“And in the U.S., the FDA is reviewing our PulseSelect submission, and we expect to be one of the first companies with a PFA catheter in the U.S. market.”

In context

“leading the way in bringing pulse field ablation catheters to market in both the focal and single shot segments. In focal PFA, we continue to ramp manufacturing of the Sphere 9 catheter and remain in limited market release in Europe. Sphere 9 can perform both PFA and RF ablation and drives high density mapping all from the same catheter. And it integrates seamlessly with our differentiated Affera mapping system. In the U.S., we expect to complete the 12-month follow-up in the pivotal trial for Sphere 9 in the coming weeks, and then we'll prepare for FDA submission. In Single Shot PFA, we just received CE Mark for our PulseSelect catheter, and it will be commercially available early next calendar year. We are now the only company with approved catheters for both Single Shot and focal PFA. And in the U.S., the FDA is reviewing our PulseSelect submission, and we expect to be one of the first companies with a PFA catheter in the U.S. market. Now with our PFA catheters and the Affera Map/Nav system, combined with our leading Arctic front cryo solution and differentiated flex cath cross-transceptal system, we expect to drive strong long-term growth in the fast-growing $8 billion EP ablation space. Now turning to Structural Heart, overall the TAVR space continues to grow in the high-single, low-double-digit range. In Q2 we grew mid-single-digits, which was below the market. Now we declined slightly in the U.S., comping difficult prior year comparisons when we initially launched Evolut FX and customers purchased for stock. Yet we grew 4% sequentially, evidence of the strength of our product. In Europe, we grew high-single-digits and received CE mark for Evolut FX at the end of the quarter. And in Japan, we continued to win share”