New Radiation Protection Products Approved for Device Implants
LEMER PAX announced the CE Mark and market release of three new versions of its CATHPAX Radiation Protection Cabin. Like the original CATHPAX radiation cabin, which was designed for ablation procedures, the new devices provide greater than 99.9% protection from scatter radiation.
“We are very excited to release these new products, which are the culmination of years of development and testing — and dramatically expand the types of procedures physicians can do under maximum radiation protection. These are significant advances in versatility, with new applications for electrophysiologists, but also cardiologists and interventional radiologists,” said Pierre-Marie Lemer, president and CEO of LEMER PAX.
Two of the new CATHPAX devices provide greater flexibility and freedom of movement to perform device implantations and include both one- and two-operator versions. The two-operator device allows physicians to work side-by-side inside the radiation protection cabin, both protected by a control-room-level of radioprotective glass. The third device is a new version of the CATHPAX ablation cabin that allows physicians to sit during procedures, to provide greater comfort during long ablation cases.
LEMER PAX’s products, including the multipurpose device cabin, will be exhibited at the upcoming Heart Rhythm Society meeting in Boston, May 9th through 11th, in booth #1300, hosted by Anthem Medical.
Boston Scientific Announces U.S. Launch of Z Flex-270™ Steerable Sheath
Boston Scientific Corporation announced the U.S. market launch of its Z Flex-270™ Steerable Sheath. The device is intended for use in a wide range of electrophysiology procedures to facilitate the introduction and placement of diagnostic and therapeutic catheters within the heart. The company plans to launch the product immediately in the U.S.
“The Z Flex-270 Steerable Sheath provides more than 270 degrees of tip deflection to allow access to difficult-to-reach areas in all four chambers of the heart. This high degree of bend, combined with a very responsive steering mechanism, should provide additional flexibility for maneuvering inside the cardiac space,” said Bruce G. Hook, MD, Director, Cardiac Arrhythmia Service at the Lahey Clinic Medical Center in Burlington, MA. “We look forward to using the Z Flex-270 Steerable Sheath in our institution.”
“The Z Flex-270 Steerable Sheath is designed to facilitate delivery and placement of interventional devices used to treat atrial fibrillation and other complex arrhythmias,” said Pete Sommerness, vice president and general manager of Boston Scientific’s Electrophysiology business. “The launch of the Z Flex-270 Steerable Sheath complements our growing EP portfolio and highlights our continued focus on providing the most advanced technologies.”
The Z Flex-270 Steerable Sheath is compatible with catheters up to 12 French.
Atrial fibrillation, which affects approximately 15 million patients worldwide, is an arrhythmia associated with a rapid rhythm in the upper chambers of the heart. Patients are most often treated with anti-arrhythmic drugs, which can often cause adverse side effects. Cardiac ablation with a radiofrequency ablation catheter is increasingly becoming an option for patients who cannot tolerate these medications.
Boston Scientific currently has no FDA-approved cardiac ablation catheters for the treatment of atrial fibrillation.
TYRX CITADEL/CENTURION Clinical Studies Enroll 1000th Patient
TYRX®, Inc., the leader in the commercialization of implantable medical devices designed to help reduce surgical-site infections (SSIs) associated with cardiovascular implantable electronic devices (CIEDs), announced that the 1000th patient has been enrolled into the CITADEL & CENTURION clinical studies evaluating the company’s AIGISRx Antibacterial Envelope.
CITADEL & CENTURION are prospective, multicenter clinical studies, designed to enroll 4,300 subjects at over 50 U.S. study sites. The studies are evaluating the use of AIGISRx in patients who are at high risk for CIED infection because their current CIED is being replaced with either an implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy (CRT) device accompanied by the AIGISRx.
The primary endpoints for both studies are 1) major ICD/CRT device-related infections and 2) ICD/CRT device-related mechanical complications. Patients will be followed for 12 months, with pre-defined interim analyses at 3 and 6 months.
The AIGISRx Envelope is a mesh device that securely holds a pacemaker or ICD, creating a stable environment surrounding the device and leads after surgical placement. The biocompatible mesh is coated with antibiotic agents rifampin and minocycline, which elute over a 7- to 10-day period to help reduce infections associated with CIED implantation.
“CIED infections present substantial challenges to patients and the physicians who care for them. CITADEL & CENTURION are large prospective studies enrolling patients at community, academic, and VA medical centers. These studies are important because they will generate useful clinical information on the use of AIGISRx in a wide variety of patients at high risk for CIED infection,” stated Walter Paladino, MD, FACC, St. Elizabeth Hospital, Youngstown, OH.
TYRX Chief Medical Officer, Daniel Lerner, MD, commented that “CIED infections are associated with substantial morbidity, mortality, and cost, and are increasing in frequency. The risk of CIED infection is significantly increased in patients who receive a replacement device. The CITADEL & CENTURION studies are large prospective studies that will provide useful data on the clinical performance of the AIGISRx in these patients.”
The CITADEL (NCT01043861) & CENTURION (NCT01043705) studies are registered in the ClinicalTrials.gov registry of federally and privately supported clinical trials conducted in the U.S. and around the world (www.ClinicalTrials.gov).
About TYRX, Inc.
TYRX, Inc. commercializes innovative, implantable combination drug+device products focused on infection control, including the AIGISRx® Antibacterial Envelope, designed to reduce surgical-site infections associated with CIEDs. AIGISRx products contain antimicrobial agents, rifampin and minocycline, which have been shown to reduce infection by organisms representing a majority of the infections reported in implantable pacemaker and defibrillator related endocarditis, including “superbugs” or MRSA*. Following commercial release, the AIGISRx Envelope has been used in over 25,000 patients nationwide. The company estimates that over 2% of all U.S. implantable pacemaker and defibrillator patients in 2012 will receive an AIGISRx product during their procedure.
TYRX, Inc. is an ISO 13485:2003 certified medical device manufacturer and its products utilize technology licensed exclusively from Rutgers, Baylor College of Medicine, and The University of Texas M. D. Anderson Cancer Center.
* Based upon preclinical in vitro and in vivo data. Data on file at TYRX and published in PACE 2009;32:898-907.
Estech Announces FDA Approval to Begin Enrollment in ATTAC-AF IDE Trial for the Treatment of Atrial Fibrillation During Cardiac Surgery
Estech, a leader in minimally invasive and endoscopic cardiac ablation, announced that the FDA has given conditional Investigational Device Exemption (IDE) approval to initiate patient enrollment in the Estech-sponsored ATTAC-AF trial. The IDE trial has been designed to evaluate the treatment of atrial fibrillation (AF) utilizing temperature-controlled radiofrequency (TCRF) ablation in patients undergoing cardiac surgery. Up to 15 centers in the U.S. and Europe will participate in the trial, which is intended to enroll over 100 cardiac surgery patients.
The ATTAC-AF trial will enroll cardiac surgery patients who have a history of non-paroxysmal AF. During the cardiac surgical procedure for treatment of coronary or valve disease, patients will also be treated for their atrial fibrillation disease with Estech’s COBRA® Ablation probes utilizing patented TCRF technology. Patients enrolled in the ATTAC-AF trial will be followed for a minimum of one year to determine the success rate for preventing recurrence of AF and to assess the patient’s quality of life following the ablation procedure.
For patients referred for cardiac surgery, non-paroxysmal atrial fibrillation is exceptionally important because its associated morbidity causes significantly poorer survival rates compared to patients with normal sinus rhythm (NSR). Approximately 30–40% of patients undergoing mitral valve repair have pre-existing non-paroxysmal AF. Patients in NSR following mitral valve operation have increased one- and four-year survival rates compared with those in AF. The increased rates of morbidity and mortality associated with patients who remain in AF after surgery demonstrate the need for an effective and reliable treatment for AF.
“This is a very important study to get the indication to treat atrial fibrillation surgically,” said the principal investigator Niv Ad, MD, Chief of Cardiac Surgery and Director of Cardiac Surgery Research at Inova Heart & Vascular Institute, Virginia. “I have found Estech’s temperature-controlled RF technology to be of very high quality,” Dr. Ad continued. “With the anticipated participation of some of the best cardiac surgery centers in the U.S. and Europe, this promises to be an excellent study.”
Estech develops and markets a broad 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 COBRA line comprises the first technology invented, developed and brought exclusively to the surgical ablation market. Temperature-controlled RF energy delivery, suction-assisted tissue contact and internally-cooled devices provide superior ablation performance compared to other ablation systems.
COBRA® Surgical System: Disclaimer
In the U.S., the COBRA Adhere XL, COBRA Cooled and COBRA Surgical probes have been cleared for cardiac ablation. The Estech COBRA Revolution has been cleared for ablation of soft tissues. The AFfirm Pacing Probe has been cleared to be used upon completion of the cardiac ablation procedure to assess the adequacy of cardiac lesions created in surgically treating the patient’s arrhythmia. Estech does not promote off-label use of its products and their use is at the discretion of the cardiac surgeon. Estech has received conditional IDE approval from FDA to begin enrollment in a clinical trial to support a Premarket Approval (PMA) submission in the U.S. to obtain a specific atrial fibrillation indication for several products. In Europe, the Estech COBRA RF ablation products are CE marked with an indication for the treatment of atrial fibrillation by ablating cardiac tissue during surgery.
St. Jude Medical Issues Physician Communication about QuickSite and QuickFlex LV CRT Leads
St. Jude Medical, Inc., a global medical device company, announced it is proactively informing physicians about visual observations of externalized conductors on the silicone end of QuickSite® and QuickFlex® Left-Ventricular (LV) Leads, used to connect cardiac resynchronization therapy (CRT) devices to the heart.
There have been no reports of patient injury or loss of therapy due to externalized conductors in these leads, but as a conservative measure, St. Jude Medical is communicating with physicians about the incidence rate so they have the most updated lead performance information with which to make important patient care decisions. The company will no longer sell these lead models. It is important to note, however, that the overall safety and reliability of QuickSite and QuickFlex leads continues to be comparable to currently available CRT leads from other manufacturers.
A copy of the physician letter and additional information about these leads can be found on sjmprofessional.com.
An LV lead is placed on the lower left chamber of the heart to stimulate the two sides of the heart to beat in synchronization with each other, which helps the heart to beat more efficiently. These LV leads are intended to improve the efficiency of the heart in patients with heart failure, but are not responsible for delivering immediate life-sustaining pacing or lifesaving defibrillation therapy. If an LV lead were to fail, the other leads attached to the patient’s device would continue to deliver lifesaving therapy.
St. Jude Medical has confirmed 39 cases of externalized conductors, out of 171,000 QuickSite and QuickFlex leads sold worldwide, resulting in a current reported incidence rate of 0.023 percent, or 2.3 in 10,000. Because these leads continue to function normally, the company expects that this rate is under-reported. Based on an analysis of leads returned to the company and recent fluoroscopic images of implanted leads still in clinical use, St. Jude Medical estimates that 3 to 4 percent of QuickSite and QuickFlex leads may exhibit externalized conductors. As a result of this estimated rate, the company felt it was prudent to communicate with physicians about the externalized conductors at this time.
This medical device advisory does not affect the company’s continued sale of its newer QuickFlex µ (micro) or Quartet® LV leads, which are fully insulated using Optim® insulation along the entire length of the lead body. Optim insulation is a hybrid material that combines the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane, to provide increased durability and flexibility. There have been no reports or observations of externalized conductors in these newer Optim-insulated leads, out of over 65,000 of these leads sold worldwide since 2008.
An externalized conductor occurs when the cable, or conductor, from inside the lead wears through the outer silicone insulation around the lead and appears outside the insulation body. This can be visualized on an x-ray or fluoroscopic image; however, these cables are protected by an additional layer of insulation, and therefore can continue to function properly if an externalization occurs.
Medtronic Receives FDA Approval to Treat Mildly Symptomatic Heart Failure Patients Through Expanded Indication for CRT-D
Medtronic, Inc. announced that the U.S. Food and Drug Administration (FDA) approved an expanded indication for its cardiac resynchronization therapy with implantable cardioverter defibrillator (CRT-D) devices. With this approval, this advanced therapy can now be used earlier, in a mildly symptomatic heart failure patient population, potentially improving survival, reducing hospitalizations, and preventing disease progression.
The expanded indication includes New York Heart Association (NYHA) Class II heart failure patients with a left ventricular ejection fraction (LVEF) of less than or equal to 30 percent, left bundle branch block (LBBB), and a QRS duration greater than or equal to 130 milliseconds. Nearly 200,000 Americans are considered NYHA Class II, with another 620,000 people worldwide fitting this designation. Medtronic CRT-D devices were previously indicated to treat certain patients with moderate-to-severe heart failure (NYHA Class III and IV), and have safely and effectively been used in these patients for more than a decade.
The FDA’s decision for the expanded indication rests on data from the pivotal REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) and landmark RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure Trial) clinical trials, which showed that CRT-D can benefit mildly symptomatic heart failure patients by reducing mortality and heart failure hospitalization rates.
“The RAFT and REVERSE study findings provide strong clinical evidence validating the safety, efficacy and lifesaving benefits of CRT-D for treating systolic heart failure patients with milder symptoms,” said Michael R. Gold, MD, PhD, REVERSE study investigator and steering committee member, Michael E. Assay professor of medicine and director of cardiology at the Medical University of South Carolina. “This expanded indication fulfills an unmet need by treating these patients in the earlier stages of heart failure, before their symptoms more significantly impact their quality of life.”
While certain NYHA Class II patients are already indicated for an implantable cardioverter defibrillator (ICD) to protect them from sudden cardiac arrest (SCA), they are still vulnerable to experiencing an exacerbation of their heart failure. In fact, SCA is responsible for more than 60 percent of deaths among patients with mild-to-moderate heart failure. However, a growing body of clinical research suggests that earlier intervention with CRT-D can decrease the risk of morbidity and mortality in this mildly symptomatic patient population. CRT-D therapy works by resynchronizing the contractions of both ventricles by sending tiny electrical impulses to the heart muscles, which improves the heart’s blood-pumping ability. The device also has defibrillation capability, allowing for termination of life-threatening ventricular arrhythmias.
“Medtronic is pleased with the FDA’s decision to expand the use of the company’s innovative portfolio of CRT-D devices to treat thousands of patients with mildly symptomatic, Class II heart failure,” said David Steinhaus, MD, Vice President and General Manager, Heart Failure, and Medical Director for the Cardiac Rhythm Disease Management business. “We are fully committed to enhancing patient outcomes through our extensive portfolio of advanced medical devices that have been proven safe, effective and efficient in treating heart failure patients across the continuum of care.”
The company will be embarking on a post-approval study to further substantiate the clinical benefits of CRT-D treatment in the Class II heart failure patient population. To date, Medtronic has supported eight major heart failure trials that have contributed to the continued development and broadening of evidence-based treatment guidelines.
About the RAFT Trial
Findings from the landmark RAFT clinical trial, published in the New England Journal of Medicine, showed that CRT-D significantly reduced mortality for mildly symptomatic heart failure patients (NYHA Class II) by 29 percent when compared to patients treated with guideline-recommended implantable ICDs and medical therapy (p=0.006; HR=0.71). The study also demonstrated a significant reduction (27 percent) in combined mortality and heart failure hospitalizations for this population (p=0.001; HR=0.73), consistent with previously published studies. All patients were followed for at least 18 months, and had an average follow-up of 40 months, making it the longest follow-up and largest patient months-of-experience of any study of CRT therapy.
About the REVERSE Trial
With 610 patients studied, REVERSE was the first large-scale, global, randomized, double-blind trial to demonstrate the impact of CRT in mild heart failure patients or asymptomatic patients who previously had heart failure symptoms. All randomized subjects received a score of improved, unchanged or worsened, utilizing the Clinical Composite Response. For the pre-specified primary endpoint, the results showed that 21 percent of subjects without CRT worsened, compared to 16 percent with CRT (p=0.10); however, post-hoc analyses demonstrated that collectively comparing all the classifications of improved, unchanged or worsened was significant (p=0.004). Importantly, more patients in the trial improved with CRT than without (54 percent vs. 40 percent, respectively). Additionally, the analysis of pre-specified secondary endpoints in the REVERSE trial showed that CRT leads to improvement in both cardiac structure and function as measured by echocardiography, meaning the heart size improves and beats more effectively. CRT also delayed the time to first heart failure hospitalization in this patient group and reduced heart failure hospitalization or all-cause death by 51 percent (p=0.004, post-hoc).
Access Point Technologies USA Announces CE Approval and Launch of Their Full Line of Map-iT™ Diagnostic and Ablation Catheters in Europe
Access Point Technologies USA announced CE approval and launch of their full line of Map-iT™ diagnostic and ablation catheters in Europe.
The APT Map-iT™ catheters incorporate unique shaft and handle technologies that give the doctors superior handling and control while navigating through the heart chambers. “The Map-iT™ catheters have been doing exceptionally well in the Asian market, and we are very excited to expand into Europe in 2012 and into the U.S. market by 2013. We have aligned our company with several respected groups, and are positioned to make a strong start in the European market,” commented Steven Berhow, President and CEO of APTUSA.
“Our technology and rapid development capabilities should help us to quickly gain the confidence of electrophysiologists. We have seen incredible growth in sales of our products in the last five years, and expect that trend to continue with having achieved CE approval. We will continue to work with physicians to develop new and improved products they need for this market.”
The Map-iT™ diagnostic catheters include a full line of fixed curve and steerable catheters with superior handling capabilities. The APT ablation catheter line provides physicians with exceptional handling capabilities and has been quickly adopted. The Map-iT™ catheters come in a wide range of electrode, spacing and curve configurations to meet physicians’ preferences — including 3F sizes.
APTUSA will exhibit in booth #1300 at the annual Heart Rhythm Society meeting, May 9th through 11th in Boston, Massachusetts.
APTUSA is a manufacturer of specialty medical products headquartered in Rogers, Minnesota. APT offers a wide range of products for Interventional Radiology, Vascular Surgery, Interventional Cardiology, Vascular Access, etc., and services including early stage medical device development, cleanroom manufacturing, clinical support and global sales and marketing. APT products are sold globally through a combination of direct sales representatives and premier distributors.
BIOTRONIK REPLACE Study Establishes New Benchmarks for CIED Replacement
The BIOTRONIK sponsored REPLACE study1,2 is the first prospective, multicenter trial to examine a broad range of complications related to replacement of all companies’ cardiovascular implantable electronic devices (CIED) which includes both pacemakers and ICDs. REPLACE demonstrates BIOTRONIK’s ongoing commitment to supporting landmark trials of major significance to the entire medical community.
The REPLACE study enrolled a total of 1,744 patients in 72 centers located across the United States, dividing them into two cohorts: one undergoing generator (implantable device) replacement only (1,031 patients) and another undergoing generator replacement with a new transvenous lead addition or revision (713 patients). Postoperative wound assessment was completed after three months and six months, with a full 100% of patients having received preoperative antibiotics.
The incidence of overall infection was low at six months, with only 1.3% of patients suffering these complications. Major infections contributed 0.8% to the overall rate. “The systematic collection and adjudication of infectious complications provided a very accurate assessment of the risks of infection,” according to Dr. Daniel Z. Uslan, Infectious Diseases specialist at the University of California (UCLA), Los Angeles, and lead author on the study. “Patients can be effectively counseled about the risk of infection following CIED replacement.”
The results revealed an intriguing clustering of infections within the study sites. Eighteen percent of sites (13 of the 72 centers) had patients with infection complications, and 6 of those 13 sites had an incidence rate of more than 5% of enrolled patients. The patients within these 6 sites accounted for 14 (64%) of the 22 total infections experienced during the study. Further investigation of aseptic technique as a potential causal factor revealed that sites experiencing higher infection rates were more likely to use povidone-iodine instead of chlorhexidine for topical antisepsis.
Comorbidities, as measured by the Charlson Comorbidity Index (CCI), were also more prevalent in the patient cohorts from these six centers.
Furthermore, the study showed patients with infections were more likely to have had postoperative hematomas than those without infection (22.7% versus 0.98%), and patients receiving abdominal generator replacements had higher infection rates. Infection prevention strategies such as postoperative systematic antibiotics were widely used.
“REPLACE was the first study to systematically show the current state of practices for infection prevention for CIED implantation,” noted Dr. Uslan. “Practices such as postoperative systemic antibiotics were widespread despite a lack of data on their efficacy. While this indicates a commitment to prevent infection among practitioners, it also highlights the need for large randomized trials examining the potential benefits and risks of these practices.”
“The REPLACE Registry demonstrates BIOTRONIK’s commitment as a leader in clinical excellence,” commented Kevin Mitchell, BIOTRONIK’s Vice President of Clinical Studies, BIOTRONIK, Inc., USA. “We invest in clinical research of clear significance, rigorously run trials to achieve unquestionable endpoint conclusions, and strive to advance patient care and evidence-based medicine by exploring unanswered questions.” BIOTRONIK has a well-established reputation for support of landmark clinical trials such as TRUST,3,4 IMPACT5 and EchoCRT.6
1Uslan DZ, et al. Cardiovascular Implantable Electronic Device Replacement Infections and Prevention: Results from the REPLACE Registry. PACE 2012;35:81-87.
2Poole JE, et al. Complication Rates Associated With Pacemaker or Implantable Cardioverter-Defibrillator Generator Replacements and Upgrade Procedures: Results From the REPLACE Registry. Circulation 2010;122:1553-1561.
3Varma N, et al. Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: the Lumos-T Safely Reduces Routine Office Device Follow-up (TRUST) trial. Circulation 2010;122:325–332.
4Varma N, et al. Automatic remote monitoring of implantable cardioverter-defibrillator lead and generator performance: the Lumos-T Safely RedUceS RouTine Office Device Follow-Up (TRUST) trial. Circ Arrhythm Electrophysiol 2010;3:428–436.
5Ip J, et al. Multicenter randomized study of anticoagulation guided by remote rhythm monitoring in patients with implantable cardioverter-defibrillator and CRT-D devices: Rationale, design, and clinical characteristics of the initially enrolled cohort: The IMPACT study. Am Heart J 2009;158:364-370.e1.
6Van Bommel RJ, et al. Association of intraventricular mechanical dyssynchrony with response to cardiac resynchronization therapy in heart failure patients with a narrow QRS complex. Eur Heart J 2010;31:3054–3062.