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

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AtriCure, Inc. (Nasdaq: ATRC) has announced the launch of the cryoSPHERE+ cryoablation probe, aimed at post-operative pain management. The new device reduces freeze times by 25% compared to the previous model, enhancing patient care and procedural efficiency. With FDA clearance for pain management in adult and adolescent patients, the cryoSPHERE+ leverages innovative technology to improve outcomes and streamline procedures. The product is currently in a launch phase in the US, with a full rollout expected by the end of the second quarter.
AtriCure, Inc. (Nasdaq: ATRC) ha annunciato il lancio della sonda criogenica cryoSPHERE+, destinata alla gestione del dolore post-operatorio. Il nuovo dispositivo riduce i tempi di congelamento del 25% rispetto al modello precedente, migliorando l'assistenza al paziente e l'efficienza procedurale. Con l'autorizzazione della FDA per la gestione del dolore in pazienti adulti e adolescenti, la cryoSPHERE+ sfrutta una tecnologia innovativa per migliorare i risultati e razionalizzare le procedure. Il prodotto è attualmente in fase di lancio negli Stati Uniti, con un'implementazione completa prevista entro la fine del secondo trimestre.
AtriCure, Inc. (Nasdaq: ATRC) ha anunciado el lanzamiento de la sonda de crioterapia cryoSPHERE+, dirigida al manejo del dolor postoperatorio. El nuevo dispositivo reduce los tiempos de congelación en un 25% en comparación con el modelo anterior, mejorando el cuidado del paciente y la eficiencia del procedimiento. Con la aprobación de la FDA para el manejo del dolor en pacientes adultos y adolescentes, el cryoSPHERE+ aprovecha la tecnología innovadora para mejorar los resultados y optimizar los procedimientos. El producto está actualmente en una fase de lanzamiento en EE. UU., con una implementación completa esperada para finales del segundo trimestre.
AtriCure, Inc. (나스닥: ATRC)는 수술 후 통증 관리를 위한 cryoSPHERE+ 동결 절제 프로브 출시를 발표했습니다. 이 새로운 장치는 이전 모델에 비해 동결 시간을 25% 단축시켜 환자 치료와 절차 효율성을 향상시킵니다. 성인 및 청소년 환자의 통증 관리에 대한 FDA 승인을 받은 cryoSPHERE+는 혁신적인 기술을 활용하여 결과를 개선하고 절차를 간소화합니다. 현재 미국에서 출시 단계에 있으며, 2분기 말까지 전면 배포가 예상됩니다.
AtriCure, Inc. (Nasdaq : ATRC) a annoncé le lancement de la sonde de cryoablation cryoSPHERE+, destinée à la gestion de la douleur postopératoire. Le nouvel appareil réduit les temps de congélation de 25 % par rapport au modèle précédent, améliorant ainsi les soins aux patients et l'efficacité de la procédure. Avec l'autorisation de la FDA pour la gestion de la douleur chez les patients adultes et adolescents, le cryoSPHERE+ utilise une technologie innovante pour améliorer les résultats et simplifier les procédures. Le produit est actuellement en phase de lancement aux États-Unis, avec un déploiement complet prévu pour la fin du deuxième trimestre.
AtriCure, Inc. (Nasdaq: ATRC) hat den Start der cryoSPHERE+ Kryoablations-Sonde bekannt gegeben, die für das postoperative Schmerzmanagement vorgesehen ist. Das neue Gerät verkürzt die Gefrierzeiten um 25% im Vergleich zum Vorgängermodell, was die Patientenversorgung und die Effizienz des Verfahrens verbessert. Mit der FDA-Zulassung für Schmerzmanagement bei erwachsenen und jugendlichen Patienten nutzt die cryoSPHERE+ innovative Technologie, um Ergebnisse zu verbessern und Prozesse zu optimieren. Das Produkt befindet sich derzeit in der Einführungsphase in den USA, wobei eine vollständige Markteinführung bis zum Ende des zweiten Quartals erwartet wird.
Positive
  • The launch of the cryoSPHERE+ probe by AtriCure is a significant step towards enhancing patient care and procedural efficiency.
  • The new device reduces freeze times by 25% compared to the previous model, allowing for quicker procedures and improved outcomes.
  • FDA clearance for pain management in both adult and adolescent patients highlights the versatility and effectiveness of the cryoSPHERE+ technology.
  • Physicians and surgeons have praised the new device for its innovative technology that minimizes thermal loss and enhances procedural ease.
  • The cryoSPHERE+ is expected to have a positive impact on post-operative pain management strategies, potentially reducing opioid use and improving patient outcomes.
Negative
  • None.

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 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

Angie Wirick

Investor Relations

Chief Financial Officer

(513) 755-5334

awirick@atricure.com

Valerie Storch-Willhaus

Media Relations

Vice President, Corporate Marketing & Communications

(612) 605-3311

vstorch-willhaus@atricure.com

Source: AtriCure, Inc.

FAQ

What is the ticker symbol for AtriCure, Inc.?

The ticker symbol for AtriCure, Inc. is ATRC.

What is the cryoSPHERE+ cryoablation probe launched by AtriCure?

The cryoSPHERE+ cryoablation probe is a new device aimed at post-operative pain management, reducing freeze times by 25% compared to the previous model.

What technology does the cryoSPHERE+ device leverage?

The cryoSPHERE+ device leverages new insulation technology to reduce freeze times and focuses energy at the ball tip for faster therapeutic temperature.

What FDA clearance has the cryoSPHERE+ device received?

The cryoSPHERE+ device has 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.

What are the potential benefits of using the cryoSPHERE+ device?

The cryoSPHERE+ device offers reduced freeze times, improved procedural efficiency, and enhanced pain management strategies, potentially reducing opioid use post-operatively.

Who praised the cryoSPHERE+ device for its innovative technology?

Dr. Mario Gasparri, Cardiothoracic Surgery at Froedtert & the Medical College of Wisconsin, Milwaukee, WI, praised the cryoSPHERE+ device for its new technology that reduces energy loss and freeze times.

What is the impact of AtriCure's cryoICE platform technology on post-operative pain management?

AtriCure's cryoICE platform technology uses a unique freezing method to block nerves from transmitting pain signals for several months, potentially reducing opioid use and improving patient outcomes.

What percentage of lung surgery patients become new persistent opioid users post-surgery?

According to The Society of Thoracic Surgeons, 1 in 7 lung surgery patients (14%) become new persistent opioid users after surgery, highlighting the importance of effective pain management strategies like Cryo Nerve Block therapy.

What is the current status of the cryoSPHERE+ device launch?

The cryoSPHERE+ device is currently in an extended launch period in the United States, with a full launch expected by the end of the second quarter.

AtriCure, Inc.

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About ATRC

atricure, inc. provides innovative technologies for the treatment of afib and related conditions. afib affects more than 33 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 and only 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, with more than 100,000 implanted to date. for more information, visit atricure.com or follow us on twitter @atricure.