Medtronic (NYSE:MDT) today released results from the Cryo4Persistent AF clinical trial of its Arctic Front Advance cryoablation system, touting reductions in the symptoms of abnormal heart rhythms and a low rate of re-interventions and repeat ablations.
The Fridley, Minn.-based company said it presented results from the trial at the 2018 European Society of Cardiology Congress in Munich this week.
“These findings highlight the advantage of cryoballoon ablation in patients with persistent AF, demonstrating that patients have fewer symptoms after treatment and a significant improvement in their quality of life. Paired with the study data showing a low incidence of reinterventions, it’s clear to see the benefit for both patients and healthcare providers,” study co-investigator Dr. K.R. Julian Chun of Frankfurt, Germany’s Agaplesion Markus Hospital said in a prepared statement.
Data from the 101-patient trial indicated that patients treated with cryoballoon ablation showed an average 7.1 point improvement in physical quality of life scores and a 3.3 point average improvement in mental health quality of life scores.
Patients who underwent cryballoon ablation also experienced a significant reduction in symptoms, with 92% experiencing symptoms including dizziness, palpitations and fatigue before the procedure and only 16% at one-year post procedure, Medtronic said.
Severity of symptoms also declined from 2.1 to 1.3 using the European Heart Rhythm Association AF symptom score. A total 47% of patients in the cryoballoon arm also showed NYHA class improvements of one or more functional classes at 12 months, the company said.
Only 17 of the 101 patients in the trial required a repeat ablation at the time of arrhythmia recurrence, and only eight patients underwent direct current cardioversion procedures. Only 3 patients in the trial remained antiarrhythmic medication at the end of the study, Medtronic said.
“The Cryo4Persistent AF study findings complement the growing body of clinical evidence that suggests cryoballoon ablation offers significant benefits to patients with AF even after the disease has progressed. At Medtronic, we’re focused on improving patient outcomes and quality of life, while offering greater efficiencies for physicians treating the growing number of AF patients today,” Medtronic AF solutions biz GM Rebecca Seidel said in a press release.
Last week, Medtronic posted fiscal first-quarter results that topped the consensus forecast on Wall Street and raised its sales outlook for the rest of fiscal 2019.