AtriCure Announces the Launch of the cryoXT™ Device for Post-Operative Pain Management Following Amputation

New device expands AtriCure’s market opportunity in post-operative pain management while addressing a significant unmet clinical need

MASON, Ohio--(BUSINESS WIRE)--AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management, today announced the launch of the cryoXT^™ device, an innovative cryoablation technology used to help manage post-operative pain following amputation procedures.

Each year, over 185,000 amputations occur in the U.S., with approximately 60%¹ of patients experiencing residual limb pain and up to 85%² reporting phantom limb pain. AtriCure’s cryoICE^® platform uses a unique freezing method to block nerve pain signals. With the introduction of the cryoXT device, physicians now have access to a next-generation tool that brings this long-lasting approach to post-amputation pain management.

Recently cleared under an FDA 510(k), the cryoXT device is designed to temporarily block pain following amputation by ablating peripheral nerves. As part of the cryoICE^® platform, the cryoXT device builds on the proven safety and efficacy of AtriCure’s cryoSPHERE devices, which have been used in over 100,000 procedures since FDA clearance in November 2018. The device features a newly designed tip with multi-surface freezing technology to precisely target large diameter exposed peripheral nerves.

“The launch of the cryoXT device reflects our commitment to bringing meaningful, differentiated solutions to patients and providers in a significant and underserved segment of the surgical market,” said Michael Carrel, President and CEO of AtriCure. “We’re addressing a clear gap in post-amputation care by helping more patients successfully manage pain. It’s a powerful combination of doing good and expanding AtriCure’s growth pathways.”

“As an orthopedic surgeon, managing long-term pain after limb loss is a critical part of patient care,” said Dr. Bryan Houseman, DO, Orthopedic Surgeon at The Elliot Hospital in Manchester, NH. “The cryoXT device allows us to address pain at the time of surgery effectively, improving both recovery and quality of life, and represents a significant advancement in reducing post-surgical pain for our patients.”

1. https://journals.lww.com/pain/abstract/2021/07000/prevalence_of_residual_limb_pain_and_symptomatic.3.aspx#:~:text=The%20prevalence%20of%20RLP%20and%20symptomatic%20neuroma%20in%20patients%20who,providing%20timely%20and%20adequate%20management
2. https://www.ncbi.nlm.nih.gov/books/NBK448188/ 

About AtriCure

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 59 million people worldwide. Electrophysiologists, cardiothoracic and thoracic surgeons around the globe use AtriCure technologies for the treatment of Afib, reduction of Afib related complications, and post-operative pain management. AtriCure’s Isolator^® Synergy^™ Ablation System is the first medical device to receive FDA approval for the treatment of persistent and long-standing persistent Afib. AtriCure’s AtriClip^® Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure’s Hybrid AF^™ Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure’s cryoICE cryoSPHERE^® probes are cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on X @AtriCure.

Forward-Looking Statements

Certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Actual results may differ materially from those projected by any forward-looking statements. These risks and uncertainties include, but are not limited to, the following: our estimate of the market for our products; the rate and degree of market acceptance of our products; negative clinical data, including data that does not demonstrate sufficient safety and efficacy with respect to our products; the timing of and ability to obtain and maintain regulatory clearances and approvals for our products; our ability to comply with extensive FDA regulations; the timing of and ability to obtain third party payor reimbursement of procedures utilizing our products; the impact of tariffs or other restrictive trade measures; and litigation, administrative or other proceedings. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission ("SEC"), including our Annual Report on Form 10-K for the year ended December 31, 2024 filed with the SEC on February 14, 2025, and our quarterly reports on Form 10-Q. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.