The first implantation of an AbioCor Replacement Heart since last May was reported in early March by the device's manufacturer, Abiomed (Danvers, Massachusetts). Abiomed said the implantation, the 12th in a clinical trial that began in July 2001, occurred Feb. 20 at the Texas Heart Institute at St. Luke's Episcopal Hospital (Houston, Texas). As is Abiomed's policy, no patient information was released. The company said additional information would be made available when the Texas Heart Institute clinical team and the patient's family "deem it is appropriate."
The AbioCor device is the subject of a clinical trial being conducted under an investigational device exemption from the FDA. Abiomed has reported its intention to seek initial FDA market approval this year for the AbioCor to treat a defined subset of irreversible end-stage heart failure patients under a humanitarian device exemption. The FDA-established criteria for candidates for the AbioCor clinical trial are that they must suffer from biventricular heart failure, be ineligible for heart transplantation, unable to be helped by any other available therapy and have a high probability of dying in less than 30 days.
Abiomed has FDA approval to implant the replacement heart in 15 patients in the current trial. Ed Berger, vice president of strategic policy and planning at Abiomed, had said during a company conference call in mid-February that "the next implant could happen at any time." Thus far, implantations have taken place at Jewish Hospital (Louisville, Kentucky), St. Luke's, UCLA Medical Center (Westwood, California) and MCP Hahnemann University Hospital (Philadelphia, Pennsylvania). In the February conference call, Berger noted that Beth Israel Deaconess Medical Center (Boston, Massachusetts) had been added to the clinical site list for possible future implantation of the AbioCor device. Three European sites also have been identified, but no implantations have taken place in any of them to date.
In addition to the AbioCor Replacement Heart, Abiomed has developed the AB5000 Biventricular Support System and the AB5000 Circulatory Support System. The FDA-approved AB5000 is categorized by the company as a ventricular assist device (VAD) that is deployed outside the body rather than implanted, as are most VADs. At the time FDA approval was reported last fall, Berger said the AB5000 is intended for short-term support of a failing heart rather than as a bridge to transplant or for end-stage support.
Elsewhere in the product pipeline:
Access CardioSystems (Concord, Massachusetts) unveiled its Biphasic WaveControl clinical study results at the American College of Cardiology (ACC; Bethesda, Maryland) scientific sessions last month in New Orleans, Louisiana. The study demonstrated 100% first shock efficacy for Biphasic WaveControl, Access CardioSystems' proprietary biphasic waveform, used in the AccessAED and AccessALS automated external defibrillators. The study was conducted on 60 patients at Johns Hopkins University Hospital (Baltimore, Maryland), St. Elizabeth's Medical Center (Boston, Massachusetts) and the University of Rome (Rome, Italy). The study was performed on patients undergoing routine arrhythmia testing or evaluation of an implantable defibrillator. Results of the study showed that 100% of the patients were successfully defibrillated by the AccessAED on the first shock at the device's lowest energy setting; 200 Joules. No adverse effects were observed after defibrillation with the AccessAED.
Aventis (Bridgewater, New Jersey) reported that the ORIGIN (Outcome Reduction with Initial Glargine Intervention) trial has entered the active recruitment phase and has enrolled more than 400 patients to date. The trial is the first major clinical study to help determine whether the use of Lantus (insulin glargine [rDNA origin] injection) a 24-hour basal insulin analogue can reduce the incidence of cardiovascular events in people with early diabetes or pre-diabetes who are at high risk for cardiovascular disease. The five-year trial will include 10,000 participants from 600 sites in more than 35 countries. ORIGIN will evaluate the effectiveness of Lantus compared with standard management of blood glucose elevations in reducing cardiovascular morbidity and mortality in people with dysglycemia.
Biotronik (Lake Oswego, Oregon) reported the market release and subsequent nationwide implantations of its Lexos implantable cardiac defibrillator, the only device available in a small, physiologic shape that provides completely automated, wireless early detection of cardiac events without patient action. The company said the Lexos ICD offers four distinct advantages: a small, thin profile designed to increase patient comfort and reduce incision size; industry-proven capacitors that deliver consistent charge times throughout the life of the device; up to six years longevity that provides fewer device replacements and more cost-effective therapy; and Biotronik's Home Monitoring system. Events are automatically transmitted from the ICD to the Home Monitoring web site, which provides access to patient and device data anytime, from anywhere.
Boston Scientific (Natick, Massachusetts) reported the start of enrollment in the ARRIVE registry program, which plans to enroll 2,000 patients at about 50 centers in the U.S. It is designed to collect and analyze "real-world" safety and clinical outcomes data for the Taxus Express2 paclitaxel-eluting stent system in the treatment of patients with coronary artery disease. In cooperation with the FDA, the ARRIVE registry was been initiated prior to FDA approval of the Taxus system, and is continuing post-approval. The Taxus system received FDA approval early last month. Separately, Boston Scientific has received a license for the sale of its Carotid Wallstent Monorail Endoprosthesis in Canada. The company said it plans to launch the product to that market immediately. The Carotid Wallstent Monorail Endoprosthesis is a self-expanding stent mounted on a rapid exchange deployment system, designed to open the carotid artery and improve blood flow to the brain.
Cardiac Science (Irvine, California) reported the marketing launch of a new fourth-generation automated external defibrillator (AED) that targets sophisticated users of lifesaving equipment such as hospital personnel, medical professionals, paramedic firefighters and emergency medical technicians. The company said it anticipates shipments to international customers and distributors to begin in May, with sales in the U.S. pending FDA approval. The Powerheart AED G4 is specifically designed to provide healthcare professionals continuous cardiac monitoring capability and decision-making latitude during the emergency treatment of victims of sudden cardiac arrest. The G4 weighs only six pounds and includes patented features such as one-button operation, RescueReady technology that performs daily self-tests of batteries, electronic systems and disposable defibrillation pads as well as configurable STAR biphasic energy protocols and RhythmX detection algorithms. Cardiac Science also reported the marketing launch of the Powerheart G3-Automatic, a fully automatic portable defibrillator for use in public places and homes. The G3-Automatic is the first patented AED on the market that only requires a rescuer to listen to the device's voice prompts and attach the device to a victim of cardiac arrest. Once attached, the device detects the victim's heart rhythm, analyzes that signal using its proprietary RHYTHMx algorithm technology, and, if a life-threatening rhythm is detected, notifies the user to stand clear and delivers an electrical shock capable of restoring normal heart function. The company has begun shipments to international customers and distributors, with sales in the U.S. pending receipt of FDA 510(k) marketing clearance. The device is maintenance-free, weighs only six pounds and comes standard with a five-year replacement warranty.
Cardima (Fremont, California) reported the first clinical use, in an electrophysiology application, of its Inellitemp radio frequency (RF) energy management device in conjunction with its Revelation series microcatheter to treat atrial fibrillation (AF). Dr. Jaswinder Gill at Guy's and St. Thomas Hospital (London) performed the procedure on a patient suffering from paroxysmal AF using Cardima's Revelation Helix 2.5 STX microcatheter in conjunction with the Inellitemp. The procedure took less than 30 minutes. This ablation process normally takes a minimum of 1.5 hours to 2 hours, the company said.
CardioDynamics (San Diego, California), which offers Impedance Cardiography (ICG) technology, reported the publication of an ICG hypertension study in the February issue of Congestive Heart Failure showing a 57% blood pressure control rate in previously uncontrolled hypertensive patients in a generalist physician setting. Researchers at Harrison Memorial Hospital (Bremerton, Washington) treated resistant hypertensive patients on two anti-hypertensive medications using the BioZ and Mayo Clinic hypertension algorithm. Over a three-month period, 57% of the previously uncontrolled patients achieved blood pressure under 140/90 with the aid of ICG-guided therapy. The study's investigators concluded that their results "demonstrate superior blood pressure control using a treatment algorithm and serial hemodynamic measurements compared with clinical judgment alone in a randomized prospective study." In subjects with uncontrolled blood pressure on two antihypertensive agents, they said "ICG-guided pharmacologic decision-making resulted in a significant reduction in blood pressure and improvement in blood pressure control. ICG is a safe, effective, and cost-effective tool to assist community generalists treating uncontrolled hypertension."
Chase Medical (Richardson, Texas) said results of a study on heart failure patients who received its TRISVR (tri-saver) surgery were presented at the Society of Thoracic Surgeons meeting in San Antonio, Texas. The TRISVR procedure, a surgical alternative to treat heart failure, uses the Mannequin Endoventricular Shaping Device to resize and reshape the damaged heart close to its original form, helping the weak heart to pump more efficiently. The study, which includes 175 patients, showed an 89% survival rate in those who have been followed over a 19-month period. The study results showed the TRISVR procedure helped to significantly improve the overall pumping function of the damaged heart; improve the level of heart failure classification; and improve the heart valve function, resulting in lengthened life for patients, the company said.
CHF Solutions (Brooklyn Park, Minnesota) reported that the Minnesota Heart Failure Consortium (MHFC; Minneapolis, Minnesota), a non-profit research organization, has launched a clinical study of the company's System 100 Fluid Removal System, a mechanical pump/ultrafiltration system that removes excess fluid from fluid-overloaded patients. Called RAPID CHF (Randomized Control Trial of Ultrafiltration for Decompensated Congestive Heart Failure), the study is designed to demonstrate the efficacy of ultrafiltration vs. the best medical therapy drugs in hospitalized congestive heart failure patients with fluid overload. The RAPID CHF study is assessing several measures of clinical efficacy, including total weight loss, quality of life, level of CHF disease classification, length of hospital stay and blood chemistry changes before, during and 30 days after treatment. The RAPID CHF study is under way at six Minneapolis/St. Paul-based hospitals and will enroll 40 patients.
Digirad (San Diego, California) reported the release of its OptiCount collimator that increases the organ sensitivity of Digirad's nuclear cardiology imaging systems by an average of 15% per detector head, while maintaining the same level of reconstructed image spatial resolution. When used in conjunction with Digirad's third-generation Solidium detectors, OptiCount collimation improves organ sensitivity by at least 30% over specifications listed for some conventional competitive Anger cameras. The OptiCount product is available as an optional accessory on new solid-state gamma cameras or as an upgrade to Digirad's existing installed base of cameras.
Edwards Lifesciences (Irvine, California) said it has received FDA approval for its ThermaFix process, an advanced tissue treatment developed to mitigate calcification of tissue heart valve leaflets. The ThermaFix process was co-developed with Edwards by Prof. Alain Carpentier, chairman of the department of cardiovascular surgery at the Hopital Europeen Georges Pompidou (Paris) and inventor of Edwards' line of Perimount tissue replacement heart valves. The ThermaFix process will be featured initially on select Edwards heart valves, including the Carpentier-Edwards Perimount Magna valve.
Medtronic (Minneapolis, Minnesota) said it has received FDA approval for the first fully automated pacemaker to speed up slowly beating hearts. Enpulse is the first implantable pacemaker that does not require a doctor to regularly measure the minimum amount of energy needed to stimulate the heart to beat faster. Enpulse automatically monitors and adjusts the level of electrical impulses at regular intervals. Separately, Medtronic reported FDA approval and market introduction of a second version of its pacing lead, CapSureFix Novus. The new CapSureFix Novus Model 4076 lead is a polyurethane-insulated version of the CapSureFix Novus Model 5076, which has a silicone outer insulation. Both are slender, active-fixation leads designed to be firmly anchored in specific locations of the heart wall for the treatment of bradycardia, tachycardia and atrial fibrillation. The Model 4076 is slightly thinner than the 5076 (5.7 Fr vs. 6.1 Fr). Both use silicone to insulate inner conduction materials, both elute a steroid to reduce pacing thresholds, and both offer 10 mm tip-to-ring spacing. The newer model incorporates titanium nitride-coated electrodes.
OmniSonics Medical Technologies (Wilmington, Massachusetts) said it has been granted three U.S. patents covering its OmniWave Technology platform: U.S. patent No. 6,695,782, titled "Ultrasonic probe device with rapid attachment and detachment means," U.S. patent No. 6,695,781, titled "Ultrasonic medical device for tissue remodeling," and U.S. patent No. 6,679,873, titled "Method for using a steerable catheter device." OmniSonics also has applied for corresponding international patents to cover each of the U.S. patents. The OmniWave Technology platform forms the technical basis of the Resolution System, which is designed to resolve occlusions that occur in hemodialysis access grafts and as a result of coronary artery disease, deep vein thrombosis and peripheral artery disease.
Rubicon Medical (Salt Lake City, Utah) reported that its Rubicon Filter was showcased at the Joint Interventional Meeting (JIM; Rome, Italy) during a live broadcast of a human case. The surgery involved the successful use of the Rubicon Filter in connection with a stent procedure and was broadcast via satellite from Heart Center Siegburg (Siegburg, Germany). The surgery was performed by Dr. Eberhard Grube and Dr. Ulrich Gerckens, both of Heart Center Siegburg. The Rubicon Filter was introduced at the conference as the "next generation in embolic protection" to the more than 1,200 physicians and attendees. The Rubicon Filter is designed for use in medical procedures downstream from a blockage in a bloodstream to allow the capture and removal of dislodged embolic material. It is a guidewire-based filter that is deployed without the use of a catheter, making it smaller and easier to navigate through blood vessels. Rubicon said it believes the Rubicon Filter is the world's smallest-profile embolic filtration device.
Sono-Tek (Milton, New York) reported the first sales of its stand-alone AccuMist stent coating system, a tool designed for use in developing processes to spray coat arterial stents with polymers containing drugs that inhibit the development of scar tissue, which can lead to the recurrence of arterial blockage. AccuMist's soft, precisely targeted spray produces uniform coatings. The stand-alone system contains facilities for programming both linear movement and rotation of the stent, and an easily accessible spray area for loading and unloading, as well as a precision liquid delivery system capable of providing a wide range of flow rates.
Thermogenesis (Rancho Cordova, California) reported that Asahi Medical (Tokyo), the exclusive licensed distributor of its CryoSeal System in Japan, has completed a 70-patient clinical trial on cardiovascular, orthopedic, neurosurgery and esophageal surgery patients. The clinical trial was designed to study efficacy, safety and usefulness of the all-autologous CryoSeal Fibrin Sealant System. The company said Asahi Medical expects to submit its license application to Japan's Ministry of Health, Labor and Welfare in the first half of this year.
Toshiba America Medical Systems (Tustin, California) introduced a new version of 3-D vascular imaging technology for its Infinix i-series line of vascular X-ray systems. New 3-D fusion digital subtraction angiography (3D-FDSA) technology illustrates both intracranial vascular anomalies and detailed anatomic correlation with surrounding bone structures, to determine the best therapy for the patient. The fusion of 3D-DSA and 3-D bone images produces a high-resolution 3D-FDSA image that accurately depicts fine anatomic structures and topographic relationships, which the company said is the most detailed method available for the evaluation of vascular structures and their environment.
Trimedyne (Irvine, California) reported that the U.S. Patent and Trademark Office has allowed 17 claims of its patent application on a new Laser Balloon Catheter intended to treat mitral valve prolapse in a minimally invasive procedure. The patent should issue in a few months, the company said. While the patent application covers high intensity light, radiofrequency, microwave, electrical and ultrasound energy, the company said it believes the uniform penetration of laser energy will cause a longer lasting shrinkage effect.
Vasomedical (Westbury, New York) reported that it has been granted FDA clearance for revised labeling on all of its currently available enhanced external counterpulsation (EECP) systems. Congenital heart diseases, pacemakers, bundle branch block and significant pulmonary disease were removed from the list of contraindications. Hemorrhage and coagulopathy are now listed under one contraindication as bleeding diathesis. Significant valvular disease, previously a contraindication, was modified to a precaution, and a new precaution was added for patients at high risk of excessive fluid in their lungs. Four contraindications also were clarified and pregnancy and presence of a documented aortic aneurysm requiring surgical repair have been added to the label. The action of the EECP system, which pulses counter to the heart's beating, increases blood flow to the heart muscle, decreases the heart's workload and creates a greater oxygen supply for the heart muscle while lowering the heart's need for oxygen.
WorldHeart (Ottawa, Ontario) submitted an application to the FDA last month to start a pivotal study under the existing investigational device exemption for use of Novacor LVAS for destination therapy. A response from the FDA is anticipated about 30 days from the date of submission. Novacor LVAS has Category B status under the existing IDE that permits reimbursement by the Centers for Medicare & Medicaid Services (Baltimore, Maryland) for implants within the trial, subject to approval of WorldHeart's pivotal study design and protocol by the FDA. If approved, the trial will evaluate Novacor LVAS for destination therapy use by patients suffering from irreversible left ventricular failure who are not candidates for transplantation. The objective of the trial is to demonstrate that use of Novacor LVAS is superior to optimal medical therapy by demonstrating equivalence to Thoratec's (Pleasanton, California) HeartMate XVE LVAS, which has been approved for such use.