The traditionally deliberative FDA apparently thinks a cryotherapy system developed by CryoCath Technologies (Kirkland, Quebec), which uses extremely cold temperatures to treat diseased tissue, is a hot commodity, granting the product an approval about five months ahead of schedule, an almost unheard-of feat for the agency. The company's Freezor CryoAblation System received marketing clearance from the FDA last month and is initially indicated to treat atrioventricular node re-entry tachycardia (AVNRT), which the company said is the most prevalently ablated arrhythmia in the U.S., accounting for more than 50,000 annual procedures.

Freezor is a flexible, single-use, minimally invasive cryoablation catheter that can reach tip temperatures as low as -80 C inside a beating heart. It is specifically designed to create focal lesions to treat high-risk arrhythmias near the AV node where precision is of critical importance. Cryotherapy is thought to be able to preserve the structural integrity of tissue by selectively destroying the cellular components through intra- and inter-cellular ice formation while leaving intact the connective tissue matrix. It also shows potential to greatly minimize one of the most harmful side effects of heat-based catheter treatments thrombosis, or blood clot formation, which can lead to stroke.

"Cryoablation technology represents the first real alternative to radiofrequency (RF) catheters in the last 15 years, and we are extremely bullish on our prospects to revolutionize the treatment of arrhythmias starting with AVNRTs," said Steven Arless, president and CEO of CryoCath. "Building on our European experience and based on the positive feedback we are receiving from leading physicians in the U.S., we are confident that our aggressive marketing and sales strategies will achieve our commercial objectives which include Freezor ultimately becoming the technology of choice for AVNRT ablation procedures," he told Cardiovascular Device Update.

The Freezor approval followed surprisingly close on the heels of an 8-3 FDA advisory panel recommendation in early March of the company's PMA for the system that came attached with several conditions. The first was to modify the device's labeling to include cryoglobuleanemia as a contraindication, a rare side effect of the treatment where frozen protein coagulates. 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, an adverse event that the FDA said could happen between 1% and 4% of the time with the existing technology.

CryoCath initially was told that it must eliminate cryomapping as an application for the procedure as an integral part of the system, but it was able to remove that condition. "We worked it out with the FDA and in our instructions for use we do have cryomapping with ablation of AVNRT," Arless said. "Cryomapping is part of AVNRT; it's part of the procedure. There was nothing in the data that suggested that cryomapping is dangerous or unsafe."

Jean-Pierre Desmarais, vice president of scientific affairs, said, "The fact that we received this approval in less than the prescribed 180 day time-frame and within six weeks from the panel review meeting is a strong endorsement from the FDA of both the Freezor technology and the panel's recommendation to grant approval." Arless attributed the rapid approval to "a good ongoing working relationship with the FDA, a real solid file and a panel recommendation that was clear to the FDA."

CryoCath said it planned to make the product launch a centerpiece at this month's North American Society of Pacing and Electrophysiology (NASPE; Natick, Massachusetts) annual scientific sessions in Washington, including hosting a major symposium on cryotherapy.

Arless said the company would now seek, via a supplemental pathway, other cardiac applications for the Freezor. "We're targeting all the major arrhythmias," he said, adding that he believes cryotherapy will ultimately help his company become the No. 1 player in cardiac ablation over the next five years.

"Cryo is fundamentally a better, safer energy to use," Arless said. "If you can get it to work as effectively and as efficiently and as simply as some of the other tools, then at the end of the day the safety element of cryo will play out."

Elsewhere in the product pipeline:

Advanced Stent Technologies (AST; Pleasanton, California) received FDA approval to begin a pivotal study of its SLK-View stent and delivery system. The study, named Bifurcation Optimized with the SLK-View Stent (BOSS), will use the SLK-View stent and delivery system to provide side branch access while treating coronary bifurcation lesions. Following completion of the BOSS pivotal study and follow-up examinations, AST intends to submit the data that will be developed to file a premarket approval application to market the SLK-View stent and delivery system in the U.S. The co-principal investigators for the nationwide study will be Dr. Jeffrey Moses, chief of interventional cardiology at Lenox Hill Hospital (New York), and Dr. Maurice Buchbinder, director of the foundation for cardiovascular medicine at Scripps Memorial Hospital (La Jolla, California). The study will be conducted at up to 35 medical centers. The SLK-View stent and delivery system is commercially available in over-the-wire and rapid exchange versions in Germany, France, Austria, Italy, Greece, Cyprus, Egypt and several countries in the Asia-Pacific region, and is in registration in Canada, Brazil, Israel and elsewhere.

Bioheart (Weston, Florida) said that physicians at Mount Sinai Medical Center (New York) last month conducted the first procedure in the U.S. in which cells taken from a patient's leg were implanted in the patient's heart to treat congestive heart failure (CHF). The developmental procedure, known as autologous skeletal myoblast transplantation, is a form of cellular therapy, an entirely new approach to CHF treatment, which currently centers on medications that increase the heart's pumping ability. The research is being sponsored by Bioheart, which developed the technology for processing the harvested cells called the MyoCell procedure, for the catheter being used to implant them in the Mount Sinai study. In the Bioheart treatment strategy, muscle cells are harvested from the patient's own thigh. These cells are then treated with a proprietary process and then the myoblast cells are reinserted, via a catheter, into the patient's ventricle. The cells are delivered by means of a 7 Fr catheter through a femoral artery into the ventricle. While dead heart muscles don't regenerate, it is believed that they can provide a scaffold for the new cells to grow and return a heart to strong pumping activity. Proof of this concept has been demonstrated in the company's preclinical trials in a variety of animals. The landmark procedure at Mount Sinai was performed as part of a 15-patient trial to determine the safety and feasibility of the technique that was approved by the FDA last September. Warren Sherman, MD, associate director of Mount Sinai's cardiac cath laboratory and co-principal investigator in the clinical trial, performed the procedure. Sherman was involved in the first autologous skeletal myoblast transplants via catheter, which were done in Europe about two years ago. "The reason we take leg muscle," Sherman said, "is that leg muscle, just like other skeletal muscle in the body, has the ability to repair itself." In contrast, he said, "The heart [muscle] is highly non-regenerative."

Bristol-Myers Squibb Medical Imaging (Billerica, Massachusetts) said the results of a company-sponsored study demonstrate that regardless of race, patients with a normal stress test with Cardiolite (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection) have an excellent prognosis for cardiac-event free survival and may not require further invasive testing for heart disease. Those findings were presented at the 52nd annual scientific sessions of the American College of Cardiology in Chicago, Illinois. Cardiolite is an agent used during stress myocardial perfusion imaging (MPI) to non-invasively evaluate the heart's pumping ability and gauge the amount of blood flow to the heart muscle itself. It thus can assess whether a patient has heart disease or is at risk for a cardiac event in the future. Akinboboye and his colleagues studied 769 patients including 265 Hispanics (173 female), 268 Caucasians (119 female) and 236 African Americans (152 female) who had a normal gated perfusion study between January 1999 and December 2000. The study indicated that in patients with known or suspected coronary artery disease, a normal stress Cardiolite study is associated with a less than 1% chance that a patient will experience a "hard" cardiac event (death or heart attack) in the next 12 months.

CardioMend (Santa Barbara, California) reported the first clinical use of its product, AccuMend SL, a set of instruments designed to facilitate stentless aortic valve reconstruction using autologous pericardium. Gilles Dreyfus, MD, cardiac surgeon at the Royal Brompton and Harefield Hospitals (London), performed the operation on Feb. 14. The patient, now at home, is a 42-year-old man. Using the sizing, cutting and holding instruments designed and manufactured by CardioMend, Dreyfus excised the diseased valve and reconstructed a normal trileaflet valve with the patient's own pericardium. CardioMend recently entered into a distribution agreement with CardioLife Research (Brussels, Belgium) for the clinical introduction and marketing of AccuMend SL in Europe. CardioMend has obtained the CE mark for its products and also has FDA approval in the U.S.

CardioVations (Somerville, New Jersey), a division of Ethicon, 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 using a 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 cut, 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.

Cybernet Medical (Ann Arbor, Michigan) said it has received FDA clearance to expand the capabilities of its MedStar Disease Management Data Collection System. Used to remotely collect and transmit the physiological data of patients with chronic diseases such as asthma, hypertension and congestive heart failure (CHF), the hand-held MedStar unit now includes an interface for glucose monitoring. The MedStar device can now connect to and transmit physiological data from standard measurement devices regularly used at home by chronic disease patients with high blood pressure, diabetes, CHF and respiratory conditions. The MedStar collects data directly from the measurement devices and transmits it to a collection server over a standard telephone line.

Dade Behring (Deerfield, Illinois) received FDA clearance to make its D-dimer test available on its Stratus CS instrument, for use in STAT and central laboratories and in acute-care settings. An elevated D-dimer result reflects increased fibrin formation and lysis, indicating the presence of a clot, and has been reported in venous thromboembolic diseases, such as deep vein thrombosis, pulmonary embolism and disseminated intravascular coagulation. Symptoms for pulmonary embolism are often vague and may include chest pain. D-dimer provides another diagnostic tool that can be used in the rapid differentiation of chest pain, the company said. The turnaround time to determine D-dimer test results on the Stratus CS is about 14 minutes, including on-board sample centrifugation. The availability of the D-dimer method on the Stratus CS complements the system's ability to run heparinized whole blood samples, troponin I, myoglobin, mass CK-MB measurements and the BhCG test.

Epix Medical (Cambridge, Massachusetts) reported the selection of a compound, EP-2104R, to move toward clinical development. EP-2104R is an imaging agent specifically designed to enable detection of thrombus, or blood clots, in humans using magnetic resonance imaging (MRI). Epix said it expects to enter human trials with this contrast agent in 2004. Blood clots are implicated in several diseases, including deep vein thrombosis, pulmonary embolism, atrial fibrillation and stroke. It said blood clots are responsible for approximately 80% of the 700,000 strokes that occur annually in the U.S., and a variety of imaging tests are used to search for possible sources of clots in order to treat these patients. The company said that for many stroke patients, the source of the stroke is never detected using currently available imaging tests. Epix also will explore the detection of blood clots in patients with acute coronary syndromes.

EPMedSystems (West Berlin, New Jersey) said that it has submitted its ViewMate intracardiac ultrasound catheter system 510(k) filing to the FDA for regulatory approval. This is the company's second step in the process of the globalization of the ViewMate platform. The system received the CE mark in Europe in January. The ViewMate intracardiac ultrasound catheter system allows cardiologists and electrophysiologists to view the interior anatomy of the heart, allowing them to diagnose and treat a number of heart abnormalities.

Guidant (Indianapolis, Indiana) reported FDA approval of its next-generation implantable defibrillator, the Vitality AVT implantable cardioverter defibrillator (ICD) system. The new technology combines complete ventricular and atrial therapies in what the company calls the world's smallest (30cc) and thinnest (11mm) dual-chamber ICD. Full commercial launch of the Vitality AVT ICD in the U.S. will occur later this quarter. The Vitality AVT ICD's atrial options include atrial rhythm classification, an algorithm designed to distinguish between benign atrial arrhythmias and those that may adversely affect ventricular rate; atrial overdrive pacing, designed as an option to maintain a normal rhythm; ventricular rate regulation, an algorithm designed to stabilize the ventricular rate during an atrial arrhythmia; and atrial programming options to convert the heart back to a normal rhythm, either automatically or using Guidant's Partner Rhythm Assistant. Guidant also reported FDA approval of the Ventak Prizm AVT implantable cardioverter defibrillator. The Prizm AVT ICD, like the Vitality AVT ICD, includes advanced therapies and diagnostics to treat arrhythmias that originate in either the upper or lower chambers of the heart. The Prizm AVT ICD has been available outside the U.S. since May 2001.

International Technidyne (ITC; Edison, New Jersey), a division of Thoratec (Pleasanton, California), has introduced the Hgb Pro Professional Hemoglobin Testing System for fast total hemoglobin testing in physicians' offices. The new system consists of a portable, battery-powered instrument and single-use test strips, which provide precise results in less than 30 seconds. It requires a small sample size of 15 microliters and is easy to use. Due to its small size, it can be used anywhere in the physician's office or clinic. ITC said it believes that these attributes will expand hemoglobin testing in physicians' offices, group practices and clinics.

Medtronic (Minneapolis, Minnesota) last month reported the first U.S. implant of the InSync III Marquis implantable cardioverter-defibrillator (ICD) system and the start of a new clinical trial of the company's newest-generation cardiac resynchronization therapy (CRT) device for high-risk heart failure patients. It also began a clinical trial for the Medtronic Attain Bipolar OTW (over-the-wire) left-heart lead. The first implant of the InSync III Marquis device took place at the Mid America Heart Institute of Saint Luke's Hospital (Kansas City, Missouri). "This device combines the best of the InSync III and the InSync Marquis systems, with important new functions that are designed to improve the effectiveness of cardiac resynchronization therapy," said Ursula Gebhardt, vice president and general manager of Medtronic's Heart Failure business, in a company statement. The InSync III and InSync Marquis devices were approved by the FDA earlier this year. The Attain Bipolar OTW lead, part of a growing family of leads and delivery systems offered to physicians doing implants of bi-ventricular pacing and ICD systems, is the next-generation, left-heart lead designed specifically for cardiac resynchronization therapy. It is a steroid-eluting, 6 Fr lead that can be delivered by stylet or guidewire and is designed to be maneuvered within cardiac veins and provide stability once in place. The first implant in that clinical trial was performed at Christ Hospital (Cincinnati, Ohio) during the implantation of an InSync ICD. Medtronic is conducting this multicenter trial in the U.S. and Canada. Medtronic also said that full enrollment has been reached for the CARE-HF (Cardiac Resynchronization in Heart Failure) clinical trial in Europe, a study of mortality and morbidity among moderate-to-severe heart failure patients who receive cardiac resynchronization therapy. The CARE-HF trial enrolled more than 800 patients at 82 clinical centers in 12 European countries. It has the largest control group of any heart failure trial to date (404 patients receiving optimal medical therapy from drugs) and is the most statistically robust heart failure trial due to the size of its control group and the length of follow-up, the company said. It is designed to evaluate the long-term outcome of cardiac resynchronization therapy on the mortality and morbidity of patients with heart failure due to left ventricular dysynchrony. CARE-HF is the only heart failure trial powered to assess the impact of cardiac resynchronization therapy alone on mortality and morbidity, according to Medtronic.

Orqis Medical (Lake Forest, California) received an investigational device exemption (IDE) from the FDA last month to perform feasibility trials of its Cancion family of minimally invasive Cardiac Recovery Systems (CRS) for use in treating early stage congestive heart failure (CHF). The company said the CRS systems offer a clear contrast to the standard therapy for those who go to a hospital for treatment of late-stage CHF. The standard treatment is drugs a regimen that commonly works, at first, but with these patients repeatedly returning for treatment until drug therapies finally, inevitably, fail. By contrast, Orqis says its system provides a rather simple method for avoiding drugs, supporting the heart in its primary functions pushing against a column of blood and thus giving it time to rest and, hopefully, recuperate. The system uses two cannulas. One goes into the femoral artery and takes blood out of that artery using a centrifugal pump. The other goes into the opposite femoral artery at the site of the descending aorta. The less-invasive Cancion process requires only cannula insertion and local anesthesia. This means shorter hospital stays or the avoidance of hospitalization altogether, the company said. The system has the CE mark and other studies are ongoing in Europe to bolster rollout there later this year. Cancion is built on technology developed by Dr. Steve Bolling at the University of Michigan (Ann Arbor, Michigan).

PharmaNetics (Raleigh, North Carolina) filed a 510(k) submission with the FDA for its Thrombin Inhibitor Management Test for the rapid management of Angiomax, an anticoagulant developed by The Medicines Company (Parsippany, New Jersey). This test is based on PharmaNetics' Thrombolytic Assessment System technology platform. PharmaNetics holds the exclusive worldwide license for the use of the reagent ecarin in detecting the effect of direct thrombin inhibitors. The company also said that its ENOX test is receiving a positive reception among interventional cardiologists, with nearly 60 hospitals now conducting evaluations in cardiac cath labs.

Quinton Cardiology Systems (Bothell, Washington) has started shipping the new Atria 3000 ECG under the Burdick brand name. The compact system is designed primarily for use in physicians' practices. This new 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 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.

Respironics (Murraysville, Pennsylvania) reported results from a randomized clinical trial of patients with heart failure conducted at Toronto General Hospital, University Health Network, Mount Sinai Hospital and the Toronto Rehabilitation Institute and funded in part by an unrestricted research fellowship from the company. The study tested 24 patients with heart failure who also had obstructive sleep apnea. All patients were on medication for their heart failure. Twelve participants were then randomly assigned to receive medical therapy alone and the other 12 were randomly assigned to receive treatment for their heart failure as well as treatment for their obstructive sleep apnea using Respironics' device called continuous positive airway pressure (CPAP). CPAP consists of a small mask that is placed over the nose during sleep and is connected by tubing to an air pressure pump that is plugged into a wall socket. Air pressure in the tubing is transmitted to the mask and then flows continuously through the nose into the throat, propping it open and preventing it from collapsing during the night. The results of the study were published in the March 27 issue of The New England Journal of Medicine.

St. Jude Medical (St. Paul, Minnesota) said it has received FDA approval to release the Identity ADx DR and Identity ADx XL DR pacemakers, with launch planned for this month. Dr. Derek Rodrigues, MD, performed the first Identity ADx pacemaker implant on March 27 at Overlake Hospital Medical Center (Bellevue, Washington). The St. Jude Medical Identity ADx pacemakers are the first models in the company's Team ADx product family. The devices incorporate AT/AF discrimination and diagnostic features, building upon features in previous St. Jude pacemakers, including the AF Suppression algorithm and Beat-by-Beat AutoCapture Pacing System. St. Jude said it plans to launch additional models of Team ADx devices this month. The Integrity ADx and Verity ADx pacemakers will follow the Identity ADx in the next several months, offering physicians more choices in feature sets and header configurations, the company said. St. Jude also reported two milestones for its new IsoFlex family of cardiac pacing leads. The FDA approved the IsoFlex S (silicone) pacing lead and the first implant of the IsoFlex P (polyurethane) pacing lead took place under an FDA investigational device exemption study. Paul Safer, MD, performed the first implant of the lead at Middlesex Hospital (Middletown, Connecticut). The IsoFlex P lead's reduced diameter allows it to be threaded through a 7 Fr introducer sheath. Both the IsoFlex S and IsoFlex P pacing leads are manufactured in straight and J shapes, allowing for ventricular and atrial use, respectively. The leads also are available in bipolar or unipolar configurations. The IsoFlex S lead has been available in the European Union since early this year. The IsoFlex P lead continues to be evaluated as part of a clinical study, with FDA approval expected later this year.

Synthetic Blood International (SYBD; Costa Mesa, California) said the FDA has requested minor revisions to the Phase I clinical study protocol in the investigational new drug application (IND) that SYBD submitted for Oxycyte in February. The company said it completed revisions to the protocol and submitted an amendment to the IND on March 27. Oxycyte is SYBD's perfluorocarbon-based blood substitute and therapeutic oxygen carrier. SYBD also said that the company is in negotiations with private investors for new funding that will finance the Phase I study and a Phase II clinical testing program that is expected to form the basis for Phase III clinical testing. The company plans to move manufacturing of Oxycyte to a contract pharmaceutical manufacturing firm in Southern California.

The FDA last month approved Thoratec's (Pleasanton, California) premarket approval supplement (PMA-S) allowing the use of its HeartMate XVE left ventricular assist device (LVAD) for destination therapy. That device would immediately supplant the HeartMate VE for all destination therapy indications in the U.S., the company said. The XVE is an enhanced version of the HeartMate VE device, approved last November for use in destination therapy, or permanent support for end-stage heart failure patients who are not eligible for heart transplantation. That approval marked the first time that a ventricular assist device has been approved to provide permanent support for these patients. "The XVE incorporates a number of significant improvements over earlier versions of the HeartMate VE and since its introduction some 15 months ago has performed very well in approximately 75 years of cumulative VAD patient days experience as a bridge to transplant," Keith Grossman, president and CEO of Thoratec, told Cardiovascular Device Update. "The device changes were designed to ease implantation, provide for longer and more reliable device life and improve patient outcomes." He added, "According to clinicians, patients on the device have experienced a significantly lower rate of complications, with many types of incidents virtually eliminated." Grossman noted that the XVE's technological advances are based on the experience in the landmark Randomized Evaluation of Mechanical Assistance for the Treatment of Congestive Heart Failure (REMATCH) trial. The FDA approval of the VE for destination therapy was based on the results of that trial, which compared the experience of patients supported by the device with those being treated with optimal medical management. Under the approval, the Thoratec device can be used to support patients with New York Heart Association Class IV end-stage left ventricular failure who have received optimal medical therapy for at least 60 of the last 90 days, have a life expectancy of less than two years and are not candidates for cardiac transplantation.

Velocimed (Minneapolis, Minnesota) said it has received the CE mark for the Proxis Embolic Protection System, the first proximal embolic protection device designed for coronary applications. The company said it expects to launch the product in international markets early this summer. The system is deployed in a proximal segment of the target vessel, upstream of the blockage. The Proxis System briefly occludes the target vessel, stagnating blood flow. Embolic debris created during stent deployment becomes suspended in the vessel and is then evacuated by reversing flow with a syringe. The FASTER clinical trial, which involved 35 patients treated with the device at three centers in Germany, demonstrated the safety of the Proxis System, according to the company. The vessels treated in the study included both bypass graft and native coronary vessels. The trial had a very low MACE (major adverse cardiac event) rate of 5.7% (two out of 35 patients). The two MACE events were not directly related to the device. The Proxis system is the first in a series of proximal embolic protection devices that Velocimed is developing for use in coronary, carotid and peripheral applications.

V.I. Technologies (Watertown, Massachusetts) said it has completed the recruitment of the clinical trial study sites for the company's chronic transfusion study. These sites will be more than sufficient to enroll the 70 patients requiring chronic transfusion support in its pivotal Phase III trial for Inactine pathogen reduction red blood cells, the company said. The Inactine pathogen reduction red blood cell system is being developed to protect patients requiring red cell transfusions from disease-causing pathogens. All patients participating in the Phase III study will have documented sickle cell disease or thalassemia, and will have been enrolled on a chronic transfusion program involving standard patient care of either simple or exchange transfusions. The Phase III Inactine red blood cell program consists of the chronic transfusion study and a second study in patients requiring acute transfusion support. Both studies will evaluate the safety and effectiveness of Inactine-treated red blood cells. The second study involves 200 cardiac surgical patients requiring acute transfusion support.

WorldHeart (Ottawa, Ontario) has received a letter from the FDA regarding the agency's review of the company's destination therapy premarket approval supplement for the Novacor LVAS (left ventricular assist system). The FDA has requested additional data and statistical analyses in areas such as recipient demographics and adverse events. In addition, the FDA has asked that WorldHeart supply data in an electronic format in order to conduct modeling analyses of various data subsets. WorldHeart said it has begun preparation of the information and has indicated to the FDA that substantive responses to the questions will be provided. WorldHeart said it intends to provide "timely input" to the agency with the target of a late summer or fall panel review. Novacor LVAS is an electromagnetically driven pump that provides circulatory support by taking over part or all of the workload of the left ventricle. It is commercially approved as a bridge to transplantation in the U.S. and Canada. In Europe, the Novacor LVAS device has unrestricted approval for use as a bridge to transplantation, an alternative to transplantation and to support patients who may have an ability to recover the use of their natural heart. In Japan, the device is commercially approved for use in cardiac patients at risk of imminent death from non-reversible left ventricular failure for which there is no alternative except heart transplantation. Separately, clinical results for the Novacor LVAS with a new ePTFE (expanded polytetrafluorethylene) inflow conduit were presented at the annual scientific sessions of the International Society of Heart & Lung Transplantation in Vienna, Austria. The clinical results, based on the first 88 implants at 25 centers in Europe and Canada, demonstrated a 7.9% embolic cerebrovascular accident (CVA) rate, excluding two cases clinically confirmed to be non-device-related. After the 30-day perioperative period, the rate was 4.5%. The inflow conduit carries blood from the natural heart to the Novacor LVAS, which then pumps the blood into the aorta to assist a failing heart. The ePTFE inflow conduit was introduced to provide an alternate blood-contacting material, which has been documented to offer such benefits as a reduction in inflammatory response and platelet activation. The ePTFE conduit was previously approved in Europe, and recently approved in both Canada and the U.S.