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Sorin Group Receives CE Mark Approval for PARADYM™ RF ICDs and CRT-Ds

Sorin Group announced the CE mark approval for the PARADYM™ RF¹ family of implantable cardiac defibrillators and cardiac resynchronization therapy devices.

Sorin Group, a global medical device company and a leader in the treatment of cardiovascular diseases, announced the CE mark approval for the PARADYM™ RF¹ family of implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy devices (CRT-D). With their proprietary algorithms, SafeR™ and Parad+™, PARADYM™ RF remote monitoring-enabled ICDs and CRT-D automatically adjust to provide individualized, appropriate therapy in a thin, powerful, long-lasting device.

The PARADYM™ RF devices are designed to be monitored remotely with Sorin’s new, easy-to-use SMARTVIEW™ remote monitoring system. The SMARTVIEW™ system provides daily monitoring and scheduled remote follow-up of patients’ device status, providing convenience and peace of mind to physicians and patients.

PARADYM RF™ CRT-D and ICDs are designed to provide patients with the optimal combination of thinness, high power and longevity. Utilizing state-of-the-art battery and capacitor technology and an innovative remote monitoring design featuring high speed data transfer and monitor-initiated connection, the PARADYM™ RF CRT-D and ICD devices deliver 37J of energy with longevity over 6 years² and 9 years,³ respectively, in an 11mm thin device.

The PARADYM™ RF family includes Sorin’s proprietary SafeR™ and Parad™+ algorithms that automatically adjust to each individual patient to minimize right ventricular pacing and inappropriate shocks.

“Too many ICD patients receive inappropriate shocks and unnecessary RV pacing, resulting in decreased quality of life and increased mortality risk for patients. PARADYM™ devices are the only clinically proven ICDs that both reduce RV pacing below 1%^4,5 and offer the lowest recorded inappropriate shock rate⁶ on the market to date,” said Professor Brachmann from the Department of Cardiology at Klinikum Coburg (Germany), the first institution to implant the PARADYM™ RF CRT-D.

The PARADYM™ RF CRT-D also features a new programming option to electronically reprogram the device to avoid phrenic nerve stimulation, a common side effect of resynchronization therapy. In addition, PARADYM™ RF CRT-Ds include Sorin’s exclusive Brady-Tachy Overlap (BTO™) algorithm that provides pacing therapy during exercise while maintaining the ability to detect and treat slow ventricular arrhythmias. “We are impressed with the abilities of the new device,” said Professor Brachmann. “With BTO™ programming, we are able to encourage our heart failure patients to follow their cardiac rehabilitation program after CRT-D implant.”

Stefano Di Lullo, Sorin Group, President of the CRM Business Unit, commented, “Sorin Group is delighted to have obtained CE mark approval for the full PARADYM™ RF family. The introduction of these new remote monitoring enabled devices brings a wide range of treatment options for physicians, but it is also consistent with our objective to provide best therapies and patient management solutions to patients and medical professionals.”

References

1. Investigational use only. Not available for distribution.
2. Biventricular pacing in DDD mode, 1% in atrium, 100% in both ventricles, 500 Ohm, 3.5 V, 0.35 ms, 60 min-1, one 42 J shock per quarter, sensors OFF, remote monitoring: daily check, 4 remote follow-ups and 5 alerts with full reports per year.
3. Pacing in VVI mode 1%, 500 Ohm, 3.5 V, 0.35 ms, 60 min-1, one 42 J shock per quarter, sensors OFF, remote monitoring: daily check, 4 remote follow-ups and 5 full alert reports per year.
4. “AAIsafeR preserves ventricular activity in case of Paroxysmal AV Block while maintaining ventricular pacing below 0.1% in 28/35 (80%) of non-selected DDD patients” p. S246, Anselme F, et al. First clinical results of AAIsafeR2, a new mode to prevent ventricular pacing. Heart Rhythm 2005; 2, supp 5; p4-99 (abs).
5. With SafeR mode.
6. Anselme F, et al. Prevention of Inappropriate shocks in ICD Recipients: A review of 10000 Tachycardia Episodes. PACE, Vol 30, January 2007, Supplement 1. Study made using dual-chamber ICDs with standard dual-chamber arrhythmia classification algorithms. 

Medtronic Receives Health Canada Approval for First and Only Cryoballoon Ablation Treatment in Canada for Paroxysmal Atrial Fibrillation

Medtronic of Canada Ltd. announced that Health Canada has approved its Arctic Front^® Cardiac CryoAblation Catheter System, the first and only Cryoballoon in Canada indicated for the treatment of patients suffering from paroxysmal atrial fibrillation. The Cryoballoon treatment involves a minimally-invasive procedure that efficiently creates circumferential lesions around the pulmonary vein, which is the source of erratic electrical signals that cause the irregular heartbeat.

Cryoballoon-based technology is novel because it ablates or blocks the conduction of atrial fibrillation (AF) in cardiac tissue through the use of a coolant delivered through a catheter, rather than heat. This freezing technology allows the catheter to adhere to the tissue during ablation, allowing for greater catheter stability.

“Cryoballoon technology is a major improvement over the traditional focal approach for the treatment of atrial fibrillation,” said Dr. Marc Dubuc, Cardiologist and Electrophysiologist at the Montreal Heart Institute and Associate Professor at the Faculty of Medicine, University of Montreal. “The delivery of circumferential lesions around the pulmonary veins reduces the duration of the procedure while being effective and safe.”

The Health Canada approval of the Arctic Front System was based on the pivotal STOP AF (Sustained Treatment of Paroxysmal Atrial Fibrillation) trial, which demonstrated the safety and efficacy of the device in treating and eradicating paroxysmal atrial fibrillation. The study showed that 69.9 percent of patients treated with the Arctic Front System were free from atrial fibrillation at one year, compared to 7.3 percent of patients treated with drug therapy only. The study also demonstrated that treatment with the device is safe, when used as indicated, with limited procedure-related adverse events (3.1 percent), and patients enrolled in the study displayed a significant reduction of symptoms, a decrease in the use of drug therapy and substantial improvements in both physical and mental quality-of-life factors.

“We are pleased with the success we obtained using cryoablation in the North American STOP AF trial, and our patients have done extremely well,” said Dr. Peter Guerra, Cardiologist and Chief of Electrophysiology Service at the Montreal Heart Institute and Assistant Professor in the Faculty of Medicine at the University of Montreal. “Now, at last, we can offer this technology to all our patients. Since cryoablation for cardiac ablation was pioneered at the Montreal Heart Institute, we are anxious to move forward with this new tool.”

Dr. Jean Champagne, Cardiologist and Electrophysiologist at The Institut Universitaire de Cardiologie et Pneumologie de Québec added, “It has been four years since I treated my first patient with the Arctic Front balloon as part of the STOP AF trial, and in my experience it allows for deeper lesions, has a higher healing rate than our current ablation technique and leads to very few long-term atrial fibrillation recurrences. We are pleased that this technology has finally been accepted in Canada and is now available to our patients.”

Medtronic acquired Montreal-based CryoCath Technologies, Inc. and U.S.-based Ablation Frontiers, Inc., to form Medtronic’s AF Solutions division within the Cardiac Rhythm Disease Management business. When combined with Medtronic's existing EP Systems product portfolio, AF Solutions offers an extensive line of diagnostic, cryoablation (freezing technology) and radiofrequency ablation tools to diagnose and treat a broad spectrum of cardiac arrhythmias.

“This system was designed, developed and manufactured in Canada with a global mandate, including supplying the US and Europe,” said Neil Fraser, President of Medtronic of Canada. “We are very excited this novel technology, which has already been used to treat more than 15,000 patients in more than 200 centers outside of Canada, is now also approved in this country.”

Cameron Health Completes Enrollment in Pivotal FDA Clinical Study of the S-ICD^® System

Cameron Health, Inc. announced that it has completed enrollment in its pivotal FDA clinical study of the S-ICD System, the world’s only completely subcutaneous implantable defibrillator.

The S-ICD System pivotal study is a prospective multicenter, single-arm study design approved by the FDA under an investigational device exemption (IDE). Clinical investigators enrolled 330 patients at risk for sudden cardiac arrest (SCA) at 33 centers in the United States, Europe and New Zealand. The pivotal study has primary clinical endpoints of arrhythmia conversion efficacy and complication-free rate at six months for qualified patients. The top five enrolling centers in the S-ICD System pivotal study were The Ohio State University, University of Chicago, Emory University, Sentara Heart Hospital and Auckland City Hospital.

“Completing enrollment in the S-ICD System pivotal study is another key milestone for the S-ICD System, and for Cameron Health. The data from this pivotal study will support our US approval process, which will ultimately significantly expand access to this important new technology for patients at risk of SCA,” said Kevin Hykes, President and CEO, Cameron Health.

Cameron Health plans to submit data from this pivotal study to the FDA in late 2011 requesting marketing approval for the S-ICD System in the United States. The S-ICD System received CE mark in Europe in 2009 based on data recently published in the July 2010 issue of the New England Journal of Medicine. Approximately 800 patients have been implanted with the S-ICD System worldwide.

“The S-ICD System is an important new technology that will be a viable treatment option for patients at risk for SCA,” said Dr. Raul Weiss, Associate Professor-Clinical, Cardiovascular Medicine at The Ohio State University. “The S-ICD System represents the first meaningful advance in ICD technology in many years.”

The S-ICD System is unique in that the implantation of the system is entirely subcutaneous, eliminating the need for electrical wires (leads) to be placed in the heart. The S-ICD System detects highly accelerated and disorganized heart rhythms and provides a jolt of electricity (or shock) to restore the heart’s normal rhythm and prevent SCA. Left unaddressed, these disorganized heart rhythms are often fatal.

“We are encouraged by our experience with the S-ICD System in this pivotal study and look forward to reporting the results. Having the option to implant an ICD that does not require placement of leads directly in the heart would be an important new alternative for countless patients. The S-ICD System represents a true breakthrough backed by years of research,” said Dr. Martin Burke, Director of the Heart Rhythm Center at the University of Chicago.

Endosense and Siemens Healthcare Unveil Prototype Software Visualizing Contact-Force Data in 3D Anatomic Heart Model

Endosense, a Swiss medical technology company, and Siemens Healthcare, one of the world’s largest suppliers to the healthcare industry, have announced completion of prototype software integrating the contact-force data provided by Endosense’s TactiCath^® force-sensing ablation catheter¹ with Siemens’ electrophysiology solutions. The new application, which was created under a joint development agreement announced in January 2011, was designed to allow electrophysiologists to view catheter tip-to-tissue contact force within a fluoroscopically-enabled, three-dimensional anatomic heart model during catheter ablation procedures.

“The ability to visualize contact force in real time represents a significant step forward in the catheter ablation treatment of cardiac arrhythmias,” said Dipen Shah, MD, University Hospital of Geneva, who will soon demonstrate the technology’s feasibility by performing the first patient case. “Using this new software, we gain the ability to not only measure and control contact force in real time but also view it within the three-dimensional context of the heart anatomy. I believe the enhanced visualization will allow me and my fellow electrophysiologists to perform catheter ablation with an even greater level of insight and confidence, ultimately translating into procedures that are more effective and safe.”

Eric Le Royer, chief executive officer, Endosense, also commented on the development milestone. “With the completion of this all-in-one software prototype, we have proven our ability to deliver the critical dimension of contact-force sensing on a totally new platform. The speed and quality of execution of our collaboration has been remarkable since we announced it in January of this year. We look forward to bringing this new technology to market to both expand the use and enhance the benefits of force control in the EP lab.”

Commenting on the development milestone, Martin Ostermeier, Director Innovations of the Interventional X-ray business unit of Siemens Healthcare, added, “We believe catheter tip force sensing will play a major role in the EP lab in order to improve safety and success rate of cardiac ablation procedures. The completed prototype will allow us to evaluate the clinical benefits of Endosense’s TactiCath technology integrated into future Siemens Healthcare products.”

References

1. Caution: In the United States, the TactiCath is an investigational device. Limited by Federal (or United States) law to investigational use.

Biosense Webster Announces Agreement to Distribute Stereotaxis Odyssey™ Product Portfolio Worldwide

Biosense Webster, Inc., the worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the extension of their strategic collaboration with Stereotaxis, Inc.

Under the terms of the agreement, Biosense Webster gains non-exclusive worldwide distribution rights to Stereotaxis’ rapidly growing Odyssey™ portfolio of products and will sell these products in EP labs around the world and leverage the market-leading installed base of its Carto^® 3 3D Mapping System. The combined solutions from both companies will drive improved workflow and optimize the remote technical and clinical support of electrophysiology practices globally.

“This extension of our current strategic collaboration will undoubtedly enhance our current world-class clinical support that we provide every day to the thousands of electrophysiologists around the world through Odyssey™ Cinema, in addition to providing them with a consolidated view of patient information in a single display through Odyssey™ Vision,” said Shlomi Nachman, Biosense Webster’s Worldwide President.

The Odyssey™ portfolio allows the operation of the entire lab as one system, thus streamlining procedure workflow and the enabling of virtual remote support of cardiac ablation procedures and professional training, which is both personalized to the electrophysiologists performing the procedure and also scalable on a global basis.

Biosense Webster and Stereotaxis have a longstanding co-development agreement, where Biosense Webster designs and distributes magnetically enabled catheters for use with Stereotaxis’ Niobe™ Magnetic Navigation System environment in cardiac ablation procedures. The CELSIUS^® RMT and NaviStar^® RMT families of Catheters, including the CELSIUS^® and NaviStar^® RMT ThermoCool^® Catheters, are the only magnetic catheters accurately matched to the navigational software of the Niobe™ System for optimal performance and highly precise catheter manipulation.

“Gaining distribution rights to Stereotaxis’ Odyssey™ portfolio of products will provide electrophysiology labs an unparalleled and unique enterprise solution for integrating, recording and networking interventional lab information within hospitals and around the world. We are excited at the opportunity that this extended collaboration will bring for electrophysiologists and the patients that they treat,” concluded Nachman.