Company Overview - Pulse Biosciences (PLSE) received FDA approval for its Investigational Device Exemption (IDE) to initiate the NANOCLAMP AF study, which evaluates its Nanosecond Pulsed Field Ablation (nsPFA) Cardiac Surgery System for atrial fibrillation (AF) [1][8] - The IDE approval is a significant growth catalyst for the company, validating its technology and enhancing its potential for broader clinical adoption in the cardiac ablation market [2][4] Market Position and Financials - PLSE currently has a market capitalization of $1.01 billion [6] - Following the announcement of the IDE approval, PLSE shares closed flat, with a year-to-date decline of 15.2%, compared to the industry's decline of 10.9% and the S&P 500's gain of 11.9% [3] Study Details - The NANOCLAMP AF study will involve up to 136 patients across 20 global sites, including two outside the United States, to evaluate the effectiveness of the nsPFA Cardiac Surgical System during concomitant cardiac surgeries [9][10] - Early clinical data from the EU indicate rapid and consistent ablation, with the device designed to minimize collateral tissue damage due to its nonthermal mechanism [10][11] Industry Prospects - The global atrial fibrillation market was estimated at $26.89 billion in 2024 and is projected to reach $65.33 billion by 2033, with a compound annual growth rate (CAGR) of 10.44% from 2025 to 2033 [12]

The FDA approval for expanded labeling was supported by clinical evidence from phase one of the ADVANTAGE AF clinical trial presented at AF Symposium 2025 and recently published in the Journal of the American College of Cardiology and met both the primary safety and effectiveness endpoints. In the prospective, single-arm trial, 260 patients who were drug intolerant to at least one Class I/III anti-arrhythmic drug (AAD) were enrolled at 43 global sites. There were no reported incidences of stroke, pulmonary ...

Core Insights - Medtronic announced positive clinical outcomes from studies on atrial fibrillation (AFib) patients using the Affera™ technologies, including the Sphere-360™ and Sphere-9™ catheters [1][6] Group 1: Sphere-360 Study - The Sphere-360 catheter demonstrated an 88% freedom from arrhythmia recurrence and 98% durable pulmonary vein isolation (PVI) in a one-year study [2] - No safety events were reported in the subgroup treated with the optimized waveform, highlighting the safety profile of the Sphere-360 [2] - The Sphere-360 catheter features a conformable lattice design and is integrated with the Affera Mapping and Ablation System, utilizing the smallest sheath in single-shot PFA technology at 8.5 Fr [2][3] Group 2: Sphere-9 Catheter - The Sphere-9 catheter was shown to safely create linear lesions in persistent AF patients, enhancing the chances of restoring normal heart rhythm [4] - This catheter is part of the Affera system, which received FDA approval in October 2024, indicating its efficacy in persistent AF treatment [4] Group 3: Medtronic's Position and Future Plans - Medtronic plans to initiate a U.S. pivotal trial for the Sphere-360 catheter later in the year, indicating ongoing commitment to innovation in AFib treatment [3] - The company is the only one offering two PFA solutions, with the PulseSelect™ system already available in over 30 countries, showcasing its leadership in the electrophysiology market [5] - Medtronic continues to expand the Affera system's availability globally, with current access in Europe, Australia, and New Zealand [5]