Senior management at CryoCath Technologies (Montreal, Quebec) was elated over the result of an FDA advisory panel meeting last month, despite a list of conditions the company must now address. The agency's Circulatory System Devices Panel recommended approval of the company's premarket approval (PMA) application for the Freezor cardiac cryoablation catheter. The panel voted 8-3 in giving its thumbs-up to the device, specifically to treat atrioventricular node re-entry tachycardia (AVNRT), which is the most commonly ablated cardiac arrhythmia. But CryoCath must satisfy four conditions for approval. The conditions are benign as far as getting the product to market, said president and CEO Steven Arless. "We expect significant pent-up demand for the system from cardiologists in the U.S.," he said. "Upon ultimate FDA approval, Freezor will become a profitable and solid addition to our growing U.S. base of operations as we continue to build a global franchise in cardiac ablation."

The panel's first condition is to modify the device's labeling to include cryoglobuleanemia as a contraindication, a rare side effect of the treatment where frozen protein coagulates. Secondly, the company must eliminate cryomapping as an application for the procedure. The panel also included a condition that a formal training program be developed for the users, as well as conducting post-market surveillance to track the incidence of a rare adverse event: complete heart block following the procedure. The FDA had said this adverse event could happen between 1% and 4% of the time with existing technology. However, Jean-Pierre Desmaraise, CryoCath's vice president of scientific affairs, said that "the Freezor has not resulted in a single case of heart block in more than 600 procedures performed in Europe and elsewhere."

An approval from the FDA could come as early as June, Arless said, and would fall in line with the company's goal of introducing the device in the U.S. in the second half of this year. As an historical note, he noted that approval of the device would make CryoCath the first Canadian firm to receive a PMA approval from the FDA for a therapeutic medical device.

AVNRT represents about two-thirds of the current ablations performed, and the company projects between 60,000 to 70,000 to be performed annually in the U.S., Arless noted. The company expects this particular procedure to grow by two to three times the current number in the coming year, he added. The catheter is a single-use minimally invasive cryoblation device designed to create focal lesions to treat high-risk arrhythmias near the AV node where precision is critically important. The Freezor, upon approval, will be the second device the company has launched in the U.S., Arless said.

The panel's recommendation came after lengthy and sometimes heated debate over safety and effectiveness. When discussing the 103 procedures performed in the U.S. as part of the clinical trial, the chair of the panel expressed his doubts. "There's a chance you take when you start a clinical trial. You roll the dice and sometimes you win, but this time they didn't," said Warren Laskey, MD, chief of interventional cardiovascular medicine at the National Naval Medical Center (Bethesda, Maryland). Laskey and two or three of the other panelists suggested that the trial conclusions were not valid because of its relatively limited enrollment. Other panel members disagreed, stating that the device, while not proven to be better, was at least as effective as the current treatment using radio frequency. "I feel the device is reasonably safe and will offer a different approach or tool to treating a difficult problem," said Francis Gilliam III, MD, clinical cardiac electrophysiologist with Virginia Cardiovascular Specialists (Richmond, Virginia).

CryoCath introduced its SurgiFrost surgical tool in 2002 to ablate cardiac arrhythmias. Arless said that the company would seek several follow-on indications for the catheter in the coming years. "We'll conduct several post-market studies on a smaller scale to seek additional approvals for other indications," he said. Gaining FDA approval also will speed the approval process along for the device in Japan, Arless said, adding that the Japanese market is the second-largest in the world, following the U.S.

The FDA is not bound by a panel's recommendation but usually follows the advice.

Elsewhere in the product pipeline:

Abiomed (Danvers, Massachusetts) said that the FDA has completed its review of the company's premarket approval supplement requesting approval of a new drive and control system for its BVS product line. The FDA has determined that the supplement is approvable, subject to successful inspection of the manufacturing facilities of Abiomed's contractor for electronics manufacturing. The new AB5000 Circulatory Support System console will drive one or two BVS 5000 blood pumps, either in the hospital or for transport of patients between hospitals. Incorporating an electronic interface, the AB5000 is designed to improve the convenience and ease of use of the current BVS blood pump and to serve as a common platform for future heart-assist blood pumps currently under development at Abiomed.

Acusphere (Watertown, Massachusetts) has initiated a Phase III clinical study of AI-700, an ultrasound contrast agent designed for detecting coronary artery disease in patients with ischemic heart disease. The Phase III program began recently with a pilot study to ensure that the clinical sites are fully familiarized with AI-700 imaging techniques. Two concurrent international pivotal trials are scheduled to follow this pilot trial.

Boston Scientific (Natick, Massachusetts) said it has started its TAXUS V clinical trial, which plans to evaluate more than 1,100 patients at up to 70 sites in the U.S. The first patients were enrolled earlier this month in the de novo lesion portion of the trial. The TAXUS V trial is an extension of the TAXUS IV study designed to assess the safety and efficacy of a slow-release formulation of paclitaxel to support regulatory filings for U.S. product commercialization. TAXUS V will study a higher-risk patient population than TAXUS IV, including patients with smaller vessels as well as those with longer lesions requiring overlapping stents. Boston Scientific also said that it has submitted the second module of its premarket approval application for its Taxus paclitaxel-eluting coronary stent system to the FDA. The company submitted the first module in February and plans to submit the fifth and final module in June. Boston Sci launched the Taxus drug-eluting stent in Europe and other international markets in February. It anticipates launching the product in the U.S. late this year. The TAXUS clinical program is a series of studies designed to collect data on Boston Sci's polymer-based, paclitaxel-eluting stent technology for reducing coronary restenosis. The TAXUS IV trial has completed enrollment and nine-month follow-up is under way. TAXUS VI is studying patients with complex coronary artery disease and has completed enrollment. Boston Scientific also has initiated a transitional registry program (WISDOM) in a number of countries as part of a limited commercial launch of the Taxus system. A European post-market registry (Milestone II) is expected to begin soon following the recent European commercialization of the Taxus product. Taxus uses the Express2 coronary stent system as its platform. The FDA has granted the Taxus stent expedited review, possibly fast-tracking it to an earlier-than-expected approval. In its notification letter to the company, the FDA stated that the Taxus product might represent "a breakthrough technology" offering an alternative to current FDA-approved technologies for treating coronary artery disease. "This designation represents further progress for our drug-eluting stent program," said President and CEO Jim Tobin. He added that the company's Taxus launch in Europe and other international markets is going well and that it is "continuing to work toward a U.S. launch late this year."

Cardima (Fremont, California) said that its premarket approval application for the Revelation Tx will be reviewed during a May 29 meeting of the FDA Circulatory System Devices Panel. The company further reported that its manufacturing facility was recently inspected as part of the ongoing FDA marketing approval process and the company has subsequently received a letter certifying compliance with FDA manufacturing standards. Cardima developed the Revelation Tx linear ablation microcatheter system as a minimally invasive, single-use product that may have the potential for curing AF. Cardima said it believes the Revelation Tx to be the first device to treat AF that has been submitted on a premarket approval application to the FDA. Cardima submitted the PMA to the FDA last September and was granted expedited review status by the FDA in November. That application is still pending before the FDA. The company said clinical trial data from the Revelation Tx microcatheter demonstrated safety and promising efficacy.

CardioVations (Somerville, New Jersey), a division of Ethicon (also Somerville), introduced the Myolift Heart Retractor and the Flexsite Heart Stabilizer, instruments that help position the heart and stabilize the coronary artery during cardiac surgery. The devices can be used together to expose coronary vessels and permit precise placement of stabilization "feet" to hold the coronary artery in place, allowing cardiac surgeons to bypass the blocked artery without resorting to the traditional method of stopping the heart and employing the heart/lung machine. The Flexsite stabilizer device consists of malleable vacuum and compression feet that can also be contoured to enable positioning on all attachment, arm alignment and precise positioning. The Myolift heart retraction device is made of a soft, compliant suction cup, which conforms to the heart. This is mounted to a comformable pseudoelastic arm that can be used to position the suction cup and heart as desired.

Coalescent Surgical (Sunnyvale, California) said that the first sutureless mitral annuloplasty repair was performed last month by W. Randolph Chitwood Jr., MD, chief of cardiothoracic surgery at the Brody School of Medicine at East Carolina University (Greenville, North Carolina). Chitwood used Coalescent's U-CLIP device to replace conventional sutures and complete the robotic-assisted mitral valve repair in record time, the company said. Coalescent said many experts believe that a minimally invasive approach will expand the indication for mitral valve repair to a much larger group of patients who are presently unlikely candidates for conventional, invasive mitral valve operations due to the traditional length of cardiopulmonary bypass time.

Cybernet Medical (Ann Arbor, Michigan) said that its MedStar data transmission device is being used in a pilot study of congestive heart failure (CHF) patients in Geneva County, Alabama. The six-month study is evaluating the effectiveness of monitoring daily weight and blood pressure readings for patients diagnosed with CHF or with hypertension that may lead to CHF. The program is using the MedStar transmission device to capture and forward physiological data to the home health division of the Geneva County Health Department in real time, enabling healthcare providers to take corrective action for those patients experiencing changes in blood pressure or weight readings. Twenty patients with CHF or hypertension that may lead to CHF are participating in the pilot study, with the majority having been hospitalized at least once in the last 12 months. Each patient is using the hand-held MedStar data transmission device to capture physiological data from connected measurement tools, such as blood pressure cuffs and weight scales. The data is transferred via standard telephone lines to a collection server, where it is checked daily against parameters determined by the patient's caregiver.

Endologix (Irvine, California) said it enrolled the 190th patient in the pivotal trial of its PowerLink System, a minimally invasive treatment for abdominal aortic aneurysms (AAA). The company plans to use the data from the study to move forward with the preparation and filing of its premarket approval application for FDA approval of the PowerLink System. Clinical results on the first 118 patients enrolled in the PowerLink System pivotal trial were published in the Journal of Vascular Surgery in December 2002. The journal article's authors reported the device "appears to be safe and effectively protects patients from AAA rupture over the short-to-medium term."

ev3 (Minneapolis, Minnesota) introduced Nitrex Nitinol Guidewires offering a streamlined guidewire product line specifically for peripheral interventional procedures. Nitrex Guidewires will replace ev3's Ultra-Select and FlexFinder Nitinol Guidewire brands. Nitrex Nitinol Guidewires are constructed of a solid nitinol core from proximal to distal tip, designed for maximum kink resistance and atraumatic navigation during challenging interventional cases. The new guidewire is enhanced to optimize general access, crossing and device delivery.

Guidant (Indianapolis, Indiana) reported the first U.S. implant in its latest heart failure study, DECREASE HF (Device Evaluation of Contak Renewal 2 and Easytrak 2 Assessment of Safety and Effectiveness in Heart Failure). The study is designed to demonstrate the safety and effectiveness of the flexible pacing modes offered in Guidant's newest heart failure cardiac resynchronization therapy defibrillator, currently available in Europe. The study will compare the current standard for delivering cardiac resynchronization therapy in which the right and left ventricles are paced simultaneously. Two additional programming options include resynchronization therapy with a left ventricular offset in which the ventricles are paced independently and a mode in which only the left ventricle is paced. The first implant of Guidant's Renewal 2/Easytrak 2 system was performed by Dr. Michael Giudici at Genesis Medical Center (Davenport, Iowa). The DECREASE HF trial is a randomized study currently being conducted at sites across the U.S. Guidant also launched the Multi-link Penta Coronary Stent System for the treatment of coronary artery disease in Japan. The Multi-link Penta Stent System registry, involving 200 patients with de novo native coronary artery lesions, demonstrated a 17.5% binary restenosis rate, results that the company said were particularly impressive because they were achieved in lesions that were long and complex. The Multi-link Penta Stent System features Access-Link NK technology, allowing the stent to be flexible enough to be maneuvered through a patient's vessels while still retaining the strength needed to prop open a previously blocked artery.

HemoSense's (Milpitas, California) INRatio Prothrombin Time (PT) Monitoring System is being released for sale in the U.S. for patient self-testing at home and for use by medical professionals. INRatio tests and records the clotting time of blood via PT testing, which is the key blood test used for monitoring patients taking oral anticoagulants such as Coumadin. The Centers for Medicare & Medicaid Services (CMS) recently approved reimbursement for patients with mechanical heart valves, enabling greater access to PT self-testing at home. Private insurance companies are expected to reimburse as well. According to CMS, there are more than 400,000 patients in the U.S. who have mechanical valves and will be on life-long anticoagulation therapy. The INRatio system features real-time, on-board quality controls that ensure the reliability of every test and eliminate the need for liquid controls and their associated cost. INRatio is based on HemoSense's electrochemical detection technology, which combines classical electrochemistry with modern sensor technologies. It said these enabling technologies eliminate the need for the complex and costly optical detection systems found in other devices.

Immersion (San Jose, California) reported two agreements with Medtronic (Minneapolis, Minnesota). These agreements define and fund development projects and provide licensing rights for use of Immersion's intellectual property related to medical simulation for the training and education of healthcare professionals. The agreements allow the companies to develop, use and distribute advanced medical training simulators that provide tools necessary to reproduce minimally invasive medical procedures for the diagnosis and treatment of cardiovascular diseases. Under the first agreement, Immersion's engineers will work with Medtronic to develop and incorporate the company's simulation technology into advanced simulation systems for use in future cardiovascular education and training. The second agreement grants Medtronic a license to use and distribute these new technologies.

MacroPore Biosurgery (Frankfurt, Germany/ San Diego, California) said U.S. patent No. 6,531,146 has been issued for the company's bioresorbable thin film, SurgiWrap. The U.S. Patent and Trademark Office has allowed all of the claims in the patent application which include claims directed to postsurgical scar-tissue reduction throughout the body and smooth-surfaced barrier maintenance between the healing postsurgical site and the adjacent surrounding tissue. The parent application for the issued patent was originally filed Oct. 3, 2000. The patent will expire in 2021. In Europe, SurgiWrap has received CE mark approval to prevent postsurgical adhesions in cardiovascular, general, spinal and obstetric surgeries. In the U.S., it is approved for soft tissue support and reinforcement, and for adhesion prevention in specific ENT (ear, nose and throat) procedures.

Nanogen (San Diego, California) said it has commercially released the first multiplex Analyte Specific Reagent (ASR), designed for the detection of Factor V Leiden and Factor II prothrombin gene mutations associated with cardiovascular disease and the pathology of thrombosis. The Factor V/ Factor II Prothrombin ASR consists of reagents, controls and analysis of the G1691A mutation on the Factor V (Leiden) gene and the G20210A mutation on the prothrombin gene. High-complexity CLIA-certified laboratories may use the reagents to create and validate laboratory-developed tests for detection of these mutations. Mutations in the Factor V gene (Factor V Leiden) and Factor II gene (Factor II prothrombin) are the most common causes of hereditary blood coagulation disorders that can lead to cardiovascular disease. The Factor V Leiden and Factor II prothrombin mutations are present in 3% to 7% of the population in the U.S. and 2% to 3% of the population in Europe. Carriers of the Factor II mutation have a threefold to eightfold increased risk for blood clot formation, and the risk is significantly greater in those who also carry the Factor V Leiden mutation.

Neoprobe (Dublin, Ohio) received notification from the U.S. Patent and Trademark Office of the allowance of a second patent covering the products of its Cardiosonix subsidiary. The patent covers key aspects of the ADBF technology as well as innovations and enhancements to the Quantix family of products for the measurement of blood in a variety of clinical applications that also are protected by U.S. patent No. 6,503,205. Cardiosonix is in the early stages of commercializing the Quantix family of blood flow measurement products. Its products are for use by cardiovascular surgeons, neurosurgeons and critical care physicians.

NMT Medical (Boston, Massachusetts) reported receiving conditional approval from the FDA for its pivotal clinical trial to evaluate the effectiveness of transcatheter closure of a common cardiac defect using the company's StarFlex cardiac septal repair implant, compared to best medical therapy. The cardiac defect being evaluated is called a patent foramen ovale (PFO) and, under certain conditions, acts like a flap valve between the right and left atria of the heart. The PFO may allow embolic material in the venous circulation to pass, unfiltered by the lungs, to the arterial circulation where it can then travel to an artery in the brain and potentially cause a stroke or TIA (transient ischemic attack). NMT's clinical study, named CLOSURE 1, is designed to evaluate the StarFlex implant's effectiveness in preventing recurrent stroke and TIA in patients after their initial event. The study is expected to enroll 1,600 patients, with half receiving a StarFlex implant, and half receiving traditional medical therapy. Follow-up will measure recurrent events over a period of two years. More than 80 stroke and interventional cardiology centers in the U.S. have committed to participation in this study. Data management and analysis will be performed by the Harvard Clinical Research Institute (also Boston). The procedure to implant StarFlex usually lasts about 30 to 45 minutes and is typically conducted in the cardiac catheterization lab. StarFlex is designed to close the defect with native tissue growing over the implant in about six months. Patients can return to normal activity soon after the procedure. The StarFlex is an advanced design implant, which offers advantages in terms of being able to automatically adjust to variations in PFO and atrial septal anatomy in patients. StarFlex, a third-generation design, is commercially available in Europe.

Novoste (Norcross, Georgia) received FDA approval for a supplement to its investigational device exemption that will permit patient enrollment in the modified version of the BRAVO (Beta Radiation for treatment of Arterial-Venous graft Outflow) protocol. BRAVO is a randomized, multi-center, placebo-controlled trial investigating the efficacy of the Novoste Corona System to treat venous outflow stenosis in arterial-venous dialysis grafts. About 215 patients will be enrolled at more than 30 centers in North America and Europe. The approved modifications allow physicians to treat patients with thrombosed grafts, which represent a majority of the potential patients, and change the primary endpoint of the trial to be a clinical success, primary patency (the absence of reintervention), at three months, compared to the previous endpoint of successful measured dialysis flow at six months. In addition, the approved number of patients for the trial has been reduced from 230 to 215.

OmniSonics Medical Technologies (Wilmington, Massachusetts), developer of products based on the OmniWave Technology platform to treat vascular occlusive disease, said that the latest data on its Resolution System was presented at the Society of Interventional Radiology's 28th annual scientific meeting in Salt Lake City, Utah. Gary Siskin, MD, of Albany Medical Center, presented initial results from a clinical study of the Resolution System's ability to clear the thrombus from synthetic hemodialysis access grafts. John Smikahl, PhD, presented a poster abstract titled "Alteplase Stability and Bioactivity Following Applied Low-Power Transverse Cavitational Ultrasonic Energy." Smikahl presented new research on the effects of cavitation on the stability and bioactivity of a lytic drug, tPA, which is sometimes used to break up blood clots.

Orbus Medical Technologies (Fort Lauderdale, Florida) said that Michael Kutryk, MD, PhD, an interventional cardiologist at St. Michael's Hospital (Toronto, Ontario), presented his group's latest results on circulating endothelial progenitor cell (EPC) capture technology for improved blood compatibility and biocompatibility of cardiology stents and vascular grafts at the International Symposium on Endovascular Therapy and at the Local Drug Delivery Meeting and Cardiovascular Course on Radiation and Molecular Strategies in January. The EPC capture technology, which involves the immobilization of antibodies that capture EPCs on to blood contacting device surfaces, was developed in collaboration with Orbus. Laboratory results of antibody treated stainless steel and expanded polytetrafluoroethylene surfaces were shown exhibiting an enhanced rate and quantity of EPC binding vs. untreated controls when exposed to isolated human leukocytes and whole blood. At 48 hours, treated stainless-steel Orbus coronary R stents showed a confluent monolayer of endothelium in contrast to the untreated control stent samples which showed evidence of thrombus, disorganized fibrin matrix and discontinuously covering the stent struts. Also presented were early results from serial porcine coronary implants out to 28 days of R stents treated with immobilized antibodies directed toward EPCs. Initial histological examination of the treated 28-day porcine coronary explants showed a marked reduction of organized thrombus and neointimal thickening of the vessel when compared to untreated stainless-steel control stents, the company said.

Quinton Cardiology Systems (Bothell, Washington) has started shipping the new Atria 3000 ECG under the Burdick brand name. The compact, easy-to-use system is designed primarily for use in physicians' practices. This electrocardiograph is the first in a series of new products and upgrades to the Burdick ECG product line. The Burdick Atria 3000 benefits physicians' offices with extensive clinical capabilities in a compact package. The new model records and stores high-quality 12-channel ECG tracings and comes standard with advanced features that improve accuracy. A variety of upgrade options are available, including interpretation and expandable internal storage.

Rafael Medical Technologies (Caesarea, Israel) reported the start of clinical trials evaluating the mechanical aspects and safety of its SafeFlo retrievable vena cava filter for the prevention of pulmonary embolism, and the VascuGrasp, its accompanying retrieval system. In the trial, up to 30 patients at risk of developing pulmonary embolism and presenting indications for vena cava filter placement will undergo implantation of the SafeFlo filter. The company said initial implantations have provided "very encouraging results." Four patients with documented venous thromboembolism and under anticoagulation therapy were implanted with the filter. Three patients received the filter with the option of removal at a later date. On the 22nd day, post-implantation one patient underwent successful retrieval using the VascuGrasp Retrieval System. In the remaining two patients the filters were left in due to continuing risk from documented deep vein thrombosis. The IVC was patent in all patients, with no filter migration or vessel damage detected.

St. Jude Medical (St. Paul, Minnesota) reported the first implant of its new Riata single-coil defibrillation lead. The first implant of the Riata single-coil defibrillation lead was performed in Feburary at Queen Mary Hospital in Hong Kong by Dr. Chu-Pak Lau. The implantation proceeded normally, and the 67-year-old female patient is doing well, the company said. The Riata single-coil defibrillation lead along with the St. Jude Medical Epic HF ICD for cardiac resynchronization therapy, the Epic DR/VR ICDs, and the company's product line of bradycardia devices were featured in St. Jude's exhibit at the 12th World Congress on Cardiac Pacing and Electrophysiology in Hong Kong last month. The single-coil version of the Riata lead has received CE marking and has been submitted to the FDA for approval. Initially released in 2002, the Riata defibrillation lead was previously available in only a dual-coil model.

Stereotaxis (St. Louis, Missouri) reported that the Baptist Heart Institute at Central Baptist Hospital (Lexington, Kentucky) has performed the first robotic catheterization procedure using the Niobe Magnetic Navigation System, a recently FDA-approved technology that is used to navigate medical devices, such as catheters and guidewires, through the cardiovascular system to designated target sites in the heart and coronary vasculature. The system is based on Stereotaxis' innovations using computer-controlled magnets, positioned external to the body, to steer magnetically enabled catheters and guidewires throughout the cardiovascular system. The system is integrated with Siemens Medical Solutions' (Malvern, Pennsylvania) Axiom Artis dFC digital fluoroscopy system, which is used to visualize the devices as they are navigated. The image-guided, computerized, magnetic navigation and control system is aimed at addressing problems associated with manual catheter steering and positioning. This approach allows for 360-degree rotation of the catheter and is expected to increase the potential for greater precision. Advanced fluoroscopic technology integrated with distal tip catheter control allows the clinicians to better leverage the imaging information to ensure the catheter is positioned properly, without trial and error. The system fits into a standard cath lab room.

Thoratec (Pleasanton, California) reported that the Medicare Coverage Advisory Committee (MCAC) voted favorably last month on two questions presented to it by the Centers for Medicare & Medicaid Services (CMS) regarding Medicare coverage for the use of Left Ventricular Assist Devices (LVADs) for destination therapy, with the company's HeartMate VE being the only such device currently FDA-approved for that application. The HeartMate was judged to be superior to drugs and offered quality of life improvements to patients with severe heart failure who are not eligible for a transplant, according to the advisory panel, which makes coverage recommendations to the CMS. "The quality of the evidence was adequate to draw conclusions about the net health outcomes in Medicare beneficiaries comparable to patients enrolled in the REMATCH trial," the panel said. The majority of panel members voted that LVADs provide a "substantially more effective" net patient outcome, a ranking second only to "breakthrough technology" out of a list of eight possible outcomes. MCAC's recommendations are advisory only, and CMS has the final decision regarding national coverage policies. However, Thoratec said it believed that CMS will issue a national coverage decision, hopefully within 90 days, and during a conference call the company projected a decision coming "possibly even sooner." Thoratec received FDA clearance last November to market the HeartMate VE LVAS (left ventricular assist system) for destination therapy, or permanent support for end-stage heart failure patients who are not eligible for heart transplants, thus marking the first time a VAD has been approved to provide permanent support for these patients. Currently, Medicare pays about $51,000 of the $211,000 mean cost (median cost of $140,000) of implantation including hospital and doctor fees to assist the hearts of patients waiting for a transplant, and it is assumed that the destination therapy application could initially be covered under a similar level since they both would be in the same DRG (DRG 525) which covers VADs. Assuming that CMS agrees to cover the destination therapy indication, Keith Grossman, president and chief executive officer, said the company's next step is to work with the agency "to try to figure out how to pay it in a way that better reflects the true cost of the therapy."

WorldHeart (Ottawa, Ontario) has made a submission to Health Canada requesting approval for enhancements to its Novacor LVAS (left ventricular assist system). The refinements are intended primarily to enhance recipients' quality of life by having a quieter device and smaller, lighter, longer-lasting battery packs. These enhancements, which are commercially available in Europe and under review by the FDA, are the result of the evolution of extensive clinical experience with the Novacor LVAS. Improvements that will directly benefit recipients, according to the company, include quieter pump operation, new battery packs that are 40% lighter and operate for 60% longer and a smaller, quieter battery charger.