- The Sphere-9 Catheter demonstrated a positive safety profile with an excellent primary safety endpoint rate of 1.4% (1.0% for the control arm). Importantly, no safety events including pulmonary vein stenosis, esophageal events or cardiac tamponade were reported. More than 95% of Sphere-9 procedures used a single transeptal puncture compared to 62% in the control arm.
- Sphere-9 demonstrated 73.8% freedom from AFib* vs. only 65.8% observed in the control arm. Following 100% acute isolation of pulmonary veins and linear lesions, patients treated with the Sphere-9 Catheter also observed less recurrence of atrial arrhythmias throughout the 12-month follow up period.
- Treatment with the Sphere-9 catheter demonstrated superior efficiency over the control arm for procedural characteristics including:
- Skin-to-skin procedural time
- Time between first and last ablation
- Energy application time
- Patients treated with the Sphere-9 catheter experienced improvements to quality of life in both mental and physical well-being.
Nisun International Regains Compliance With NASDAQ Minimum Bid Price Requirement
Nisun International Enterprise Development Group Co., Ltd (NASDAQ:NISN) ("Nisun" or the "Company") announced today that it has received a Staff determination letter (the "Letter") from
