Key Developments

In April 2024, AtriCure, Inc. a pioneer in surgical treatments for atrial fibrillation (Afib) and related conditions, has introduced the cryoSPHERE+ cryoablation probe. This new device utilizes advanced insulation technology to reduce freeze times by 25% compared to AtriCure’s previous cryoSPHERE device. Currently, the product is in an extended limited launch phase in the United States, with a full launch anticipated by the end of the second quarter.
In August 2023, Boston Scientific Corporation, biomedical/biotechnology engineering firm and multinational manufacturer of medical devices has received FDA approval for its POLARx Cryoablation System, designed for treating patients with paroxysmal atrial fibrillation (AF). This new system includes the POLARx FIT Cryoablation Balloon Catheter, which uniquely offers two balloon sizes (28mm and 31mm) within a single catheter.
In June 2021, Medtronic plc a leader in medical technology, has received expanded FDA approval for its Arctic Front Family of Cardiac Cryoablation Catheters. The approval allows for the treatment of recurrent symptomatic paroxysmal atrial fibrillation as an initial rhythm control strategy, offering an alternative to antiarrhythmic drug therapy.
In September 2023, IceCure Medical Ltd. has received regulatory approval from the Brazilian Health Regulatory Agency (ANVISA) for its ProSense System as a Class III medical device. This system utilizes minimally-invasive cryoablation technology to freeze and destroy tumors, offering an alternative to surgical removal. Previously registered as Class II devices, the ProSense System's disposable cryoprobes and introducers were also included in this updated approval.