AtriCure Announces Launch of the cryoSPHERE®+ Probe for Post-Operative Pain Management

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 that it has launched the cryoSPHERE^®+ cryoablation probe, leveraging new insulation technology to reduce freeze times by 25% versus AtriCure’s legacy cryoSHPERE^® device. The product is currently in an extended limited launch period in the United States, with full launch expected by the end of the second quarter.

“cryoSPHERE+ is a meaningful innovation that I believe will improve patient care, enhance outcomes, and enable physicians to perform procedures with greater ease and confidence,” said Michael Carrel, President and Chief Executive Officer at AtriCure. “Since the launch of our pain management franchise over five years ago, we’ve seen a significant impact on patient’s lives, and with this launch, we look forward to serving even more people in the future.”

The cryoSPHERE+ device, a part of the cryoICE ^® platform, is built upon the proven safety and efficacy of the cryoSPHERE device, which was cleared in November 2018 and has been used in over 60,000 procedures to date. The cryoSPHERE+ received FDA 510(k) clearance for temporarily blocking pain by ablating peripheral nerves in adult patients, and by ablating intercostal nerves under direct visualization in adolescent patients (12-21 years of age). The cryoSPHERE+ device leverages new technology, which minimizes thermal loss by focusing energy at the ball tip, which provides a faster time to therapeutic temperature. This allows for a reduction in freeze time by 25%, which reduces operative time.

“The cryoSPHERE+ includes new technology that reduces energy loss for reduced freeze times, and a more rigid shaft which is important for applying consistent pressure during the procedure,” said Dr. Mario Gasparri, Cardiothoracic Surgery, Froedtert & the Medical College of Wisconsin, Milwaukee, WI. “Being able to get procedures done more quickly, when making multiple ablations on a single patient, is a huge advantage.”

According to The Society of Thoracic Surgeons, 1 in 7 lung surgery patients (14%) became new persistent opioid users after surgery, which establishes opioid addiction as a common post-operative complication.¹ AtriCure’s cryoICE platform technology uses a unique freezing method to block nerves from transmitting pain signals for several months. Because of its long-lasting nature, physicians are adopting Cryo Nerve Block therapy using cryoSPHERE as part of their multi-modal pain management strategy.

“The cryoSPHERE+ is perfect for my workflow, and the new technology means one less thing for me to think about during the procedure.” said Dr. Scott Goldman, Cardiac Surgery, Main Line Health, Wynnewood, PA. “This new product is going to be a game changer for my practice.”

Forward-Looking Statements

This press release contains “forward-looking statements”– that is, statements related to future events that by their nature address matters that are uncertain. Actual results could differ materially. For details on the uncertainties that may cause our actual results to be materially different than those expressed in our forward-looking statements, visit http://www.atricure.com/forward-looking-statements as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which contain risk factors. We assume no obligation to update any forward-looking statements contained in this release and the related attachment as a result of new information or future events or developments, except as may be required by law.

About AtriCure

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 37 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure’s Isolator® Synergy™ Ablation System is the first medical device to receive FDA approval for the treatment of 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 Twitter @AtriCure.

¹The Society of Thoracic Surgeons. (2018). 1 in 7 Lung Surgery Patients at Risk for Opioid Dependence [Press release]. Retrieved from http://sts.org/sites/default/files/press-releases/Opioid_Brescia_FINAL%20FMTb.pdf

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