Medtronic (MDT) Gets Expanded FDA Nod for Cryoablation Catheters
Medtronic plc MDT announced the receipt of an expanded approval from the FDA for its Arctic Front Family of Cardiac Cryoablation Catheters to treat recurrent symptomatic paroxysmal atrial fibrillation (AF). Notably, the catheters are intended to be used as an early rhythm control strategy as a substitute to antiarrhythmic drug (AAD) therapy.
This is a major breakthrough within the company’s Cardiac Ablation Solutions business, which is part of its broader Cardiovascular portfolio.
Per Medtronic’s management, with this approval, Medtronic has the only ablation catheter approved by the FDA to be used as a first-line option to treat AF in the United States. The expanded indication shows Medtronic’s continuity to lead the way in cardiac ablation solutions for arrhythmia management.
Recently, the FDA expanded the indication for the company’s cryoablation therapy to include treating patients with drug refractory recurrent symptomatic paroxysmal and persistent atrial fibrillation.
More in the News
The FDA decision to expand the indication is based on results from a prospective, multi-centre, randomised STOP AF First trial, which enrolled 225 subjects at 24 sites across the United States.
The study showed greater efficacy of Medtronic’s cryoablation procedure for preventing atrial arrhythmia recurrence compared to the use of AAD therapy.
Per a study, around 74.6% of patients in the cryoballoon had successful treatment at one year compared to 45% in the AAD group. Further, a reduced rate of patient complications was observed while using catheter ablation as a first-line treatment.
Significance of Approval
The expanded FDA approval together with the increasing positive clinical evidence demonstrates cryoablation as a more effective solution for preventing atrial arrhythmia recurrence as a first-line treatment.
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With this new indication, physicians now have more options to treat AF earlier. Patients can now be referred for a cryoablation rather than trying drug therapy first to effectively control their AF, enabling them to get back to normal life without the added anxiety of progressing AF symptoms and potential health complications.
The Medtronic Arctic Front family of Cardiac Cryoablation Catheters is intended at supporting doctors in enhancing AF patient outcomes before drug failure and reducing the time from diagnosis to ablation with predictable outcomes.
Industry Prospects
Per a report by Global Market Insight, the global cardiac ablation market size was $2.8 billion in 2019 and is expected to reach $6.5 billion by 2026, at a CAGR of 13.1%.
Growing market demand for minimally-invasive technology and rising awareness among population for effective treatment alternatives including cardiac ablation is driving the market.
Recent FDA Approvals
In June 2021, Medtronic received the FDA approval for Vanta -- a high performance recharge-free implantable neurostimulator with a device life that can be optimized up to 11 years. Vanta utilizes Medtronic's proprietary AdaptiveStim technology for personalized pain relief.
In the same month, Medtronic announced the FDA approval and consequent first U.S. implants of its SenSight Directional Lead System. Notably, SenSight is a unique kind of Deep Brain Stimulation directional lead that for the first time combines the benefits of directionality with the power of sensing.
Price Performance
Shares of the company have gained 42.5% in a year’s time compared with the industry’s growth of 21%.
Zacks Rank and Key Picks
Currently, the company carries a Zacks Rank #3 (Hold).
A few better-ranked stocks from the broader medical space are Envista Holdings Corporation NVST, Inogen, Inc INGN and IDEXX Laboratories, Inc. IDXX, each carrying a Zacks Rank #2 (Buy). You can see the complete list of Zacks #1 Rank (Strong Buy) stocks here.
Envista Holdings has an estimated long-term earnings growth rate of 26%.
Inogen has an estimated long-term earnings growth rate of 33%.
IDEXX Laboratories has a projected long-term earnings growth rate of 20%.
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