“We do expect to improve from here as we roll-out the recently approved next-generation Nitron CryoConsole and PulseSelect, the only PFA catheter FDA-approved for both paroxysmal and persistent AF.”

In context

“10Fr bidirectional sheath. Clinicians are also reporting no noticeable muscle contraction with our PFA product, which is beneficial for patient experience. In focal, we continue to ramp manufacturing of the Affera Mapping System and Sphere9 catheter and remain in limited market release in Europe. Sphere9 is the only catheter that can perform both pulsed field ablation and radiofrequency ablation and high-density mapping. It's really an all-in-one catheter. In the US, our CAS business declined in the quarter. We faced the first full quarter of competition in the cryoablation space, which is a space we created and had been the only player. In addition, many customers actually held back purchases as they awaited the launch of our PulseSelect PFA catheter, which is now commercially available. We do expect to improve from here as we roll-out the recently approved next-generation Nitron CryoConsole and PulseSelect, the only PFA catheter FDA-approved for both paroxysmal and persistent AF. And in addition to the European feedback, clinicians have consistently commented on how well it's visualized and how easily it connects to their mapping system. So, we're also making progress in bringing our Affera Mapping System and Sphere9 catheter to the US. With the last patient follow up in our SPHERE Per-AF Pivotal Trial now completed. We expect to see the results at a medical meeting in the first half of this calendar year. With an $8 billion market size, expanding our share in this underpenetrated cardiac ablation space is a big opportunity for us. We expect our growth profile to improve over time. First, moving towards market growth and then winning share as we bring our rich pipeline of innovation to patients you need this technology. In neurovascular this quarter we grew high s”