Abbott Shares Rise on FDA Approval of New Heart Rhythm Device
The Volt PFA System enters a competitive, fast-growing market for atrial fibrillation treatment, challenging rivals Boston Scientific and Medtronic.
Abbott Laboratories (NYSE: ABT) shares gained ground after the company announced it received U.S. Food and Drug Administration (FDA) approval for its Volt™ Pulsed Field Ablation (PFA) System to treat atrial fibrillation (AFib), the most common heart rhythm disorder.
Shares of the $218 billion medical technology company rose nearly 1% to $126.64 in Monday trading following the news. The approval positions Abbott to compete in one of the fastest-growing segments of the medical device market and offers a new treatment option for the estimated 12 million people in the U.S. living with AFib.
The Volt system is designed to treat both paroxysmal (intermittent) and persistent AFib. It uses high-energy electrical pulses to isolate the pulmonary veins, where irregular heart signals that cause the condition often originate. This technology, known as PFA, is seen as a significant advancement over traditional thermal ablation, which uses heat or cold to destroy tissue and carries risks of damaging surrounding structures like the esophagus or nerves.
Abbott's device features a unique balloon-in-basket catheter, designed to conform to varying anatomies and deliver proportional, targeted energy pulses for safer and more efficient procedures.
"The approval of our Volt PFA System is a pivotal moment in the treatment of atrial fibrillation, offering a safer and more effective solution that we believe will become the new standard of care," said a company representative in its official announcement. The company highlighted the system's potential to shorten procedure times and reduce recovery periods for patients.
This approval intensifies the competition in the cardiac ablation market, which has seen a flurry of activity. The global PFA market was valued at approximately $2.28 billion in 2024 and is projected to see explosive growth. Recent industry analysis suggests physicians expect to use PFA technology in nearly half of all AFib ablation procedures in the coming year, a significant increase from an estimated 39% in 2024.
Abbott now enters a field with formidable competitors. Medtronic has already seen substantial revenue growth from its Affera Sphere-9 PFA system, which helped drive a 71% increase in its cardiac ablation solutions unit last quarter. Similarly, Boston Scientific recently gained a CE Mark in Europe for its FARAPOINT PFA Catheter, signaling its own global ambitions in the space.
The approval provides a crucial catalyst for Abbott's extensive cardiac rhythm management division, a key component of its broader medical devices business. Wall Street has maintained a broadly positive outlook on the company, with 21 analysts holding a "buy" or "strong buy" rating. The consensus 12-month price target for Abbott stock sits at $144.43, suggesting analysts see further potential for upside even as the stock trades near its 52-week high of $139.33.