Industry News and Products

New Drug Application Submitted to FDA for Rivaroxaban for Prevention of Stroke in Patients with Atrial Fibrillation

Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD) announced that it has submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for rivaroxaban, an investigational, oral, once-daily anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). The submission is supported by data from the pivotal, global Phase 3 ROCKET AF (Rivaroxaban Once daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for prevention of stroke and Embolism Trial in Atrial Fibrillation) trial. AF is the most common sustained cardiac rhythm disorder, affecting more than 2.3 million people in the U.S. In patients with AF, the heart’s irregular beat makes them vulnerable to the formation of blood clots in the atria, which can travel to the brain, potentially resulting in a stroke. Strokes can lead to major physical and behavioral impairments, or even death. People living with AF are at a five-fold increased risk for stroke compared with the general population, and almost one-third will suffer from a stroke in their lifetimes. J&JPRD also announced that it has submitted its complete response to the FDA seeking approval to use rivaroxaban for the prevention of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing total hip or total knee replacement surgery. The submission includes specific information requested by the FDA in a complete response letter issued to J&JPRD on May 28, 2009, and is primarily supported by data from the pivotal, global Phase 3 RECORD (REgulation of Coagulation in major Orthopedic surgery reducing the Risk of DVT and PE) clinical trial program. More information about the rivaroxaban clinical development program, and the diseases for which it is being developed, may be accessed at https://www.jnjpharmarnd.com/jnjpharmarnd/rivaroxaban.html About Rivaroxaban. Rivaroxaban is a novel oral anticoagulant being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. In clinical studies, the compound has shown no requirement for routine laboratory coagulation monitoring, and limited risk for food and drug interactions. The extensive program of clinical trials evaluating this compound makes rivaroxaban the most studied oral, direct Factor Xa inhibitor in the world today. By the time of its completion, more than 65,000 patients will have participated in the rivaroxaban clinical development program. Rivaroxaban is being developed jointly by Johnson & Johnson Pharmaceutical Research & Development, L.L.C., which is part of the Johnson & Johnson Family of Companies, and Bayer HealthCare AG.

Endosense Launches the TOCCASTAR IDE Study of Its TactiCath^® Force-Sensing Ablation Catheter

Endosense has announced first patient enrollment in the TOCCASTAR (TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation) clinical study at Na Homolce Hospital, Prague, Czech Republic, by study investigator Petr Neuzil, MD. TOCCASTAR is a prospective, randomized, multi-center, investigational device exemption (IDE) clinical trial designed to evaluate the effectiveness and safety of the TactiCath¹ force-sensing ablation catheter for the treatment of symptomatic paroxysmal atrial fibrillation (AF). Results of the study will be used to support a Premarket Approval Application (PMA) to the U.S. Food and Drug Administration (FDA) for clearance of the TactiCath catheter and accompanying TactiSys system. TOCCASTAR will be conducted at up to 30 centers in the United States and Europe. Three hundred patients will be randomized on a one-to-one basis for treatment with Endosense’s force-sensing TactiCath or a catheter approved by the FDA for paroxysmal AF. The study’s primary effectiveness endpoint will measure acute procedural success as well as chronic freedom from symptomatic AF, atrial tachycardia and atrial flutter at 12 months. The safety endpoint will report the incidence of device-related serious adverse events. In addition, TOCCASTAR will assess the contribution of real-time contact force information to procedural effectiveness during ablation compared to conventional radiofrequency (RF) irrigated catheters. “This is a very exciting time for Endosense, as we embark on this critical step toward regulatory clearance for the TactiCath in the United States,” said Eric Le Royer, Endosense president and chief executive officer. “Based on the significant and growing foundation of clinical evidence we have built with the TactiCath contact force-sensing catheter, as well as our commercial success in Europe, we expect the results of TOCCASTAR to continue to demonstrate the great potential of contact force sensing to profoundly improve and expand the catheter ablation treatment of cardiac arrhythmias.” AF is the most common cardiac rhythm disorder today, affecting more than six million people worldwide. TOCCASTAR will explore a new catheter ablation treatment option for patients who have symptomatic paroxysmal (sudden and temporary) AF and who are resistant or intolerant to at least one Class I-IV anti-arrhythmic drug. “The ability of physicians to control contact force during ablation procedures has long been a missing link in catheter ablation, and the consequence of this has been an historic trade-off between procedure safety and effectiveness,” said Vivek Reddy, MD, TOCCASTAR principal investigator and director of the Cardiac Arrhythmia Service, The Mount Sinai Medical Center, New York. “TOCCASTAR is a landmark study in that its results may pave the way for contact force sensing to become the new standard of care in radiofrequency catheter ablation, a development that would finally address this issue and ultimately help improve safety, effectiveness and access to the procedure.” About catheter ablation and the TactiCath. During catheter ablation, the electrophysiologist uses a catheter to create a series of lesions along the heart wall to disrupt abnormal electrical activity. With no way to objectively measure the contact force between the catheter tip and beating heart wall, the electrophysiologist has to estimate — and frequently guess — the level of force required. This creates a delicate balancing act between procedure effectiveness and safety, as too little force may render the procedure ineffective and too great a force may perforate the heart wall. Endosense’s TactiCath is the first and only commercialized force-sensing ablation catheter to give physicians a real-time, objective measure of contact force during the catheter ablation procedure. Launched outside of the United States in April 2010, the second generation TactiCath is now used by electrophysiologists across Europe. A growing body of evidence has reinforced the value of force sensing in improving patient outcomes of catheter ablation procedures and has supported the TactiCath’s potential to improve the effectiveness, safety and accessibility of catheter ablation treatment of cardiac rhythm disorders, including AF. BIOTRONIK is the exclusive distributor of the TactiCath in Europe, Latin America, Canada, Africa and the Middle East. The TactiCath is not yet available in the United States. ¹Caution: TactiCath is an investigational device. Limited by Federal (or United States) law to investigational use.

nContact Surgical, Inc. to Operate as nContact, Inc.

nContact Surgical, Inc. (nContact) announced that it is changing the name under which it operates from nContact Surgical, Inc. to nContact, Inc. As the pioneer of interdisciplinary epicardial and endocardial cardiac ablation, the change represents the company’s further evolution towards closed chest approaches to treating common cardiac arrhythmias. “nContact’s progressive technology and our ability to continuously provide less invasive epicardial ablation options no longer restricts our device to surgeons,” said John Funkhouser, CEO of nContact, Inc. “By removing ‘Surgical’ from our company name, we are categorically affirming our mission to transform the ablation market and change the dialogue from individual surgical or catheter approaches to interdisciplinary and EP-only approaches that may achieve greater scientific and clinical endpoints.” nContact has consistently enabled the evolution of epicardial ablation procedures that have explored simpler access to the heart while creating complete lesions under direct visibility. Along this pursuit, the Company is credited with pioneering SUBTLE (SUB-thoracic TotaL Endoscopic) access to the heart, which enables a closed chest ablation procedure (without any chest incisions or ports) through a small midline abdominal incision. The primary proprietary advantage of the procedure, which utilizes nContact’s Numeris^® Coagulation System with VisiTrax^®, is its unique integration of suction, perfusion, and RF energy to create visible, continuous lesions on a beating heart. Funkhouser continued, “SUBTLE access is revolutionary in that it offers the first truly minimally invasive, standardized approach to access the posterior of the heart. Yet, as groundbreaking as this is, nContact views this advance as part of an industry progression toward a standalone cardiac ablation market that utilizes combination therapies that access both the epicardial and endocardial surfaces as a means to more effectively treat arrhythmias.” nContact’s technology is being developed further to enable a new sub-xyphoid percutaneous approach to the atria and ventricles through a simple needle puncture, a technique that is familiar to EPs. In effect, the company sees significant opportunity to offer an adaptable epicardial ablation tool that is well-suited to be an essential part of the cardiac EP technology platform. Kenneth C. Civello, MD, Chief of Electrophysiology at Our Lady of the Lake Hospital in Baton Rouge, Louisiana, remarked, “nContact is uniquely positioned, based on a significant scientific foundation, to demonstrate the importance of epicardial ablation to enhance the performance of existing catheter ablation tools. The combined approach is completely synergistic with the extensive technology platform of EPs, as endocardial ablation remains important, and mapping and navigational diagnostics may predict outcomes.”

Biosense Webster Successfully Completes First Clinical AF Ablation Cases in the European Union Using the ThermoCool^® SmartTouch™ Contact Force Sensing Catheter

Biosense Webster, Inc., a Johnson & Johnson company, announced the successful completion of the first clinical cases with the new ThermoCool^® SmartTouch™ Contact Force Sensing Catheter in the European Union, following recent CE Mark approval. The device is pending clinical investigation in the U.S. and the FDA has not yet approved it for sale. The ThermoCool^® SmartTouch™ Catheter is the most advanced catheter developed by Biosense Webster to date. During cardiac ablation, the ThermoCool^® SmartTouch™ Catheter enables the measurement of catheter tip contact force and direction inside the heart. The force and contact information is graphically displayed on the Carto^® 3 Mapping and Navigation System with the Carto^® 3 SmartTouch™ Software Module, thus creating the only fully integrated solution in the electrophysiology market which combines contact force with 3D mapping and navigation capabilities. Dr. Paolo Della Bella, from the San Raffaele Hospital in Milan, Italy, performed the first human cases with the ThermoCool^® SmartTouch™ Catheter and Carto^® 3 System. “This is a breakthrough technology. The force reading parameter gives me additional confidence in my ablation procedures.” The ThermoCool^® SmartTouch™ Catheter combines Biosense Webster’s irrigated ablation technology and the accurate visualization for which the Carto^® 3 System is globally renowned with innovative force-sensing capabilities. By displaying precise contact force and direction information, the ThermoCool^® SmartTouch™ Catheter provides an important new parameter for the mapping and ablation of complex cardiac arrhythmias, such as atrial fibrillation. “ThermoCool^® SmartTouch™ Catheter brings new force reading information to physicians and will provide them with an important new measurement for ablation procedures. This breakthrough technology continues our commitment to bringing advanced tools to the Cardiac Electrophysiology community, so that they may better serve their patients,” said Shlomi Nachman, Worldwide President, Biosense Webster, Inc. Dr. Della Bella is compensated for his services as a member of the company’s scientific advisory board and provides other consulting services.

Vascular Solutions Introduces the SmartNeedle^® Vascular Access System

Vascular Solutions, Inc. recently acquired the SmartNeedle^® Vascular Access system. The SmartNeedle system consists of a hand-held monitor and one-time use needles designed to provide auditory ultrasound guided access to arteries and veins during catheterization procedures. The SmartNeedle monitor is a re-usable, hand-held device that transmits a continuous wave Doppler signal, providing continuous auditory feedback to help locate and access the artery or vein quickly and with confidence. If desired, the monitor can be covered with a disposable sterile bag for use in the sterile field. Sterile, single-use SmartNeedles range from 18G to 24G, with bare tip and sheathed IV options. Bare-tipped needles are available in 18G, 20G and 22G sizes, and consist of a detachable Doppler probe that is housed within the lumen of a standard sized introducer needle. IV sheathed needles, used when attempting to access a vessel with the intent of leaving a small catheter in place, are available in 20G, 22G, 24G and 26G sizes. Acquired by Vascular Solutions from Escalon Medical in May 2010, the SmartNeedle system was formerly known as the pdAccess Doppler guided needle access system. Moving forward, Vascular Solutions will use solely the name SmartNeedle. SmartNeedle products are available in the United States and Europe. Vascular Solutions, Inc. is an innovative medical device company that focuses on developing unique clinical solutions for coronary and peripheral vascular procedures. The company’s product line consists of over 50 products in three categories: catheter products, hemostat products and vein products. SmartNeedle is a registered trademark of Vascular Solutions, Inc.

First-of-its-kind Pacemaker System Proves to be Safe and Effective for Use During Magnetic Resonance Imaging

Results from a large, worldwide, clinical trial show evidence that a first-of-its-kind pacemaker system is safe and effective to use during magnetic resonance imaging (MRI). During the trial, no MRI-related complications were reported in patients with the pacemaker system before, during, or after an MRI examination. The data from the clinical trial, published in the January edition of HeartRhythm, the official journal of the Heart Rhythm Society, proves the ability of this pacemaker system to be exposed in a controlled fashion to MRI without negatively affecting the patient or the system. The randomized, controlled, multicenter clinical trial took place in the United States, Canada, Europe, and the Middle East, and evaluated a complete pacemaker system — pacemaker, leads, and programming of device — that was specifically designed for safe use in MRI. After successful pacemaker implantation, a total of 464 patients were randomly placed into two groups — a controlled group who would not undergo MRI, and an MRI group. Patients in the MRI group underwent MRI examinations in a 1.5-T scanner. Both groups were evaluated one week and one month post-MRI to determine whether or not any complications occurred that could be attributed to the MRI scanning. Of the patients in the MRI group, 100 percent were free of MRI-related complications. The MRI scans were completed safely, delivering continuous pacemaker stimulation or regular spontaneous intrinsic activation when programmed to the proper mode. None of the patients in the MRI group experienced adverse effects that have been known to occur in pacemaker patients who undergo an MRI. Results of the trial were as follows: During and/or after the MRI: • no inhibition of pacemaker output or cardiac arrest • no sustained ventricular arrhythmias • no unexpected changes of heart rate • no electrical resets • no pacemaker system disturbances and • no sensation of torque or pain “Today, MRI scanning is used across many fields of medicine to help clinicians accurately diagnose patients to ensure each patient is treated properly and effectively,” stated Bruce L. Wilkoff, MD, FHRS, president-elect of the Heart Rhythm Society, Department of Cardiovascular Medicine at the Cleveland Clinic. “At the same time, the number of people living with cardiac devices is increasing and we find ourselves in need of devices that are compatible with MRI scanning. This pacemaker system is truly the first to be designed specifically for safe use in an MRI environment.” In a proper and controlled environment, this pacemaker system has proven to be safe during MRI scanning when used in accordance with its labeling. There were no disturbances of pacemaker function and no ventricular arrhythmia induction observed in this clinical trial. For more information about this trial, please visit www.heartrhythmjournal.com

Stereotaxis Announces CE Mark and First Human Case for Vdrive™

Stereotaxis, Inc. announced the first successful cardiac ablation procedure with the Vdrive™ robotic navigation system as the company received CE Mark for this latest innovation. In the first procedure with the Vdrive system, Tamas Szili-Torok, MD, PhD, from the Department of Clinical Electrophysiology at the Erasmus Medical Center in the Netherlands, successfully treated atrial fibrillation in a patient with known difficult heart anatomy. Dr. Szili-Torok was able to complete the entire case without having to manually adjust the circular mapping catheter. "This first use of the Vdrive robotic navigation system exceeded my expectations," said Dr. Szili-Torok. "The robotic navigation of the circular mapping catheter was intuitive and allowed me to make multiple small precise adjustments from the control room to efficiently treat my patient's atrial fibrillation." Stereotaxis' Vdrive system is a robotic navigation technology that compliments the Stereotaxis Remote Magnetic Navigation System. Designed to manipulate accessory devices such as variable loop catheters, steerable sheaths, and ultrasound catheters, Vdrive combines magnetic navigation with the Odyssey information management system to bring precise control during catheter-based electrophysiology procedures. "The Vdrive system is an extension of the magnetic navigation platform capabilities," said Michael P. Kaminski, President and Chief Executive Officer of Stereotaxis, Inc. "Along with QuickCAS™ Catheter Advancement System, the Vdrive system represents an additional component to our expanding disposable product portfolio designed to bring compelling efficiency to the electrophysiology lab." The Vdrive system is commercially available in the European Union. The Vdrive system is not currently available for purchase in the U.S. as it is still under 510(k) review by the U.S. Food and Drug Administration.

TYRX, Inc. Raises $20 Million in Private Financing: Proceeds will Support Continued Commercialization of the AIGISRx^® Antibacterial Envelope and Development of Next Generation Products

TYRX, Inc., the leader in the commercialization of implantable medical devices designed to help reduce surgical-site infections associated with implantable pacemakers and defibrillators, announced that it has raised $20 million in venture capital funding. The funding was led by new investor, HLM Venture Partners, along with previous investors Clarus Ventures and Pappas Ventures. The financing round also included $4 million in debt financing from Comerica Bank. In connection with the financing, Edward L. Cahill, Managing Partner, HLM Venture Partners, will join TYRX’s Board of Directors. “This continued investment from Clarus and Pappas Ventures, along with participation from new TYRX investor HLM Venture Partners, is a strong validation of TYRX’s products and business strategy,” stated Robert White, TYRX’s Chief Executive Officer. “During 2010 we have reached a number of key milestones in a transformational year for TYRX including:

Successfully implanting the AIGISRx® device in over 13,000 patients.
• Realization of over $10M in AIGISRx revenue since commercial launch, growing nearly 100% in 2010.
• Publication of our first human clinical trial data on 642 patients showing a 99.5% rate of successful implantation and demonstrating 70% fewer infections than some previous studies within the highest risk cohort of implantable defibrillator replacements. The study also showed no infections in patients receiving initial implantations of pacemakers or implantable defibrillators.
• Completion of the enrollment phase at 50 clinical study sites in 2 major new studies designed to measure infections and mechanical complications associated with implantable defibrillators. These studies will enroll a total of 4,300 patients.
• U.S. Food and Drug Administration (FDA) 510(k) clearance to market AIGISRx ST, an antibacterial product for the surgical repair of damaged or ruptured soft tissue.”

“We are excited to be partnering with Clarus and Pappas Ventures to finance TYRX in the pursuit of making AIGISRx the standard of care in the cardiac rhythm management space,” commented Mr. Cahill. “With over 500,000 critically important pacemakers and defibrillators being implanted annually in the United States, and an infection rate that is growing much faster than the growth in procedures, TYRX has a unique and powerful solution. Each infection typically costs between $28,000 and $58,000 but can exceed $100,000. In addition, major infections carry a very high risk of death with 1-year patient mortality recently reported to be over 17%. TYRX is the leader in addressing this important patient safety issue and offers a meaningful improvement in the quality of patient care.”

Many Patients With Implantable Cardioverter-Defibrillators Do Not Meet Criteria For Use

A study that included more than 100,000 patients who received implantable cardioverter-defibrillators (ICDs) found that about 20 percent did not meet evidence-based guidelines for receipt of an ICD, and that these patients had a significantly higher risk of in-hospital death than individuals who met criteria for receiving an ICD, according to a study in the January 5 issue of JAMA. Several randomized controlled trials have shown the effectiveness of ICDs for preventing sudden cardiac death in patients with advanced systolic heart failure. But practice guidelines do not recommend use of an ICD for primary prevention in patients recovering from a heart attack or coronary artery bypass graft surgery and those with severe heart failure symptoms or a recent diagnosis of heart failure. “The degree to which physicians in routine clinical practice follow these evidence-based recommendations is not clear,” the authors write. Sana M. Al-Khatib, MD, MHS, of the Duke Clinical Research Institute, Durham, N.C., and colleagues conducted a study to determine the number, characteristics, and in-hospital outcomes of patients who received a non-evidence-based ICD. The study included an analysis of cases submitted to the National Cardiovascular Data Registry-ICD Registry between January 2006 and June 2009. The researchers found that of 111,707 initial primary prevention ICD implants that occurred during the study period, 25,145 were for a non-evidence-based indication (22.5 percent). Of these, 9,257 were in patients within 40 days of a heart attack (36.8 percent) and 15,604 were in patients with newly diagnosed heart failure (62.1 percent). The risk of in-hospital death was significantly higher in patients who received a non-evidence-based device than in patients who received an evidence-based device (0.57 percent vs. 0.18 percent). The risk of any postprocedure complication was significantly higher in the non-evidence-based ICD group at 3.23 percent compared with 2.41 percent in the evidence-based group. “Although the absolute difference in complications between the 2 groups is modest, these complications could have significant effects on patients’ quality of life and health care use, including length of hospital stay and costs. Importantly, these complications resulted from procedures that were not clearly indicated in the first place. While a small risk of complications is acceptable when a procedure has been shown to improve outcomes, no risk is acceptable if a procedure has no demonstrated benefit,” the authors write. Any adverse event and death were significantly higher in patients who received a non-evidence-based device. The median (midpoint) length of hospital stay was significantly longer for patients who received a non-evidence-based ICD compared with patients who received an evidence-based ICD (3 days vs. 1 day). Also, there was substantial variation in non-evidence-based ICDs by site. The proportion of ICD implants performed by the different types of physician specialty was 66.6 percent for electrophysiologists, 24.8 percent for nonelectrophysiologist cardiologists, 2.6 percent for thoracic surgeons, and 6.1 percent for other specialists. The rate of non-evidence-based ICD implants was significantly lower for electrophysiologists (20.8 percent) than nonelectrophysiologists (24.8 percent for nonelectrophysiologist cardiologists; 36.1 percent for thoracic surgeons; and 24.9 percent for other specialties). There was no clear decrease in the rate of non-evidence-based ICDs over time. “During this period of limited resources and due to the Centers for Medicare & Medicaid Services’ emphasis on quality improvement by promoting evidence-based care, it is increasingly important to assess hospital performance and to provide feedback to hospitals about their outcomes and compliance with clinical guideline recommendations. Providing such feedback to hospitals has the potential to improve adherence to practice guidelines and eventually patient outcomes,” the researchers write, “… more efforts should focus on enhancing adherence to evidence-based practice.” JAMA 2011;305[1]:43-49.