EP News

TYRX^® Receives New Product Innovation Award

TYRX, Inc., the leader in the commercialization of implantable medical devices designed to help reduce surgical-site infections associated with cardiovascular implantable electronic devices (CIEDs) including pacemakers and implantable defibrillators, announced that Frost & Sullivan has named the AIGISRx^® Antibacterial Envelope as the recipient of its prestigious New Product Innovation Award for 2012.

“To date, TYRX’s AIGISRx is very unique in the fact that it is the first and only antibacterial product of its kind to receive U.S. Food and Drug Administration (FDA) clearance. The product not only helps in stabilizing the pacemaker or ICD, but it also helps reduce infection by delivering antibiotics directly to the surgical site in the first 7 to 10 days following implantation,” said Darshana De, IP and Best Practices Analyst from Frost & Sullivan.

The AIGISRx Antibacterial Envelope is designed to address surgical-site infections, which are expensive to treat and have a significant impact on patients and hospitals.

Patients suffering from surgical-site infections following CIED procedures:

• spend an average of two extra weeks in the hospital
• undergo repeat surgical procedures to treat the infection
• cost the facility an average of $72,485
• experience significant increases in morbidity and mortality, with one-year mortality rates of 26.5% to 35.1%, depending on device type.

The recipient of the Frost & Sullivan New Product Innovation Award is selected after rigorous analysis of industry’s leading companies who demonstrate outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development.

“Since TYRX was founded, we have been working diligently to research, develop, and commercialize technologies which help reduce surgical-site infections and improve patient outcomes,” remarked Robert White, President and CEO of TYRX. “Our team appreciates Frost & Sullivan’s acknowledgement of our product leadership and innovation.”

About TYRX, Inc.
TYRX, Inc., headquartered in Monmouth Junction, New Jersey, is a pioneer in the development, manufacture, and distribution of innovative, implantable combination drug-device products including the AIGISRx^® Antibacterial Envelope. The AIGISRx Envelope is specifically designed to aid in the stabilization of CIED placement as well as to help reduce surgical-site infections associated with cardiac implantable electronic devices (CIEDs). AIGISRx products contain the antimicrobial agents rifampin and minocycline, which have been shown to reduce infection by organisms representing the majority of the infections reported in CIED-related endocarditis, including “superbugs” or MRSA.^*

For more information, please visit www.TYRX.com or www.HeartDeviceInfection.com.

^* Data on file at TYRX and published in Pacing Clin Electrophysiol 2009;32(7):898-907.

AtriCure Launches Three-Year Post-Approval Study for the Surgical Correction
of Atrial Fibrillation

AtriCure, Inc., the leader in surgical ablation for the treatment of atrial fibrillation (AF), has announced FDA approval of the ABLATE Post Approval Study (PAS). This landmark three-year, 350-patient study is a follow-up to the company’s December 14, 2011 FDA approval of the AtriCure Synergy Ablation System for the surgical treatment of AF. AtriCure is the first and only surgical company with a specific, on-label indication for AF. The PAS study is intended to build additional evidence on the safety, efficacy and long-term durability of the Maze IV concomitant treatment for AF using AtriCure’s proprietary surgical devices.

The initial FDA approval study, ABLATE, reported 84 percent of patients free from AF at six months following Maze IV treatment and 75 percent of patients free of AF at a mean follow-up of 22 months when assessed by 48-hour Holter monitors. The Maze IV procedure is normally performed at the time of a primary open-heart procedure where access to the heart is routinely established.

The ABLATE and PAS studies focus on the most difficult to treat, chronic forms of AF known clinically as “non-paroxysmal AF.” The chronic AF patient group represents roughly half of the diagnosed patient population and has been extremely challenging to manage with conventional medical therapy or catheter ablation.

According to Patrick McCarthy, MD,^* Director of the Bluhm Cardiovascular Institute at Northwestern University Feinberg School of Medicine and Chair of the PAS Executive Committee, “The ABLATE Post Approval Study represents an important study which will provide the evidence to validate the treatment of these underserved patients with intractable forms of AF,” he says. “This trial represents the most comprehensive experience for any treatment option for atrial fibrillation, and we’re looking forward to this significant study designed to treat patients with this life-threatening condition.”

The company’s founder, Michael Hooven, is optimistic about the FDA approval and the PAS. “Receiving the first and only FDA approval for the surgical treatment of atrial fibrillation was a major milestone for AtriCure. We are now able to fulfill our mission of improving patient outcomes by offering a standardized surgeon training program focused on the Maze IV procedure. Our data suggests that currently only 3 in 10 cardiac surgery patients with an AF diagnosis receive an AF procedure and only 1 in 10 receive a complete Maze IV procedure. We expect the PAS study will provide additional compelling evidence of the benefits of the AtriCure Maze IV procedure and be a catalyst for making it the standard of care.”

Concurrently with the post-approval study, AtriCure is sponsoring an extensive Maze IV training program for cardiovascular surgeons. This course was developed by recognized leaders in the field of surgical ablation and is recognized by the Society of Thoracic Surgeons as an Endorsed Industry Education Program. For more information about this course, visit targetaf.com.

About AtriCure, Inc.
AtriCure, Inc. is a leader in medical device development, manufacturing and sales of innovative cardiac surgical ablation systems designed for the treatment of AF and for the exclusion of the left atrial appendage. AF affects more than two million people in the United States and is responsible for 15 percent of strokes. It is estimated that by 2050 more than 12 million individuals will have a form of AF. For more information regarding AtriCure, visit www.atricure.com.

The FDA has not cleared or approved certain AtriCure products for the treatment of AF or a reduction in the risk of stroke.

^* Dr. McCarthy has been reimbursed by AtriCure for limited travel and related expenses related to his involvement in the ABLATE AF PAS clinical trial.

Sorin Group Receives SFDA Approval and Announces Commercial Launch of REPLY^™ and ESPRIT^™ Families of Pacemakers in China

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced the marketing approval from China’s State Food and Drug Administration (SFDA) and full commercial launch in China of the REPLY and ESPRIT families of pacemakers. Both families include easy-to-use functions and patient safety features, with REPLY, at 8ccs, maintaining its position as the world’s smallest dual-chamber pacemaker.

The REPLY and ESPRIT families have several common attributes: some of the industry’s smallest devices, uncompromised longevity, and SMARTCHECK^™, a tool designed to simplify device checks by automating follow-up tests at the click of a button. In addition, each device presents its own unique features:

• The REPLY pacemakers, the smallest dual-chamber pacemakers on the market, offer the exclusive pacing mode, SafeR^™, which constantly monitors and promotes the patient’s natural cardiac activity. SafeR is the world’s first pacing mode to maintain over 99% intrinsic conduction.¹ Delivering unnecessary pacing to the right ventricle has been shown to significantly increase the risk of heart failure and atrial fibrillation, two conditions that can prove fatal and place a heavy cost burden on healthcare systems. Recently published results have shown that SafeR nearly eliminates unnecessary ventricular pacing¹  and adds two-year² device longevity.
• The ESPRIT pacemakers include numerous algorithms designed for patient safety: continuous lead impedance measurements to monitor the lead integrity, automatic adjustment of atrial and ventricular sensing, and ventricular autothreshold to automatically adjust pacing output in case of changing thresholds, thereby enhancing the device performance and longevity.

“I have worked closely with Sorin Group for the last 15 years. Sorin is strongly committed to better patient outcomes,” said Professor Frédéric Anselme, MD, PhD, Rouen University Hospital, France. “Sorin’s new small and long-lasting REPLY and ESPRIT devices have brought tremendous benefits to thousands of European patients. These clinical benefits will now be made available to patients in China who will also be given chances to rely on their heart’s natural conduction when it’s intact,” he added.

“Sorin Group is the market leader in the cardiac surgery segment in China. Sorin Group has a long tradition of delivering innovative therapies for the management of cardiac arrhythmia and heart failure patients over the last 40 years,” Jerry Wang, General Manager, Sorin Group China. “We are very proud to be able to bring the world’s smallest pacemaker family to patients and physicians in China.”

About Sorin Group
Sorin Group (www.sorin.com) is a global medical device company and a leader in the treatment of cardiovascular diseases. The company develops, manufactures, and markets medical technologies for cardiac surgery and for the treatment of cardiac rhythm disorders. With 3,750 employees worldwide, Sorin Group focuses on three major therapeutic areas that include: cardiopulmonary bypass (extracorporeal circulation and autotransfusion systems), cardiac rhythm management, and heart valve repair and replacement. Every year, over one million patients are treated with Sorin Group devices in more than 80 countries.

¹Davy JM, Hoffmann E, Frey A, et al. Near elimination of ventricular pacing in SafeR mode compared to DDD modes: A randomized study of 422 patients. Pacing Clin Electrophysiol 2012;35(4):392–402.
²Benkemoun H, Sacrez J, Lagrange P, et al. Optimizing pacemaker longevity with pacing mode and settings programming: Results from a pacemaker multicenter registry. Pacing Clin Electrophysiol 2012;35(4):403–8.

New CardioFocus HeartLight^® Data Reinforces Impressive Single Procedure Chronic Success Rates in the Treatment of Atrial Fibrillation

CardioFocus, Inc., developer of the HeartLight^® Endoscopic Ablation System (EAS) for the treatment of atrial fibrillation (AF), announced new data showing pulmonary vein isolation (PVI) with its technology leads to a 99% acute success rate and up to an 82% chronic success rate at 12-month follow-up. In addition, the research indicates the HeartLight laser balloon technology resulted in improved long-term outcomes after a single procedure as compared with the cryothermal balloon catheter. The data was presented on August 26 at the European Society of Cardiology (ESC) Congress 2012, in Munich, Germany.

Stephen Sagon, President and CEO of CardioFocus, said, “The presented outcomes data with the HeartLight system are particularly impressive because high chronic success rates have been elusive, let alone from a single procedure. We are encouraged by the continued performance of our system and its positive impact on patient care, especially as compared with alternative ablation technologies. As physicians hone their technique with endoscopically-guided ablation, we anticipate further studies reinforcing these durable success rates.”

In the presented study titled, “Laser or Cryo? Prospective comparison of balloon based PVI technologies,” researchers from Cardioangiologisches Centrum Bethanien (CCB), Frankfurt, Germany allocated 140 patients 1:1 to undergo catheter ablation with the HeartLight laser balloon or the cryothermal balloon (Medtronic Arctic Front^®). Acute isolation rates were comparable (98.9% vs. 99.6%, respectively). However, during 12-month follow-up, 37% of patients treated with the cryoballoon experienced AF recurrence vs. only 27% treated with a single HeartLight system procedure. 

After repeat procedures with radiofrequency ablation as needed, both technologies demonstrated a chronic success rate of approximately 80%, though notably, the number of redo procedures was twice as high with the cryothermal balloon vs. HeartLight (22 vs. 11). Analysis of the veins themselves also demonstrated a 37% relative risk reduction of PV reconnection using the HeartLight technique.

“We were interested in prospectively evaluating the outcomes achievable with HeartLight compared to the established cryothermal balloon catheter,” said Boris Schmidt, MD, of CCB. “While we found the systems to have comparable safety and acute efficacy outcomes, the HeartLight system, in fact, led to a higher rate of longer-term freedom from AF after a single procedure. We look forward to further, multicenter study on this comparison.”

In the second presentation, titled “Pulmonary vein isolation for paroxysmal atrial fibrillation with the laser balloon,” researchers at Na Homolce Hospital in Prague, Czech Republic, highlighted outcomes of three years (2009-2011) of HeartLight cases at their center. They found that at a mean 12-month follow-up, 82% of patients remained free from AF. In addition, acute PVI was documented at 100% for all of 2011, supporting the short learning curve and high reproducibility of the procedure.

“These data are a testament to our positive experiences with the HeartLight Endoscopic Ablation System since its incorporation into our practice over three years ago,” said Prof. Petr Neuzil, MD, of Na Homolce Hospital. “Our research demonstrates the laser balloon PV isolation procedure to be safe, with acute results comparable to those of radiofrequency ablation procedures and longer-term results showing a compelling degree of continued isolation.”

In addition, these recently available clinical results were the focus of an academic symposium on the evening of August 27. Cardiologists from across Europe and the U.S. discussed their experiences with the system for PVI and its potential to improve the safety and efficacy in AF ablation.

About CardioFocus, Inc.
CardioFocus, Inc. is a medical device manufacturer dedicated to advancing ablation treatment for cardiac disorders such as AF. Its novel HeartLight^® Endoscopic Ablation System for catheter ablation incorporates an endoscope to provide physicians with the capacity to see within the heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation.

The HeartLight Endoscopic Ablation System is commercially available at leading institutions throughout Europe and in Australia. The device is investigational in the U.S., and currently the focus of a pivotal trial initiated in 2012. CardioFocus is headquartered in Marlborough, MA. For more information on the company and its technology, please visit www.CardioFocus.com.

The scientific information discussed in this news release is preliminary and investigative. The CardioFocus HeartLight Endoscopic Ablation System is not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the system. Only the FDA can determine whether the product candidates are safe and effective for the use(s) being investigated. Healthcare professionals should refer to/rely upon FDA-approved labeling for the products, and not the information discussed in this news release.

Estech Launches Next Generation Technology, the COBRA Fusion^™ System for Cardiac Ablation

Estech, a leading provider of minimally invasive cardiac ablation devices, announced the market release of its COBRA Fusion^™ ablation system. This revolutionary technology is the first of its kind to use a unique suction application and innovative electrode configuration to gently pull the tissue targeted for ablation into the device and out of the path of circulating blood. The COBRA Fusion^™ ablation system overcomes the most significant challenge faced in minimally invasive epicardial ablation, the cooling effect of the circulating blood inside the heart, and reproducibly creates transmural (full-thickness) lesions on a beating heart. This bipolar clamping technology in the form of an epicardial catheter is thus capable of creating linear lesions anywhere on a beating heart with unprecedented performance and ease of use.

The COBRA Fusion ablation system incorporates proprietary Versapolar^™ technology — an exclusive innovation that delivers both bipolar and monopolar radiofrequency (RF) energy to the targeted cardiac tissue, enabling transmural lesion formation in thin and thick cardiac tissue. As with all COBRA^® ablation systems, the new device is powered by Estech’s patented temperature controlled radiofrequency (TCRF) energy which continuously monitors and maintains tissue temperature at target levels throughout the procedure. TCRF avoids the need for multiple applications that other technologies often require and ensures that tissue temperatures remain within a safe and effective range.

James L. Cox, MD, the pioneer and creator of the Cox-Maze procedure, stated, “I have had the recent opportunity to observe the clinical use of this new device in several patients. The historical problem of attaining atrial wall transmurality reliably in a beating, working heart by applying ablative energy from the epicardium only, appears to have been solved with this new device.” Dr. Cox added, “The ability to involute the atrial wall into the ablation device itself using suction allows for the application of radiofrequency energy to both sides of the involuted tissue, thereby creating reproducible transmural and contiguous linear lesions for the first time off-pump. Moreover, the device is small enough to fit through a standard port, using an endoscopic port-access approach. I believe that this device represents a significant addition to the surgeon’s armamentarium in the field of cardiac ablation.” Dr. Cox is the Evarts A. Graham Professor of Surgery Emeritus, Chief, Division of Cardiothoracic Surgery Emeritus, Washington University School of Medicine, Barnes-Jewish Hospital, St. Louis, MO.

The COBRA Fusion is the result of several years of research and development and has been extensively tested in several labs including the prestigious research lab at Washington University in St. Louis. Ralph J. Damiano, MD, stated, “We have evaluated this new device in our animal lab and were very impressed with the results. It is an innovative device that has the potential to facilitate minimally invasive surgical ablation. It is likely to advance the field by improving lesion formation on the beating heart.”

Dr. Damiano is the John M. Shoenberg Professor of Surgery, Chief of Cardiac Surgery, Washington University School of Medicine, in St. Louis.

The COBRA Fusion^™ ablation system received FDA clearance in April, CE mark in May and has been in extensive clinical evaluations in the U.S. and E.U. since then. One of the health care institutions that have used this new technology in a clinical setting is the UNC Center for Heart and Vascular Care, Chapel Hill, NC, where professor and cardiothoracic surgeon Andy C. Kiser, MD, and professor and electrophysiologist J. Paul Mounsey, B.M. B.Ch., have performed numerous hybrid ablation procedures. Dr. Mounsey stated, “The electrical isolation we have obtained with the COBRA Fusion system is superior to any other epicardial ablation technology we have used. The ablation lines have been consistent and complete in the immediate postoperative period and long lasting as judged by follow-up a few weeks later.”

About Estech
Estech develops and markets a portfolio of innovative medical devices that enable cardiac surgeons to perform a variety of surgical procedures, while specializing in minimally invasive and hybrid ablation. The company’s COBRA line comprises a number of first-ever ablation technologies invented, developed, and brought exclusively to market by Estech. These include temperature-controlled RF energy delivery, Versapolar^™ devices that provide both bipolar and monopolar energy, suction-applied tissue contact, and internally-cooled devices which provide superior ablation performance compared to other ablation systems. For more information, please visit www.estech.com.

COBRA Fusion Ablation System: Regulatory Disclaimer
In the U.S. the Estech Cobra Fusion is intended to ablate cardiac tissue during cardiac surgery using radiofrequency (RF) energy when connected directly to the Estech Electrosurgical unit (ESU).

The Estech Cobra Fusion may be used for temporary cardiac pacing, sensing, recording, and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.

The Estech ablation products are not approved for the treatment of atrial fibrillation in the U.S. Estech has received Investigational Device Exemption (IDE) approval from FDA to begin enrollment in a clinical trial to support a PMA submission to obtain a specific atrial fibrillation indication in the U.S. for several products. In Europe, the Estech COBRA ablation products are CE marked with an indication for the treatment of atrial fibrillation.

The Joint Commission and the American Heart Association/American Stroke Association Launch New Certification Program for Comprehensive Stroke Centers

The Joint Commission and the American Heart Association/American Stroke Association announced the September 1, 2012 launch of their new Disease-Specific Care Advanced Certification Program for Comprehensive Stroke Centers.

The goal of this new level of certification is to recognize the significant differences in resources, staff and training that are necessary for the treatment of complex stroke cases. The Joint Commission and the American Heart Association/American Stroke Association anticipate that, over time, municipalities and regions will develop a formal referral network so the most complicated stroke cases can be treated at the centers best equipped to provide the specialized care that can lead to the best possible outcomes for stroke patients. It is anticipated that there may be more than 200 certified comprehensive stroke centers in the U.S. over the next few years.

“Stroke can be devastating, but the proper treatment program can make a tremendous difference for patients. The Joint Commission and the American Heart Association/American Stoke Association’s advanced certification program will help health care organizations focus on the care processes that produce the best outcomes for complex stroke cases and give Americans who suffer a stroke confidence that these health care organizations are committed to quality care,” says Jean Range, MS, RN, CPHQ, executive director of Disease-Specific Care Certification, The Joint Commission.

“The American Heart Association/American Stroke Association is pleased to be a part of the Advanced Certification Program for Comprehensive Stroke Centers. Primary Stroke Centers have greatly improved the care and outcomes for stroke patients and we anticipate that the growth, certification and proliferation of Comprehensive Stroke Centers will build on that success to have a similar effect for those patients with the most severe and challenging types of strokes.” says Mark Alberts, MD, FAHA, American Heart Association/American Stroke Association spokesperson and Professor of Neurology and Chief of the Division of Stroke and Cerebrovascular Disease at Northwestern University Feinberg School of Medicine.

Advanced Certification for Comprehensive Stroke Centers builds on the Advanced Certification for Primary Stroke Centers that is based on the Brain Attack Coalition’s “Recommendations for the Establishment of Primary Stroke Centers” (JAMA, June 21, 2000, Vol. 283, No. 23). There are currently more than 900 certified Primary Stroke Centers that have an established, formal program to treat stroke patients effectively and consistently with the goal of improving care and outcomes.

For more information about the Advanced Certification for Comprehensive Stroke Centers program, please call 630.792.5291 or e-mail dscinfo@jointcommission.org.