AtriCure, Inc. (AtriCure) engages in the development, manufacture, and sale of devices used by cardiothoracic and thoracic surgeons in surgical procedures, designed primarily for the surgical ablation of cardiac tissue, the exclusion of the left atrial appendage, and to block pain by temporarily ablating peripheral nerves. The company operates as an innovator in treatments for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management.
The company’s ca...
AtriCure, Inc. (AtriCure) engages in the development, manufacture, and sale of devices used by cardiothoracic and thoracic surgeons in surgical procedures, designed primarily for the surgical ablation of cardiac tissue, the exclusion of the left atrial appendage, and to block pain by temporarily ablating peripheral nerves. The company operates as an innovator in treatments for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management.
The company’s cardiac ablation and left atrial appendage management (LAAM) products are used by physicians during open-heart and minimally invasive surgical procedures. In open-heart procedures, the patient is undergoing heart surgery for other conditions, such as a mitral or aortic valve repair or a coronary artery bypass, and the company’s products are used by physicians in conjunction with (‘concomitant’ to) such a procedure. Minimally invasive procedures are performed on a standalone basis, and often include multi-disciplinary or ‘hybrid’ approaches, combining surgical procedures using the company’s ablation and LAAM products with catheter ablation performed by an electrophysiologist.
The company’s pain management solutions are used by physicians to freeze nerves during cardiothoracic or thoracic surgical procedures. Recovery from cardiothoracic and thoracic surgery can be complicated and painful. Many surgeons use multiple pain management strategies that include oral delivery of opioid and non-opioid pain medications. The company’s cryoICE cryoSPHERE probes for pain management (known as Cryo Nerve Block) provides temporary relief of post-operative pain, allowing the patient's body to heal after surgery while the nerves regenerate and sensation is regained.
The company sells its products to medical centers through its direct sales force in the United States, Germany, France, the United Kingdom, the Benelux region, Canada and Australia. The company also sells its products through distributors who in turn sell its products to medical centers in other international markets. The company’s business is primarily transacted in U.S. Dollars; direct sales transactions outside the United States are transacted in Euros, British Pounds, Canadian Dollars or Australian Dollars.
AtriCure Solutions and Products
The company is the market leader in the surgical treatment of Afib and LAAM, and pioneers of the application of Cryo Nerve Block in cardiothoracic surgical procedures. The company anticipates that substantially all its revenue for the foreseeable future will relate to products its sell or are in the process of developing. The company’s products enable cardiothoracic surgeons to perform surgical ablation procedures with faster, less invasive and less technically challenging approaches and clinically proven results. The company’s completed, and continue to invest in, clinical studies for the use of its ablation and LAAM products to treat Afib, reduce post-operative Afib, and prevent strokes. Leading cardiothoracic surgeons and electrophysiologists, including those who serve or who have served as consultants to the company, has published results of preclinical and clinical studies utilizing its devices. The results of these studies have assessed efficacy, ease of use and safety endpoints.
Products for cardiac tissue ablation include those that create scar tissue using radio frequency (RF) energy or cryogenic (cryo) modalities. The company’s ablation products are part of platforms, each consisting of disposable hand pieces which connect to either a RF generator or a cryo generator.
Products for open and minimally invasive ablation:
Isolator Synergy Clamps: The company’s Isolator Synergy Ablation System clamps are single-use disposable RF products with jaws that close in a parallel fashion. The system consists of the clamp and an RF generator. The company sells multiple configurations of its Isolator Synergy clamps. The various configurations provide the user with options to address patient specific procedure requirements or anatomy; however, all the clamps provide consistent performance using the same core technology. The parallel closure evenly compresses tissue and evacuates the blood and fluids from the energy pathway to make the ablation more effective. The Isolator Synergy Ablation System has been studied in multiple FDA approved clinical trials, including the previously completed ABLATE clinical trial which supported a pre-market approval (PMA) in 2011, as well as the ongoing DEEP AF IDE and HEAL-IST clinical trials.
The company’s Isolator Synergy Ablation System includes multiple configurations approved by the United States Food and Drug Administration (FDA) for the treatment of persistent and long-standing persistent Afib concomitant to other open-heart surgical procedures. Certain products within the company’s Isolator Synergy clamp line are in compliance with the European Union Medical Device Regulations (EU MDR) and bear the CE mark for commercial distribution throughout the member states of the European Union (EU) and other countries that comply with or mirror EU MDR. These products are available for sale in a number of other countries globally.
In 2022, the company launched the EnCompass clamp in the United States, following 510(k) clearance in 2021. The EnCompass clamp is indicated for cardiac soft tissue ablation and is designed to make concomitant surgical ablations more efficient and is expected to drive deeper penetration of cardiac surgery procedures. In 2024, the company received 510(k) clearance for its most recent configuration of the Isolator Synergy platform, the EnCapture clamp, which has enhanced geometry and features to facilitate engagement with the intended cardiac tissue.
Multifunctional Pens and Linear Ablation Devices: These devices are single-use disposable RF products that come in multiple configurations. Surgeons generally use one or more of the company’s pen and linear devices in combination with Isolator Synergy clamps. The company’s pen and linear ablation devices are cleared for sale in the United States under FDA 510(k) clearances, with indications for the ablation of cardiac tissue and/or the treatment of cardiac arrhythmias. Certain configurations of the company’s pen and linear ablation devices are also cleared or approved for sale outside of the United States.
Products for Open Ablation
cryoICE Cryoablation System: The cryoICE cryoablation system is used in both open ablation procedures and cryoanalgesia for post-operative pain management. The system consists of the cryoICE BOX generator along with a variety of single-use disposable probes. The primary differences between these cryoablation probes are the form of the tissue-contacting distal end. The various configurations of cryoICE devices enable the user to make linear ablations of varied length, providing the surgeon with options to address the specific procedural objectives. Surgeons may utilize the cryoICE devices in combination with Isolator Synergy clamps or independently.
The company’s cryoablation devices are cleared for sale in the United States under FDA 510(k) clearances and are in compliance with EU MDR and bear the CE mark for commercial distribution throughout the member states of the EU and other countries that comply with or mirror EU MDR. These products are available for sale in a number of other countries globally.
The ICE-AFIB clinical trial is studying the safety and efficacy of the cryoICE system for persistent and long-standing persistent Afib treatment during concomitant on-pump cardiac surgery.
Products for Minimally Invasive Ablation
EPi-Sense Systems: The EPi-Sense Guided Coagulation System and the EPi-Sense ST Guided Coagulation System utilize monopolar RF energy for the coagulation of tissue. The system consists of the device and an RF generator. The company’s EPi-Sense devices are single-use disposable ablation devices capable of intraoperative cardiac signal sensing and recording when connected to an external recording device.
The company’s EPi-Sense System was studied through the CONVERGE clinical trial and approved in 2021 by FDA for the treatment of patients with systemic, drug refractory, long-standing persistent Afib when augmented with an endocardial ablation catheter. The company’s EPi-Sense ST Guided Coagulation System was approved via PMA supplement in late 2022. Hybrid AF Therapy is the only FDA-approved minimally invasive procedure to treat patients with long-standing persistent Afib and represents a proven option for patients with this advanced disease.
Products for Pain Management
cryoSPHERE probes: The cryoSPHERE probe is used to apply cryogenic energy to targeted intercostal peripheral nerves in the ribcage in order to provide temporary pain relief. This technique, called Cryo Nerve Block, is applied intraoperatively by cardiothoracic or thoracic surgeons and results in temporary pain relief for up to 90 days after the procedure. Sensation typically returns to the affected region of the chest after this period. Scientific data that has been published on the effects of Cryo Nerve Block therapy has generally shown a significant reduction in prescription of opioids, significantly reduced length of stay for patients in the hospital and reduced healthcare utilization costs. The cryoSPHERE probe is 510(k) cleared for managing pain by temporarily ablating peripheral nerves and is in compliance with EU MDR and bears the CE mark for commercial distribution throughout the member states of the EU and other countries that comply with or mirror EU MDR.
During 2024, the company launched two new cryoSPHERE probes for pain management in the United States. The cryoSPHERE cryoablation probe leverages new technology that minimizes thermal loss by focusing energy at the ball tip, allowing for a reduction in freeze time by 25%. The cryoSPHERE MAX probe features a larger ball tip, designed to optimize Cryo Nerve Block therapy. The cryoSPHERE MAX probe reduces freeze times by 50% when compared to the first-generation cryoSPHERE cryoablation probe, and over 30% when compared to the cryoSPHERE+ probe.
Products for Appendage Management
AtriClip System: The AtriClip LAA Exclusion System includes various combinations of an implantable device (AtriClip) coupled to a single-use disposable applier. The AtriClip device is designed to exclude the left atrial appendage by mechanically clamping the appendage from the outside of the heart. In addition to the risk of blood clots originating in the left atrial appendage, the left atrial appendage has also been shown to be a source of arrhythmias. The exclusion of the LAA eliminates blood flow between the left atrial appendage and the atrium while avoiding contact with circulating blood and provides electrical isolation benefits after placement. The company’s AtriClip system is safer, more effective and easier to use than other techniques for permanently excluding the left atrial appendage. The device comes in two geometries: a rectangular configuration which encircles the targeted tissue and a ‘V’ shape which allows for an alternative lateral access, and a variety of lengths which are matched to each patient's anatomy. The appliers come in multiple forms tailored to specific procedural needs depending on the type of surgery and how the surgeon is accessing the heart.
In the United States, the company’s AtriClip LAA Exclusion System products are 510(k)-cleared with an indication for the exclusion of the LAA, performed under direct visualization and in conjunction with other cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon can see the heart directly, with or without assistance from a camera, endoscope or other appropriate viewing technologies. Certain products of the company’s AtriClip LAA Exclusion System are in compliance with EU MDR and bear the CE mark for commercial distribution throughout the member states of the EU and other countries that comply with or mirror EU MDR. These products are available for sale in a number of other countries globally.
During 2024, the company launched the newest generation AtriClip, the AtriClip FLEX-Mini device, in the United States. The AtriClip FLEX-Mini sets a new standard as the smallest profile for a surgical LAA device on the market and builds upon the proven technology and clinical benefits of the company’s AtriClip platform, with ease of use and design simplicity that offers enhanced access and increased visibility for physicians.
The AtriClip LAA Exclusion System is being evaluated under the Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) IDE clinical trial.
The company sells additional products and enabling technologies that hold 510(k) approvals, and certain products are in compliance with EU MDR and bear the CE mark for commercial distribution. The LARIAT System is a solution for soft-tissue closure that includes a suture loop coupled to a single-use disposable applier. The Lumitip dissector is used by surgeons to separate tissues to provide access to key anatomical structures that are targeted for ablation. Other enabling technologies include the company’s Glidepath guides for placement of its clamps, Subtle Cannula’s to support access for the company’s EPi-Sense catheters and a line of reusable cardiac surgery instruments.
Business Strategy
The company is passionately focused on healing the lives of patients affected by Afib and pain after surgery. The company’s strategy is to expand the treatment options for patients who suffer from Afib, have a high risk of stroke, may develop post-operative Afib, or who suffer from post-operative pain, through the continued development of its technologies and expansion of the company’s product offerings, clinical science investments and global commercial expansion.
The key elements of the company’s strategy are new product and procedure innovation; investments in clinical science; building physician and societal relationships; providing training and education; and evaluate acquisition opportunities.
Research and Product Development
The company’s ongoing research and development activities support its business strategy to expand treatment options and increase awareness in itsmarkets, as well as enabling expansion into adjacent markets. The company is engaged in developing and researching new and existing products or concepts, preclinical studies, clinical trials and other regulatory activities. The company makes significant investments in both product development and clinical science activities to drive the advancement and adoption of new therapies in the marketplace.
In the United States, a significant risk device requires the prior submission of an application for an Investigational Device Exemption (IDE) to FDA for approval before initiating a clinical trial. Clinical trials are required to support a pre-market approval (PMA) and are sometimes required for 510(k) clearance. Some trials require a feasibility study followed by a pivotal trial. The company is conducting several clinical trials to validate the long-term results of procedures using its products and to support applications to regulatory agencies for expanded indications. In addition, the company also conducts various studies to gather clinical data regarding its products. Key trials and studies are:
LeAAPS: In April 2022, FDA approved the protocol for the Left Atrial Appendage Exclusion for Prophylactic Stroke Reduction (LeAAPS) IDE clinical trial. The trial is designed to evaluate the effectiveness of prophylactic LAA exclusion using the AtriClip LAA Exclusion System for the prevention of ischemic stroke or systemic arterial embolism in cardiac surgery patients without pre-operative AF diagnosis who are at risk for these events. This prospective, multicenter, randomized trial evaluates safety at 30 days post-procedure to demonstrate no increased risk with LAA exclusion during cardiac surgery and effectiveness with a minimum follow-up of five years post procedure for all subjects. The trial provides for enrollment of up to 6,500 subjects at up to 250 sites worldwide. The company enrolled its first patient in January 2023; site initiation and enrollment is ongoing.
HEAL-IST: In February 2022, FDA approved the protocol for the Hybrid Epicardial and Endocardial Sinus Node Sparing Ablation Therapy for Inappropriate Sinus Tachycardia (IST) clinical trial (HEAL-IST). The HEAL-IST clinical trial is designed to study the safety and efficacy of a hybrid sinus node sparing ablation procedure using the Isolator Synergy Surgical Ablation System for the treatment of symptomatic, drug refractory or drug intolerant IST. The trial is a prospective, multicenter, single arm trial that evaluates safety 30 days post-procedure and evaluates primary effectiveness of freedom from IST (as specified) at 12 months post-procedure. The trial provides for enrollment of up to 142 patients at up to 40 sites in the United States, United Kingdom and European Union. The first patient enrollment in the trial occurred in June 2022; site initiation and enrollment is ongoing.
CONVERGE. The CONVERGE IDE clinical trial proved the safety and efficacy of the EPi-Sense System to treat symptomatic persistent and long-standing persistent Afib patients who are refractory or intolerant to at least one Class I and/or III anti-arrhythmic drug. In April 2021, FDA granted PMA approval of the EPi-Sense System for the treatment of symptomatic, drug-refractory, long-standing persistent atrial fibrillation, when augmented with an endocardial ablation catheter. The company’s Convergent procedure, or Hybrid AF therapy, provides the only compelling treatment option for a large and vastly underpenetrated population of long-standing persistent Afib patients. The CONVERGE trial demonstrated superiority in the hybrid therapy arm compared to endocardial catheter ablation alone. In April 2021, the company also received approval from FDA to conduct the CONVERGE Post Approval Study (PAS). This study allows for 325 patients to be enrolled at up to 50 sites. Site initiation and enrollment in the CONVERGE PAS is ongoing.
The company has and will continues to invest in other clinical trials to validate the long-term results of procedures using its products and to support applications to regulatory agencies for expanded indications. The company continues to perform long-term patient follow-up in multiple studies and plans to present results at 2025 meetings.
In May 2024, the company finished twelve-month patient follow-up required by the ICE-AFIB study protocol. The company has completed the analyses of the primary effectiveness and safety endpoints and is pursuing publication opportunities with reputable cardiac surgery journals. The ICE-AFIB clinical trial is designed to study the safety and efficacy of the cryoICE system for persistent and long-standing persistent Afib treatment during concomitant on-pump cardiac surgery.
The CEASE-AF three-year outcomes abstract was submitted and accepted for presentation at the 2025 European Heart Rhythm Association (EHRA) meeting. CEASE-AF is a prospective, multi-center randomized control trial that demonstrated superior freedom from atrial arrhythmias for staged hybrid ablation compared to endocardial catheter ablation.
During the fourth quarter of 2023, the 12-month follow-up results of enrolled patients from the DEEP AF Pivotal study were presented at the American Heart Association meeting. The two-year DEEP outcomes poster has been accepted for presentation at the 2025 AF Symposium. The DEEP AF IDE pivotal trial evaluated the safety and efficacy of the AtriCure Bipolar System when used in a staged approach where a minimally invasive surgical ablation procedure is first performed. The patient undergoes the endocardial catheter procedure approximately 91-120 days later. The results from this single arm study demonstrated superior freedom from atrial arrhythmias for staged hybrid ablation compared to a pre-specified performance goal.
The company is conducting analyses of additional trial data for publication, future development activities, or possible evaluation of label expansions.
Sales, Marketing and Medical Education
The company’s global sales and marketing efforts focus on educating physicians about its unique technologies and their clinical benefits. The company only promotes its products for uses described in their labeling as cleared or approved by relevant regulatory agencies and train its sales force on the use of its products to the extent the products are cleared or approved.
The company’s sales team in the United States has approximately 310 employees. The company selects its sales personnel based on their expertise, experience and reputation in the medical device industry and their knowledge of cardiac and thoracic surgery procedures and technologies.
The company markets and sells its products in selected countries outside of the United States through a combination of independent distributors and direct sales personnel. The company’s international sales team includes approximately 70 employees focused on its direct markets, such as Germany, France, the United Kingdom, the Benelux region, Canada, and Australia. The company also maintains a network of distributors who market and sell its products in Asia and South America, as well as certain countries in Europe. The company continues to evaluate opportunities for further expansion into markets outside of the United States.
Competition
The company’s primary competitor in the cardiac surgery market is Medtronic, plc.
Government Regulation
The company’s products are medical devices and are subject to regulation in the United States by FDA and other federal agencies, and by comparable authorities in the European Union (EU) and other countries worldwide.
FDA regulations govern nearly all of the activities that the company performs, or which are performed on its behalf, to ensure that medical products distributed domestically or exported internationally are safe and effective for their intended uses.
To obtain 510(k) clearance, the company must submit a notification to FDA demonstrating that its proposed device is substantially equivalent to a predicate device, i.e., a previously cleared and legally marketed 510(k) device or a device that was in commercial distribution before May 28, 1976, for which FDA has not yet called for the submission of a PMA.
AtriCure is a member of the Advanced Medical Technology Association (AdvaMed), a voluntary United States trade association for medical device manufacturers. This association has established guidelines and protocols for medical device manufacturers in their relationships with healthcare professionals on matters including research and development, product training and education, grants and charitable contributions, support of third-party educational conferences and consulting arrangements.
The company’s clinical trials must be conducted under the oversight of an Institutional Review Board (IRB) for the relevant clinical trial sites and must comply with FDA regulations, including, but not limited to, those relating to current good clinical practices. The company is also required to obtain the written informed consent of patients in form and substance that complies with both FDA requirements and other human subject protection regulations established by FDA. The company must conduct its clinical studies in compliance with state and federal privacy laws, including the Health Insurance Portability and Accountability Act (HIPAA). The company’s manufacturing facilities and processes are also subject to FDA inspections to ensure compliance with Quality System Regulations (QSR).
The company has adopted the AdvaMed Code by incorporating its fundamental principles into its Global Health Care Compliance Manual and incorporated its principles in its compliance policies, employee training programs and relationships with medical professionals.
The company has adopted the MedTech Code and incorporated its principles into its Global Health Care Compliance Manual, employee training programs and relationships with medical professionals. This manual also takes into account other global compliance principles as set forth in other international codes of ethics, such as the APAC Med Code of Ethical Conduct and AdvaMed China Code.
AtriCure is a member of MedTech Europe, a voluntary trade association for the medical technology industry, including diagnostics, medical devices and digital health. MedTech Europe and its members are committed to a high level of ethical business practices and have put in place strict guidelines to advise medical technology manufacturers on how to collaborate ethically with healthcare professionals (HCPs). These guidelines are set out in the MedTech Europe Code of Ethical Business Practice (MedTech Code), which regulates all aspects of the industry's relationships with HCPs and healthcare organizations (HCOs).
The company’s physician consulting agreements are intended to satisfy the requirements of the personal services ‘Safe Harbor’ regulation, as well as the AdvaMed Code and the MedTech Europe Code of Ethical Business Practice.
Consulting Relationships
The company has developed consulting relationships with scientists and physicians throughout the world to support its research and development, clinical and training and education programs. The company works closely with these thought leaders to understand unmet needs and emerging applications for the treatment of Afib and other diseases and conditions.
Trademarks
The company owns or has the rights to use various trademarks, including Isolator Synergy clamp, EPi-Sense coagulation device, EnCompass clamp, AtriClip Flex·V device, and cryoSPHERE probes, among others, and their respective logos.
Manufacturing
The company regularly audits its suppliers for compliance with its quality system requirements, the QSR and/or applicable International Organization of Standardization (ISO) standards. The company is an FDA-registered medical device manufacturer and certified to ISO 13485:2016. The company routinely conducts internal audits of its quality systems in accordance with various international standards. In addition, the company has successfully participated in the Medical Device Single Audit Program (MDSAP) and have been certified accordingly. The MDSAP program is recognized in Australia, Brazil, Canada, Japan, and the United States.
History
AtriCure, Inc. was founded in 2000. The company was incorporated in the state of Delaware in 2000.
