CryoCor (San Diego) reported the publication of a European study of atrial fibrillation (AF) patients treated with its Cardiac Cryoablation System to evaluate the role of atrial flutter (AFl) in the recurrence of AF and the effectiveness of an ablation strategy focused on isolating the pulmonary veins to treat the AF.
The study, published in the Dec. 11, 2007, issue of Circulation, prospectively evaluated the best catheter ablation strategy in patients with paroxysmal AF with and without concomitant right AFl. During follow-up averaging 26 months, the authors found that electrical isolation of the pulmonary veins by catheter ablation was successful in patients without concomitant AFl at an 82% success rate.
In patients with concomitant AFl, the combination of ablation for AFL and pulmonary vein isolation alone to treat AF was frequently insufficient in preventing recurrences of AF (recurrence rate of 67%).
The authors concluded that those patients with AFl and AF may require additional sites of ablation to effectively treat their atrial fibrillation.
Luz-Maria Rodriguez, MD, senior author of the study, said, “This is the first time that an ablation strategy for paroxysmal atrial fibrillation and atrial flutter has been systematically studied. This has implications for the tools that a clinician may use to treat these atrial arrhythmias. Based on this study, we do not believe that it will be sufficient to simply isolate the pulmonary veins in a significant proportion of patients.”
Elsewhere in the cardio product pipeline:
• Abiomed (Danvers, Massachusetts) has received approval from the FDA for the iPulse Circulatory Support System, a combination console and disposable balloon that drives Abiomed and other manufacturers’ intra-aortic balloons (IAB), Abiomed’s BVS 5000 and the AB5000 ventricular assist devices (VAD), and the similar technologies of other manufacturers. In response to Abiomed’s pre-market application supplement (PMA-S), the FDA has granted permission to distribute the device for use with patients suffering from acute heart failure. “What’s unique about this product is that iPulse is the only one that does it all. It can be used to provide total circulatory support or for counter-pulsation therapy,” Michael Minogue, president/CEO of Abiomed, told Cardiovascular Devices & Drugs. “It’s more cost effective and already has four DRGs [diagnostic related groups] from $20,000 to $250,000.” The company said the mechanical circulatory system, which will be priced at $95,000, will help it further penetrate markets such as transplant centers and hospitals that do open heart surgeries. Minogue said rollout of the iPulse is expected to begin during 1Q08. Abiomed originally estimated a summer 2007 launch of iPulse in the U.S. Minogue said a lengthy FDA review delayed the launch. Abiomed reported the first treatment of a patient in Europe with its IAB and iPulse console under its recent CE-mark approval. J.P.S. Henriques, MD, a cardiologist at Academic Medical Center (Amsterdam, the Netherlands), used the intra-aortic balloon pump during an angioplasty procedure.
• Berlin Heart (Berlin) reported the first patient enrollment in the prospective investigational device exemption study for its Excor Pediatric VAD (ventricular assist device) device used to treat critically ill pediatric patients suffering from severe heart failure. The multi-center IDE study is to evaluate the safety and probable benefit of using the Excor Pediatric VAD to support Pediatric patients. Excor Pediatric has been designed as a bridge to transplantation for patients waiting for a suitable donor heart, but has also been used as a bridge to recovery when a patient’s heart was able to recover and work on its own again. Unlike standard heart-lung machines, Excor Pediatric has been used as a medium- to long-term support system, supporting failing hearts for up to several months. Berlin Heart makes pumps, cannulas and external components for internal and external use to stabilize cardiac activity in acutely ill patients.
• BioServe (Beltsville, Maryland) reported the introduction of ControlMatch, a new line of fully annotated control DNA and serum samples designed to help biomedical researchers efficiently validate new biomarkers and early-stage clinical trial drug candidates. Leveraging BioServe’s Global Repository of 600,000 human biological samples, ControlMatch allows researchers to select and match control samples to the specific needs of their own DNA and/or serum-based studies. ControlMatch DNA and serum controls will initially cover Type 2 diabetes, hypertension and hyperlipidemia. ControlMatch normal samples for Type 2 diabetes, hypertension and hyperlipidemia are annotated with body mass index, confirmed normal blood glucose levels, confirmed normal blood pressure and cholesterol levels, and a family history of health status and ethnicity determined by data collected on three generations. BioServe makes diagnostic tests for the practice of personalized, predictive and preventive medicine.
• Devax (Lake Forest, California), which develops interventional cardiology devices, said it has completed patient enrollment in the DIVERGE clinical trial evaluating its Axxess Bifurcation Stent System. DIVERGE, a prospective, multi-center trial which enrolled 302 patients, is the largest study conducted to date with a drug-eluting stent (DES), specifically designed for treating bifurcation lesions, areas of atherosclerotic disease occurring at a location where one large vessel divides into two smaller vessels, which may occur in about 20% of all patients undergoing a stenting procedure worldwide. Devax said that, to date, more than 500 patients worldwide have been treated using the Axxess Bifurcation Stent System. The company said that more than 400 patients have received the DES version of the stent.
• FlowCardia (Sunnyvale, California) reported FDA 510(k) clearance and immediate U.S. launch of the Crosser 14P, Crosser 14S and Crosser 18 CTO recanalization catheters. The three peripheral Crosser catheters are endovascular tools used by interventional radiologists, vascular surgeons and interventional cardiologists to cross chronic total occlusions (CTOs) to help restore blood flow to the lower legs. The Crosser is a rapid-exchange catheter delivered over standard .014” and .018” guidewires that uses high-frequency vibration to cross CTOs allowing for subsequent debulking, balloon angioplasty and stent placement. The peripheral Crosser catheters were studied in the FlowCardia PATRIOT Trial. The PATRIOT study principal investigator, Jim Joye, said, “The device worked well in the upper leg and also proved an excellent primary therapy for crossing the more difficult, below the knee occlusions. This new endovascular line of catheters will help us cross lesions that previously could only be treated with a more invasive open surgery.”
• GE Healthcare (Waukesha, Wisconsin) said it now offers improved dose reduction results for both diagnostic cardiac and neuron perfusion computed tomography (CT) exams. GE’s SnapShot Pulse technology for prospectively gated diagnostic cardiac CT exams has been proven to reduce a patient’s radiation exposure by up to 83% and improve image quality, according to GE. The company said its VolumeShuttle technology delivers twice the anatomical coverage (80 millimeters) with up to 24% less radiation exposure compared to a conventional 40 millimeter cine perfusion protocol. Both SnapShot and VolumeShuttle are offered on the GE LightSpeed VCT XT configuration, enabled by a real-time scan control architecture intended to ensure precise control of exposure and table position, the company noted. GE also introduced new editions of its Logiq e compact and a new edition of the Logiq Book XP Enhanced compact. According to the company, Logiq Book XP Enhanced is the third major upgrade of the Logiq Book platform. New features include: new LCD technology with higher resolution, improved off-angle viewing for multiple users, increased brightness and clarity. Faster processing on this new system improves boot-up time by 70%, the company noted. Other faster processing improvements include a 30% faster mode transition, such as changing from black-and-white imaging to color Doplar for vascular applications. GE offers a range of products and services designed to enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier.
• Haemonetics Software Solutions (Braintree, Massachusetts) reported FDA clearance for another software module in the Symphony blood bank management software suite. The Symphony 2.0 software will include a blood component manufacturing and distribution application, in addition to the blood donor management tools included in the previous software release. Symphony 2.0 software is a blood component manufacturing and distribution system which allows blood centers to automate many of the IT processes in their blood supply chain, from the point of blood donation to the point of distribution to the hospital. Specifically, the Symphony software suite includes an automated donor self-interview application and can manage all steps in the collection of blood through manufacturing, labeling and release, inventory management, order entry, and, finally, distribution to the hospital. Haemonetics Software makes blood management solutions.
• Medtronic (Minneapolis) in early January reported d the U.S. market launch of the AneuRx AAAdvantage Stent Graft on the new Xcelerant Hydro Delivery System, which features a hydrophilic coating designed to aid navigation of the device through tight and tortuous arteries by reducing friction with the artery wall. Medtronic said it has also received FDA approval to introduce its latest generation of packaging materials for this product launch. “The Xcelerant Hydro Delivery System is a significant innovation that will make endovascular repair using the AneuRx AAAdvantage Stent Graft a treatment option for more patients with abdominal aortic aneurysms,” said Dr. Frank Arko, MD, chief of Endovascular Surgery at the University of Texas Southwestern Medical Center (Dallas). “It will simplify the procedure for endovascular interventionalists in treating patients whose iliac arteries are difficult to navigate when they are small and tortuous.” The Xcelerant Hydro Delivery System will be used with the company’s AneuRx AAAdvantage Stent Graft, which was introduced in the U.S. in March 2006. Medtronic said that in bench testing, the Xcelerant Hydro Delivery System “was shown to generate 68 times less friction than the previous delivery system, which does not have the hydrophilic coating. Hydrophilic means “affinity for water;” because water is a major component of blood, the hydrophilic coating is designed to ease the delivery system’s passage through the artery. The Xcelerant Hydro Delivery System features an integrated sheath tapered on both ends, designed to facilitate insertion and retraction of the entire delivery catheter by minimizing the time that the surface area of the sheath is in contact with the artery wall.
Medtronic also reported FDA clearance of the Reveal DX and Reveal XT,new Insertable Cardiac Monitors (ICMs) that offer diagnostic and monitoring insights to cardiologists managing their patients with syncope or abnormal heart rhythms, including ventricular tachyarrhythmias (VT), fast ventricular tachyarrhythmias (FVT), bradyarrhythmias and asystole. The Reveal devices expand on the cardiac monitoring foundation Medtronic says it began more than 10 years ago with the Reveal and Reveal Plus Insertable Loop Recordsrs. The Reveal DX will be commercially available in the U.S. next week; the Reveal XT will follow. The Reveal DX continuously monitors the heart’s electrical activity in order to help physicians diagnose whether or not symptoms such as fainting, dizziness and unexplained seizure-like episodes have a cardiovascular cause. Causes of syncope can be heart rhythm disturbances or abnormalities in the structure of the heart. Syncope can lead to serious injury or can be a precursor to sudden cardiac death. About 1.5 million people worldwide suffer from unexplained syncope. In almost 10% of patients, syncope has a cardiac cause; in 50%, a non-cardiac cause; and in 40% the cause is unknown. Syncope is difficult to diagnose as syncopal episodes are often too infrequent and unpredictable for detection with conventional monitoring techniques. Placed under the skin of the chest area using local anesthesia during a simple outpatient procedure, the Reveal DX monitor records important cardiac rhythm data, which may help a physician to diagnose the patient so the appropriate treatment can be undertaken. The device weighs 15 grams and is about the size of a memory stick. Unlike a pacemaker or implantable cardioverter-defibrillator, there are no leads that extend from the device into the heart’s chambers.
• Olympus America (Center Valley, Pennsylvania) said that the FDA has cleared the Olympus PK7300 automated microplate system for use in the U.S. The FDA has also licensed blood grouping and phenotyping reagents specifically formulated and manufactured exclusively for use on the PK7300 instrument. Designed for blood donor centers, the system will offer the performance that has made Olympus the leader in the field. Olympus systems test more than 90% of the North American blood supply. The newest member of the PK7000 series utilizes the same proven technology, agglutination in the Olympus microtiter plates, as its predecessors — the Olympus PK7100 and PK7200 systems. The PK7300 system features enhanced process control, increased throughput and reduced maintenance. Olympus makes high-throughput automated blood bank instruments.
• PLC Systems (Franklin, Massachusetts) reported that it has discussed the results of its pilot safety study of the RenalGuard system and therapy with the FDA. Based upon the positive safety data already collected in the pilot study and its discussions with FDA, PLC has stopped enrolling new patients in the pilot study and will submit a request to transition into a new pivotal trial protocol. The trial is expected to demonstrate that RenalGuard is effective in reducing the incidence of contrast-induced nephropathy (CIN) in at-risk patients undergoing cardiovascular imaging procedures. PLC Systems specializes in technologies for the cardiac and vascular markets.
• The Sorin Group (Milan, Italy) reported the first commercial implant of the Mitroflow aortic pericardial heart valve in the U.S. Introduced in Europe in 1982, the Mitroflow valve is a testament to the company’s experience with bovine pericardium, from tissue harvesting to proprietary design solutions and high technology processes. Because the pericardium is mounted on the outside of the stent, it allows for maximum valve opening and optimum blood flow. The Mitroflow bioprosthesis offers surgeons the option, based on patient anatomy, of a supra-annular or an intra-annular valve placement designed to reduce the risk of patient-prosthesis mismatch and enhance hemodynamic performance. The sewing cuff design has shown that the valve is easy to suture, conformable to the native annulus and adaptable to difficult anatomies.
• St. Jude Medical (St. Paul, Minnesota) reported FDA and CE Mark approvals of the Durata defibrillation lead, the company's newest high voltage lead. Durata features a soft silicone tip with a larger surface area and a slightly-curved right ventricle (RV) shock coil, intended to enhance ease of use and handling for implanting physicians. The Durata lead also incorporates Optim insulation, a hybrid insulation material unique to St. Jude Medical and created specifically for cardiac leads. Optim insulation blends the biostability and flexibility of silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane to provide increased durability, along with the flexibility and handling characteristics that facilitate device implantation.
• The first fully automated ablation system supporting an open-loop irrigated catheter using remote navigation with the Niobe magnetic navigation system, designed by Stereotaxis (St. Louis) and the Carto RMT system by Biosense Webster (Diamond Bar, California), has received FDA approval. The system uses the Navistar RMT Thermocool Irrigated Tip Catheter and the Coolflow Pump from Biosense Webster, with the Stockert RF Generator. The catheter incorporates small irrigation holes at the tip to provide cooling during RF ablation. The addition of the Niobe magnetic system and the Carto RMT system provides electrophysiologists with accurate 3-D mapping, targeting and remote navigation the companies said. The first fully automated ablation system supporting an open-loop irrigated catheter using remote navigation with the Niobe magnetic navigation system, designed by Stereotaxis and the Carto RMT system by Biosense Webster, has received FDA approval. The system uses the Navistar RMT Thermocool Irrigated Tip Catheter and the Coolflow Pump from Biosense Webster, with the Stockert RF Generator. The catheter incorporates small irrigation holes at the tip to provide cooling during RF ablation. The addition of the Niobe magnetic system and the Carto RMT system provides electrophysiologists with accurate 3-D mapping, targeting and remote navigation the companies said.
• Theregen (San Francisco) has completed enrollment of its 15-patient Phase I safety trial for the Anginera epicardial patch on patients undergoing coronary arterial bypass graft (CABG) surgery. The company said it intends to treat patients suffering from cardiac dysfunction who are undergoing surgery for a variety of reasons, including CAD and ischemia, heart valve disease or septal defects. It said that in each of these populations, a portion of the heart is beating poorly, and Anginera has demonstrated an ability to improve both perfusion and regional ventricular wall function. In patients with ischemia and prior myocardial infarction or heart attack, this treatment may limit the area of heart muscle damage by providing better local perfusion. It may also awaken “hibernating myocardium” to improve ventricular wall function, and may not only improve function in the short term, but may prevent the progressive deterioration of function that leads to increasing Heart Failure. Theregen is “re-purposing” an existing FDA-approved device for cardiac applications.
• ThromboVision (Houston) said it has initiated clinical trials of the ThromboGuide (T-Guide) platelet function monitor. The T-Guide consists of a disposable test kit and a point-of-care base unit. The system will help physicians improve their cardiac patients’ lives by individualizing antiplatelet therapy that they use to prevent heart attacks, strokes and stent occlusions. ThromboVision has licensed the patented technology developed by scientists affiliated with the Utah Artificial Heart Institute (Salt Lake City), Brigham Young University (Provo, Utah) and the University of Utah (Salt Lake City). ThromboVision is a developer of biomedical diagnostics.
• Ymed (San Diego) said it has completed its first U.S. cases with its VascuTrak II PTA dilation catheter. The catheter is a 5 Fr compatible, single-operator, rapid exchange system, Ymed said. It is designed and indicated for vascular intervention of a range of peripheral arteries, including the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. Ymed makes products for vascular intervention, providing less-invasive therapy for a range of circulatory diseases.