Medtronic's Heart Catheter Achieves Safety And Efficacy Goals In Patients With Irregular Heartbeat

On Friday, Medtronic plc MDT released results from the SPHERE Per-AF study comparing Sphere-9 to the conventional Thermocool SmartTouch SF radiofrequency ablation catheter with the Carto 3 System.

The findings were presented as late-breaking clinical data at the Heart Rhythm Society 2024 Annual Meeting and published in Nature Medicine.  

The study demonstrated the safety and efficacy of the Affera Mapping and Ablation System with Sphere-9 Catheter, an all-in-one pulsed field (PF) and radiofrequency (RF) ablation and high-density (HD) mapping catheter for persistent atrial fibrillation (AFib). 

Atrial fibrillation (AFib) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure, and other heart-related complications. 

Related: Medtronic’s Latest Generation Of Transcatheter Aortic Valve Replacement Implant Passes FDA’s Muster, Shares Gain.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide.

The Sphere-9 Catheter demonstrated a favorable safety profile with a primary safety endpoint rate of 1.4% (1.0% for the control arm). 

No safety events were reported, including pulmonary vein stenosis, esophageal events, or cardiac tamponade. 

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.
• The time between the first and last ablation.
• Energy application time.

Patients treated with the Sphere-9 catheter experienced improvements in quality of life.

Read Next: Medtronic Recalls Neurosurgery Catheter Tubing, FDA Identifies As Serious Recall.

Price Action: MDT shares are down 1.45% at $84.67 at last check Monday.

Photo by Tony Webster via Wikimedia Commons