A second player has officially arrived in the drug-eluting stent market with a European approval. Boston Scientific (BSX; Natick, Massachusetts) received the CE mark for its Taxus stent system in late January, joining Johnson & Johnson's (J&J; New Brunswick, New Jersey) Cordis (Miami Lakes, Florida) unit in the still-elite coated-stent club. The paclitaxel-eluting stent system uses Boston Sci's Express2 coronary stent system launched in the U.S. last September as its platform, and the company planned to launch the system this month in Europe and other international markets.
It has set its sights on the ultimate prize, a late-2003 launch in the U.S.
While BSX is ambitious, it still will be the second company to cross the U.S. approval finish line, giving J&J an expected several months of exclusive sales in the larger market, estimated to be worth between $2 billion and $3 billion annually. Cordis received the CE mark for its Cypher sirolimus-eluting stent last April, and the stent garnered a recommendation for approval from the FDA's Circulatory System Devices panel in late October. While conditions placed on the Cypher by the FDA panel, particularly a request for a small pharmacokinetic study, could slow down J&J's drive toward final clearance, the company still is expected to get the approval no later than March or April, giving it a likely two fiscal quarters and possibly more of U.S. sales exclusivity.
For its part, Boston Scientific is plenty excited about its entrance into the European market. "This is an historic day for our company and for the treatment of coronary artery disease," said Jim Tobin, president and CEO. He added that the company was "further encouraged" by recent data that demonstrates a "beneficial edge effect, improvements in diabetic patients, and the absence of systemic levels of paclitaxel."
William Hunter, MD, president and CEO of Angiotech Pharmaceuticals (Vancouver, British Columbia), which licenses paclitaxel to Boston Scientific, said, "the European approval and commercial launch of the Taxus coronary stent system is the most significant achievement and milestone event in our company's history." He added, "Our partner, Boston Scientific, has built a solid reputation in interventional cardiology by building superior products. The paclitaxel-eluting Taxus stent will be an important addition to that legacy."
In a webcast with market analysts at the time of the CE mark approval, Boston Scientific expressed optimism about its future growth potential, noting that its income for 4Q02 soared more than 62% amid what it termed "brisk U.S. sales" of the newly launched Express coronary stent. The company said that Express sales, coupled with the European approval of the Taxus system, spell "unprecedented market opportunities" for it in 2003 and 2004. BSX noted that it and J&J are expected to be the only companies offering coated stents which will be around triple the price of a bare-metal stent until 2005.
While Boston Scientific is still in second place in the drug-eluting stent market, it is hoping that its newer technology platform will ultimately win the day. "We won't be first, but we will be best," Tobin said in a media interview last month. He said his company has the advantage of having a drug-coated stent that uses new stent technology, compared with J&J's stent, which is about three years old. He said his company has been beefing up its European sales force in advance of its launch of the Taxus stent this month.
The company also said it would present its Taxus IV coated stent data to be used for an FDA submission at the Transcatheter Cardiovascular Therapeutics conference in Washington in September. The data on 1,326 U.S. patients will show how the stents performed after nine months.
Additionally, Boston Sci said it has completed enrollment in its TAXUS VI trial, an international study of 448 patients with complex coronary artery disease at 44 sites. It is designed to establish the safety and efficacy of the moderate-release formulation in the treatment of longer lesions (greater than or equal to 18 mm in length). The trial, which is using the Express stent and includes the use of multiple stents, has a primary endpoint based on nine-month target vessel revascularization.
Elsewhere in the product pipeline:
Alteon (Ramsey, New Jersey) reported positive results from a preliminary analysis of the Phase IIa DIAMOND (Distensibility Improvement and Remodeling in Diastolic Heart Failure) clinical trial evaluating the activity of ALT-711 in diastolic heart failure (DHF) patients. The DIAMOND trial is ongoing, and additional analyses of the data are being conducted. Patients who received ALT-711 for 16 weeks experienced a statistically significant reduction in left ventricular mass, in a preliminary analysis of the first 17 patients. The drug also had a positive effect on patients' quality of life, as measured by a heart failure/quality of life questionnaire.
AngioDesign (Lincoln, Nebraska) said it determined the 3-D crystal structure of angiotensin-converting enzyme (ACE), a finding reported in the Jan. 19 online edition of Nature. The newly formed company said improvements could be made on current ACE inhibitors hampered by common side effects by creating next-generation ACE inhibitors based on structure-guided drug design. Design of specific domain-selective ACE inhibitors is expected to produce next-generation drugs that are safer and more effective, the company said.
Angiotech Pharmaceuticals (Vancouver, British Columbia) reported "promising" results from its preclinical study of paclitaxel-loaded perivascular wraps for the treatment of restenosis associated with bypass vascular surgery. The final analysis of the large animal GLP efficacy study carried out at an independent lab has been completed. In a sheep carotid to carotid bypass model with a synthetic ePTFE (expanded polytetrafluorethylene) graft, an 85% reduction in percent diameter stenosis was achieved. The safety profile was excellent, there were no signs of toxicity and the vessel junction sites were fully healed, the company said.
Biotronik (Lake Oswego, Oregon) reported the first implant of its Protos pacemaker, that implant being placed in an 81-year-old female patient by William Bailey, MD, of the Heart & Vascular Center (Lake Charles, Louisiana). Biotronik calls the Protos "the world's only full-featured cardiac device capable of re-establishing a patient's natural cardiovascular control loop." The device received FDA approval last month. The company said the Protos pacemaker is the only product available on the market to translate signals sent from the autonomic nervous system to the heart to determine rate response. It features the company's Closed Loop Stimulation (CLS) technology for rate-adaptive pacing. Unlike traditional pacemakers, CLS translates cardiac signals, sent directly from the heart, to determine the appropriate heart rate, Biotronik said. Thus it not only responds quickly to demands initiated by physical exertion, but also to those triggered by mental demands and emotional stress, the company noted. Separately, Biotronik reported the commercial release of the Belos DR-T, which it said is the world's first dual-chamber, rate responsive implantable cardioverter defibrillator (ICD) that is designed to instantly and automatically notify a physician when a patient has received life-saving therapy without any involvement from the patient. The company said the new ICD reflects the company's commitment to innovative technology that helps improve patient outcomes while simplifying routines for healthcare providers. The Belos dual-chamber family received market approval from the FDA on Dec. 20, 2002. The DR-T is the flagship device of the company's Belos family of ICDs, which also includes the VR-T, DR and VR models. Belos dual-chamber ICDs use SMART Detection and Redetection, which Biotronik said are designed to be the most accurate and reliable AV discrimination features available to distinguish life-threatening arrhythmias from normal heart rhythms. Appropriate discrimination is vital because inaccurate detections may result in the delivery of unnecessary therapy that can be painful and stressful for patients. SMART Detection and Redetection are designed to be 100% sensitive in detecting ventricular tachyarrhythmias and achieve an unsurpassed 94% specificity for discriminating supraventricular tachyarrhythmias (SVTs) from potentially lethal ventricular tachyarrhythmias. Belos ICDs offer a full range of additional features, including a suite of anti-tachycardia pacing schemes (ATP). ATP therapy is emerging as an effective painless therapy option for treating certain types of arrhythmias.
Cardiac Science (Irvine, California), a manufacturer of automated public-access defibrillators (AEDs), said that the FDA has granted the company 510(k) clearance to market its Powerheart AED for use on children under eight years old. The FDA action clears the way for Cardiac Science to begin marketing its pediatric defibrillation electrode pad system specifically designed to optimize the Powerheart AED for use with small children. The pediatric electrode pads are significantly smaller than the standard pads to better fit the bodies of young children and have a built-in attenuating mechanism that decreases the energy delivered in the defibrillation shock, as smaller victims generally require less energy to be revived from sudden cardiac arrest.
Cardima (Fremont, California) said the Therapeutic Products Directorate of Health Canada has approved a license to market the company's Revelation family of ablation microcatheters for the treatment of atrial fibrillation (AF). The license covers the Revelation Tx, Revelation T-Flex and Revelation Helix. "With approval of these catheters, Canadian electrophysiologists will have the minimally invasive tools to create straight, curved and circumferential linear endocardial lesions to treat AF by replicating the surgical Maze procedure," said CEO Gabriel Vegh.
Concentric Medical (Mountain View, California) said the company has received approval to affix the CE mark to the components of the Merci (Mechanical Embolus Removal for Cerebral Ischemia) System, a minimally invasive approach to quickly restore flow to blocked vessels during ischemic stroke. The company believes its device is the first ever to receive this distinction for the mechanical removal of thrombus in the neurovasculature.
Cook (Bloomington, Indiana) has received a device license from Health Canada for the Zenith AAA Endovascular Graft System, a third-generation stent-graft system for the endovascular treatment of abdominal aortic aneurysms. Cook said the Zenith AAA Graft System goes far beyond the first-generation endovascular AAA systems currently available by including advanced features to improve fixation and reduce the likelihood of stent-graft leakage, problems seen in earlier AAA devices marketed in the U.S. and elsewhere. Developed jointly by Cook companies in the U.S., Europe and Australia, the Zenith system has been clinically shown to lower morbidity rates, reduce recovery time and improve quality of life for patients undergoing endovascular AAA repair compared to open surgical procedures. Cook's system treats these aneurysms without the need for major surgery. Patients treated with the Zenith system require just two incisions to allow the insertion of two catheters into the femoral arteries in the groin. Once the catheters are guided into position through the patient's arteries, a fabric-covered, self-expanding metal stent-graft is deployed inside the weakened section of the aorta and the surrounding vessels to relieve pressure on the aneurysm.
CryoVascular Systems' (Los Gatos, California) PolarCath System which uses a new form of angioplasty to open blocked arteries by cooling and dilating them appears to be more successful and result in fewer complications than conventional balloon angioplasty. Early multicenter results using the PolarCath Peripheral Transluminal Angioplasty System to treat blocked leg arteries were presented at the International Symposium on Endovascular Therapy (ISET) meeting in Miami Beach, Florida. At nine months, 85% of the treated lesions remained patent, which is significantly better than expected patency rates for either angioplasty or stenting. PolarCath has a balloon system that is advanced to the site of the blockage and filled with liquid nitrous oxide, which evaporates into a gas upon entering the balloon. The evaporation process cools the balloon to specific sub-freezing temperatures, thereby cooling the plaque and vessel wall as it dilates the vessel. This is believed to crack the plaque and aid in reshaping it with minimal injury to the vessel wall, and consequently with minimal inflammation. In traditional angioplasty, the balloon is filled with saline and the walls of the clogged artery are compressed, causing injury in the vessel that triggers an inflammatory response. This inflammation in turn causes a reclogging of the artery or restenosis. An estimated 40% or more of femoropopliteal angioplasties (angioplasty in the legs) result in restenosis within nine months to one year. The PolarCath Peripheral Transluminal Angioplasty System is approved by the FDA and will be commercially available in the U.S. this year. The device has been available in Europe since last year.
Estech (Danville, California) said it has established marketing agreements for its cardiovascular surgical products with partners in what it calls "key international markets." It has formed distribution agreements with Getz Bros. for Japan and other Asia-Pacific markets, Krauth Medical for Germany and Downuri in Korea. "The distribution organizations we have added for these major international markets are well recognized as the leading distribution organizations for cardiovascular surgery products in their respective markets," said Raymond Bertolero, vice president of sales and marketing for Estech. Estech is focused on technologies for what it terms Least Invasive Cardiac Surgery (LICS), using both beating heart and stopped heart surgical approaches. It reports its beating heart products are used in more than 40,000 procedures.
ev3 (Plymouth, Minnesota), a privately held endovascular company, said the Protege GPS stent is the latest version of the Protege self-expanding stent line ev3 obtained with its acquisition of IntraTherapeutics in November 2002. The Protege GPS self-expanding stent is a laser cut, nitinol stent that features tantalum markers on the stent ends to increase radiopacity and assist in visualization for accuracy of stent placement. The Protege GPS stent has gained clearance for use in the biliary system. The original version of the Protege stent is also under study to determine its safety and effectiveness in treating patients with peripheral vascular disease of the iliac artery. The company said the GPS stent has several unique performance characteristics. It is extremely accurate to place because it does not shorten at any expanded diameter range. The stent also features the EX.P.R.T. placement technology designed to eliminate any stent jumping by anchoring the proximal stent tips to a securement ring. The StarPort technology offers the ability to inject contrast media through the body of the catheter, allowing visualization prior to stent placement.
First Hypertension Diagnostics (St. Paul, Minnesota) said it has been advised that ShenZhen Filiale ShenYong Medical-Pharmacal, the company's distributor in China, has received approval from the Chinese State Drug Administration to import and market the CVProfilor DO-2020 CardioVascular Profiling System in that country. The CVProfilor System is used non-invasively for screening, diagnosing and monitoring the treatment of patients with cardiovascular disease and for clinical research studies, including evaluations of cardiovascular drugs.
Guidant (Indianapolis, Indiana) continued its recent rapid pace of approvals in the congestive heart failure (CHF) arena with the mid-January FDA clearance of the Contak Renewal cardiac resynchronization therapy defibrillator (CRT-D). The company said full commercial launch of the advanced heart failure therapy system began immediately. The device will compete with Medtronic's InSync ICD system, which gained FDA approval last June. The implantable Renewal device combines a pacemaker to help regulate a patient's heartbeat with a defibrillator aimed at resuscitating patients with dangerously fast heart rhythms. It is the third CRT-D device from Guidant that U.S. regulators have approved in the past year. The company received formal approval of its Contak CD/EasyTrak system in May. The next generation of that device, the Contak CD 2, received FDA approval in October, with Guidant saying at the time that it was the second in a "deep pipeline" of cardiac resynchronization therapy defibrillators. According to the company, the Renewal is the first system designed specifically for patients and physicians struggling with heart failure. The system contains new diagnostic capabilities that are designed to help physicians better manage their patients' conditions. The Renewal provides both cardiac resynchronization therapy and implantable defibrillator therapy, to address both of the principal mechanisms by which heart failure patients die pump failure and sudden cardiac death. Included in the array of new diagnostics and therapeutic features in the Renewal CRT-D is the incorporation of a left ventricular protection period, a feature specifically designed to prevent potentially pro-arrhythmic left ventricular pacing, which may occur without adequate left-side sensing. The Renewal also introduces two new heart failure-specific diagnostic features. The first monitors heart rate variability (HRV); the second, called Activity Log, uses data from a motion sensor to track trends in the patient's activity. The HRV diagnostic tool is the first of its kind to be incorporated into a CHF device, the company said.
i-STAT (East Windsor, New Jersey), a manufacturer of point-of-care diagnostic systems for blood analysis, said that clinical trials of an i-STAT System cartridge to detect the presence of cardiac troponin I (cTnI), a marker observed in patients who have suffered myocardial injury (i.e., heart attack), are underway. These trials are designed to support a 510(k) submission that the company intends to file with the FDA in the spring, seeking clearance to market this test. With the addition of cTnI, the capabilities of the i-STAT System are expanded to immunoassays, a major addition to the electrolyte, blood gas, chemistry, coagulation and hematology capabilities already available on the i-STAT System, the company said.
Medtronic Physio-Control (Redmond, Washington) has introduced what it calls its "most rugged automated external defibrillator [AED]," the Lifepak 500 DPS, designed for medical emergencies in difficult and dangerous settings. The Lifepak 500 DPS AED, it said, was tested to military specifications to operate at higher altitudes and withstand shock, vibration, dust, fog and salt, and "is ideal for use in outdoor and mobile settings, such as law enforcement, public safety, utility work, underground mining operations, on helicopters, at the scene of a natural disaster or for search and rescue operations." It was tested to operate at altitudes from minus 2,000 feet to 15,000 feet and to withstand higher levels of shock and vibration. The Lifepak 500 DPS also is compatible with Lifepak defibrillator/monitors, used by 80% of the emergency medical services, according to Medtronic Physio-Control. The company, a unit of Medtronic, reports more than 350,000 Lifepak devices distributed worldwide.
Medtronic (Minneapolis, Minnesota) launched the Xpedient Delivery System for its AneuRx AAA Stent Graft System, which repairs abdominal aortic aneurysms through a minimally invasive endovascular repair procedure. The AneuRx stent graft with the Xpedient Delivery System, now available in the U.S., will make deployment easier for physicians, while facilitating delivery through tortuous vasculature. Medtronic AVE, the company's Vascular Division, is headquartered in Santa Rosa, California. Indicated for the treatment of abdominal aortic aneurysms, the AneuRx system has emerged as the minimally invasive system of choice for those physicians whose patients, because they are elderly, frail or suffer from multiple illnesses, are considered high-risk candidates for surgical repair of their aneurysms, the company said.
Neoprobe (Dublin, Ohio), a developer of oncology and cardiovascular surgical and diagnostic products, was issued U. S. patent No. 6,503,205 covering key aspects of the blood flow measurement technology of its wholly owned Cardiosonix (Hod Hasharon, Israel) subsidiary. The claims of the patent cover a broad scope of Cardiosonix innovations in the measurement of blood flow in a variety of clinical settings including neurosurgery, cardiovascular surgery and intensive care. The technology is based upon its proprietary ADBF technology that is included in the recently issued patent. The Quantix/ND, Cardiosonix' first product for the measurement of cerebral blood flow, has received regulatory clearances for marketing in the U.S. and Europe. Neoprobe began shipments of the Quantix/ND to distributors in Europe during 4Q02. Separately, Neoprobe said Cardiosonix received clearance to begin marketing of the Quantix/OR in Europe. The Quantix/OR received CE mark clearance to begin marketing for the intraoperative measurement of blood flow in various surgical settings. Neoprobe said it expects to begin commercial shipment of the first Quantix/OR systems to certain European markets this quarter. The Quantix/OR system includes a control unit and two Doppler probes that can measure blood flow in vessels of various sizes and can be used during coronary or other bypass procedures to determine graft patency or it can be used prior to the harvesting of a native artery for a bypass procedure to ascertain quality of flow.
Novoste (Norcross, Georgia) said the FDA has approved its premarket approval supplement for the B-Rail 3.5F Delivery Catheter and that it intends to immediately begin re-release of the product to customers. The PMA supplement was filed, and improvements were made to the catheter, after the company initiated a voluntary recall of the product last August. The improved B-Rail 3.5F Delivery Catheter has undergone changes in manufacturing and specifications, "resulting in a more robust tip and positioning the product as a competitive vascular brachytherapy device in the market, based on comparative testing submitted to the FDA in the PMA supplement," the company said. Novoste also reported the introduction of the B-Cath 5F 60 mm XL Delivery Catheter, an addition to the 5F product line that capitalizes on customer demand for longer catheter lengths and enables clinicians to use the company's longer 60 mm radiation source train for coverage of long lesions.
OmniSonics Medical Technologies (Wilmington, Massachusetts), a developer of products to treat vascular occlusive disease based on its patented OmniWave Technology platform, said clinical researchers presented preliminary data on the Resolution System at the International Symposium on Endovascular Therapy (ISET) in Miami Beach, Florida, last month. John Lipman, MD, director of the Center for Minimally Invasive Therapy (Atlanta, Georgia), discussed preclinical and clinical results of the Resolution System in the treatment of thrombosed hemodialysis access grafts. The Resolution System uses acoustic energy to resolve occlusive materials, such as blood clots, into particles approximately the size of red blood cells, without causing harm to blood vessel walls. The Resolution System, which is cleared for marketing in Europe, consists of three main components: a generator, handpiece and the Resolution 360 Therapeutic Wire.
Qmed (Eatontown, New Jersey) said researchers from several institutions published an article regarding the company's physician decision support and disease management system for coronary artery disease. The paper was published in Disease Management, the peer-reviewed journal of the Disease Management Association of America (Washington). While the paper details an early version of the company's program for coronary artery disease for 39,565 members over 21 months in a California medical group practice, the outcomes parallel recently announced data showing up to 37.1% reductions in heart attacks coupled with substantial cost savings. The study showed that costs declined 17% for the 21 months of the study, while health and utilization rates also showed statistically meaningful improvements for example, heart attacks were reduced by 30%.
Excimer laser developer Spectranetics (Colorado Springs, Colorado) reported at last month's Interventional Symposium on Endovascular Therapy that data from its Laser Angioplasty to treat Critical Limb Ischemia (LACI) pivotal Phase II clinical trial showed promising results. Just two days later, the company filed a premarket approval supplement (PMA-S) based on that positive LACI trial data. The study data, on which the PMA-S was based, showed that six-month survival with limb salvage, which is the primary clinical endpoint of the study, was achieved in 93% of the limbs treated, compared with 87% in the control group. Additionally, significant adverse events in treated patients were nearly one-half that of the control group at 33% and 60%, respectively. The trial enrolled 145 patients (155 limbs) at 14 domestic and several European sites. The control group was comprised of 789 patients with critical limb ischemia treated with a variety of standard therapies. Outcomes for this group were published in The Annals of Internal Medicine in 1999. Spectranetics said it hopes that the PMA-S backed with the data from the LACI trial will soon result in another approval for its CVX-300 excimer laser, already cleared by the FDA for multiple cardiovascular procedures, including coronary atherectomy, the treatment of in-stent restenosis prior to radiation therapy and the removal of problematic pacemaker and defibrillator leads. The trial included the use of coronary catheters as well as larger-diameter catheters ranging from 2.2 mm to 2.5 mm. The company also has another trial under way, the Peripheral Excimer Laser Angioplasty (PELA) trial, which deals with blockages in arteries in the upper leg. That trial is about two to four months behind LACI, Spectranetics said, because the enrollment period was a little bit longer.
St. Jude Medical (St. Paul, Minnesota) said it has reached minimum enrollment requirements for its large multicenter Cardiac Resynchronization Therapy Post AV Node Ablation Evaluation, or PAVE study. A total of 328 patients at 47 centers in the U.S. and Canada have been enrolled. The PAVE study was designed to evaluate if an increase in exercise capacity can be realized using a biventricular stimulation device versus a conventional right ventricular single-chamber pacemaker in patients following an AV nodal ablation procedure for rate control of chronic atrial fibrillation. The primary endpoint of the study is exercise capacity, as measured by the distance walked during a six-minute walk test. Secondary endpoints include peak VO2 measurement and health-related quality of life. Patients are evaluated at baseline and six months. Patients enrolled in the PAVE study have been diagnosed with chronic atrial fibrillation, which their physician has elected to treat with AV nodal ablation, an interventional procedure during which an ablation catheter is used to burn a small area of cardiac tissue in the AV node of the heart. The PAVE study compares two different types of pacing in this specific patient population: conventional pacing in the right ventricle only and the newer approach of biventricular pacing, in which the heart is synchronized by being paced in both the right and left ventricles. St. Jude also said the FDA has approved new labeling for its 6F Angio-Seal STS vascular closure devices following completion of an investigational device exemption (IDE) study that demonstrated how the device "significantly reduces the time to patient ambulation and discharge following diagnostic procedures," the company said. The IDE study demonstrated how the 6F Angio-Seal STS device can reduce the time to patient ambulation following diagnostic angiography procedures, showing 35% of patients ambulating in less than five minutes and the majority ambulating within 10 minutes. The study also resulted in no major complications. In another piece of company news, St. Jude reported the first U.S. implant of its SJM Epic stented porcine tissue valve under a FDA investigational device exemption (IDE) clinical study. Dr. Vibhu Kshettry, a cardiovascular surgeon with the Minneapolis Heart Institute at Abbott Northwestern Hospital (both Minneapolis, Minnesota), implanted the SJM Epic valve in an 85-year-old male patient suffering from aortic stenosis. The procedure was successful and the patient is recovering and doing well. The SJM Epic valve incorporates the design features of the SJM Biocor valve, which has a 17-year clinical history of outstanding durability and reliability. In addition, the SJM Epic valve features the company's Linx anticalcification technology, designed to alleviate the calcification problems sometimes associated with tissue valves.
Theragenics (Buford, Georgia), manufacturer of the TheraSeed device, began the TheraP clinical trial at Fuqua Heart Center of Atlanta at Piedmont Hospital (Atlanta, Georgia). The study will test the safety and feasibility of the company's TheraSource Intravascular Brachytherapy System designed to prevent restenosis of leg arteries following treatment of peripheral vascular disease by percutaneous transluminal angioplasty (PTA). The TheraP trial is a safety and feasibility study that will include 30 patients in up to three centers. Patients will receive standard PTA, followed by vascular brachytherapy. Enrollment is expected to be complete by July. The TheraSource Intravascular Brachytherapy System deploys a palladium-103 coated wire through a balloon catheter. The characteristics of the isotope are well suited for use in the peripheral vascular system, enabling distribution of the prescribed dose to the target tissue, while minimizing dose to non-target tissues. The low-energy X-rays emitted by TheraSource are designed to substantially reduce shielding requirements and eliminate the need for remote afterloading equipment, creating a safer environment for hospital personnel, the company said.
World Heart (Ottawa, Ontario) has received approval from the FDA for an ePTFE inflow conduit as a component of its Novacor LVAS (left ventricular assist system). 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 conduit, which was developed by World Heart, uses expanded polytetrafluoroethylene (ePTFE) graft material, and was previously approved for commercial use in the European Union. The FDA has requested that World Heart submit a report documenting the results of the first 20 U.S. implants post-approval. 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. World Heart has filed a premarket approval supplement with the FDA seeking destination-therapy indication for the Novacor LVAS.