AtriCure, a leading company in the treatment of atrial fibrillation, announced today that its EnCompass cardiac tissue ablation clip has received the EU CE mark, meaning the device can be sold in more than 30 countries in the European Economic Area (EEA).

A number of innovative products were launched

AtriCure was founded in 2000 and focuses on cardiac surgery solutions. The company mainly produces and sells cardiac ablation devices, providing innovative technologies for the treatment of atrial fibrillation and related diseases. At present, AtriCure has 138 authorized patents in the United States and has served more than 300,000 patients with atrial fibrillation since 2004.

It is understood that the EnCompass cardiac tissue ablation clamp is used for cardiac tissue ablation surgery, including comprehensive epicardial ablation of the left atrium during open heart surgery. This is a simpler and faster method of open-chest cardiac ablation, allowing doctors to perform comprehensive epicardial ablation of the left atrium in just a few minutes.

In addition to simplifying the surgical process, the EnCompass clamp also has innovative breakthroughs in technology. The product includes the features of AtriCure's existing Synergy™ clamp series, such as parallel closure, uniform pressure, and customized power using Synergy radio frequency (RF). In addition, the EnCompass clamp is also equipped with a magnetic guide placement function, which allows for easier placement using a magnetic guide, which can achieve more efficient surgery by minimizing tissue dissection.

In addition, the EnCompass clip is designed to adapt to the anatomy of the heart, supporting ablation in surgeries where the atrium is not usually opened, such as CABG (coronary artery bypass grafting) and AVR (aortic valve repair). The product has previously been approved by the US FDA 510 (K) and will be launched in the United States in 2022.

It is reported that European surgeons recently completed the treatment of the first cases using the device. AtriCure estimates that approximately 400,000 heart surgeries are performed in the European Union each year, indicating that the EnCompass clip has huge market potential. AtriCure's technologies, including the FDA-approved Isolator® Synergy™ ablation system for the treatment of persistent atrial fibrillation and the widely sold AtriClip® left atrial appendage closure system (global sales champion), have been widely adopted by surgeons and cardiac electrophysiologists around the world.

Among them, the Isolator® Synergy™ ablation system is the first and only medical device approved by the US FDA for the treatment of long-term persistent atrial fibrillation. The product has provided surgical ablation treatment for atrial fibrillation to 200,000 patients worldwide in the past decade.

It is worth mentioning that the AtriClip® Left Atrial Appendage Closure System is the most widely used left atrial appendage closure device in the world. This global sales champion product was approved in China in July this year. The system is suitable for left atrial appendage closure under direct vision and can be performed simultaneously with other cardiac surgeries. It also has many features such as 12 mm port compatibility, open design clip, and tip-first closure.

AtriCure stated that the AtriClip® Left Atrial Appendage Closure System was approved in China based on its excellent clinical data, which proved the safety and effectiveness of the system. To date, the system has been successfully used in more than 550,000 patients worldwide. After approval, AtriCure plans to cooperate with leading medical institutions and professionals in China to provide training and support, and looks forward to working with Chinese regulators to introduce more products.

Performance continues to improve

As a medical device company focusing on cardiac surgery solutions, AtriCure's atrial fibrillation solutions mainly consist of three parts: open surgical ablation, minimally invasive surgical ablation and left atrial appendage closure management. In addition, AtriCure is also actively developing pain management treatment to expand its product pipeline.

In addition to the above-mentioned open & minimally invasive ablation products Isolator® Synergy™ ablation system, EnCompass clamp and left atrial appendage closure product AtriClip® left atrial appendage closure system, AtriCure also has:

Open ablation products: cryoICE Cryoablation System, used for open atrial fibrillation ablation surgery and cryoanalgesia;

Minimally invasive ablation products: EPi-Sense Systems, a disposable radiofrequency ablation device that can sense and record cardiac signals during surgery, while using monopolar radiofrequency energy for tissue coagulation. In 2021, EPi-Sense® was approved by the FDA for the treatment of patients with systemic, drug-refractory, long-term persistent Afib. In 2022, EPi-Sense ST® was approved by the FDA. Hybrid AF therapy is the only FDA-approved minimally invasive procedure for the treatment of patients with long-term persistent Afib;

Pain management products: cryoSPHERE The probe is used by cardiothoracic or thoracic surgeons during surgery. It applies cryogenic energy to the targeted intercostal peripheral nerves in the chest cavity to temporarily ablate the peripheral nerves, thereby controlling pain within 90 days after surgery. The product has obtained 510 (k) clearance and CE mark.

Judging from the company's semi-annual report, the field it focuses on has maintained a steady growth this year. In the first half of 2024, AtriCure achieved revenue of US$225.1 million, a year-on-year increase of 15.8%, and its revenue in domestic and foreign markets was also very impressive. Among

them, the US market business revenue was US$185.8 million, a year-on-year increase of 14.9%, and the growth trend of the four major areas was stable:

open ablation business revenue was US$60.1 million, a year-on-year increase of 15.2%;

minimally invasive ablation business revenue was US$24.1 million, a year-on-year increase of 14.9%;

pain management business revenue was US$27.7 million, a year-on-year increase of 17.3%;

left atrial appendage closure business revenue was US$73.8 million, a year-on-year increase of 11.4%.

Its international market business has made a significant breakthrough this year, with revenue of US$39.3 million, a year-on-year increase of 25.6%, mainly due to the substantial growth of pain management business:

open ablation business revenue was US$17.1 million, a year-on-year increase of 13.8%;

minimally invasive ablation business revenue was US$3.9 million, a year-on-year increase of 19.6%;

pain management business revenue was US$2.2 million, a year-on-year increase of 226.5%;

left atrial appendage closure business revenue was US$16.2 million, a year-on-year increase of 30.6%.
Currently, AtriCure is also continuing to expand in the Chinese market. In addition to the approval of a number of star products in China, in June 2018, AtriCure has reached a strategic cooperation agreement with Baiyang Pharmaceutical on atrial fibrillation solutions. Qingdao Baiyang Pharmaceutical Co., Ltd., a subsidiary of Baiyang Pharmaceutical Group, will become the exclusive agent and distributor of AtriCure's atrial fibrillation surgical ablation medical devices in China, providing services to more than 10 million Chinese patients suffering from the disease.

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