News from the invasive cardiology field

Terumo Announces the Release of its Pinnacle R/O II Introducer Sheath with Radiopaque Marker Terumo Medical Corporation has just released its newest vascular access product: the Pinnacle R/O II Introducer Sheath with Radiopaque Marker. The new R/O II sheath features an innovative construction that delivers the flexibility needed for sustained patency even in tortuous anatomy. A platinum/iridium band assures exceptional visibility under fluoroscopy, identifying the precise location of the distal tip throughout the procedure. In order to meet a wider range of size needs and preferences, the Pinnacle R/O II sheath line has been expanded to include a new 6cm length to accompany the traditional 10 and 25cm versions. All three lengths will be available in 6, 7 an 8 French sizes. the Pinnacle R/O II will be sold in the United States and Latin America exclusively by Boston Scientific Corp. Security Officer At Seattle Center Uses Defibrillator to Save Fellow Officer From Sudden Cardiac Arrest The 74-acre Seattle Center, with the Space Needle, Opera House, Experience Music Project, and KeyArena, seemed about as quiet as it can get shortly after dawn on October 19. However, just after arriving to begin his tour of patrol, Security Officer Paul Eytchison felt chest pains and sat for a moment on a couch in the operations center. Minutes later, he slumped sideways onto the couch, eyes open, breathing hard. Then the breathing almost disappeared. No pulse. Nearby, Douglas noticed and went into action. He alerted 911, recalled his training, and thought Eytchison might be in Sudden Cardiac Arrest, a heart condition that is fatal unless help arrives in minutes. Douglas recognized that seconds count and called immediately for the Medtronic LIFEPAK® 500 automated external defibrillator (AED) to be brought from its wall mounting in the operations center. He tore off Eytchison's shirt and applied electrode pads from the AED to his chest. The AED's display screen almost immediately carried the shock message and Douglas pushed the button. The first shock did it. Eytchison stirred. The pulse returned. Douglas started cardiopulmonary resuscitation. Fire Department medics arrived soon, with an ambulance close behind. Eytchison was taken to Harborview Medical Center where physicians verified that he was susceptible to tachyarrhythmia and ventricular fibrillation, a condition in which the heart beats too fast to allow the efficient pumping of blood. A few days later, Eytchison was implanted with an internal defibrillation device designed to protect him from recurrence. He's back on the job now and quick to credit his fellow officer: My survival is directly related to the quick response by Randy and his knowledge of the AED and its use, Eytchison says. All I can say is that I am eternally grateful he was at work that day. An effort to place AEDs at sites where people gather is gaining momentum nationwide. More than 40,000 of the devices have been deployed nationally in police cars, commercial airliners, airports, hotels and casinos, sports arenas, high schools, manufacturing plants and other public places. Revolutionary New Film Eliminates the Potential for Serious Radiation Burns During Fluoroscopy Procedures Nuclear Associates™ new GAFCHROMIC XR “ Type R Dosimetry Media was specially developed in response to a growing concern regarding serious radiation induced skin injuries during fluoroscopy procedures. Until now, there has been no clear-cut way of measuring and mapping exactly how much and where radiation was distributed on the patient. Gafchromic XR “ Type R tells you exactly where the dose was distributed. Possis Medical, Inc. Receives Award from Popular Science Magazine The editors of Popular Science magazine have chosen the AngioJet® XMI catheter as a winner in the Medical Technology category for the Best of What's New for 2001. The XMI catheter was featured in the September 2001 issue of the magazine. In the December issue of Popular Science, the XMI was chosen as one of the 100 winners in ten categories. Each award winner represents a significant step forward in its category. More important, each winner must in some way improve the quality of life whether the product or technology is intended to entertain, heal the sick, or advance the body of human knowledge. Favorable Cost-Effectiveness Results Featured Among New Study Findings for INTEGRILIN® (eptifibatide) Injection Use of Integrilin is highly cost-effective at $1,407 per year of life saved in patients undergoing an intracoronary stent procedure. The cost-effectiveness profile for Integrilin compares favorably to the cost of many commonly used cardiac medications and procedures; for example, the cost per year of life saved with aspirin for the primary prevention of heart attack is $4,000. The cost-effectiveness of Integrilin was evaluated as part of the long-term, follow-up phase of the ESPRIT study in 2,064 patients undergoing coronary stent procedures which demonstrated a maintenance of a statistically significant reduction in the combined incidence of death or heart attack at one year. The economic analysis demonstrated that because of its positive impact on reducing complications related to the heart procedure, use of Integrilin increased costs by less than $300 per patient significantly lower than the drug™s acquisition cost ($495). At the end of the first year of follow-up, the net cost of Integrilin to the health care system was only $146 because of further reductions in late complications. Since the completion of the ESPRIT trial and the release of the favorable long-term results, use of GP IIb/IIIa inhibitor therapy has been the standard of care for virtually all patients undergoing coronary stent procedures at our institution, stated David Cohen, MD, Associate Director of Interventional Cardiology at the Beth Israel Deaconess Medical Center in Boston, Massachusetts and Principal Investigator for the ESPRIT economic study. Given the affordable cost of Integrilin and its highly favorable cost-effectiveness profile, there is no reason why physicians, hospital administrators, or payors should restrict access to GP IIb/IIIa inhibitor therapy in the catheterization laboratory One-year efficacy results for the subset of 467 diabetic patients enrolled in ESPRIT, a group at high risk for procedural complications, showed that Integrilin reduces the combined incidence of death and heart attack from 13.4 percent with placebo to 7.8 percent at one year. Consistent reductions in events were reported in insulin-dependent, medication-controlled, and diet-controlled diabetic patients. The results of the CRUISE study, designed to evaluate the potential utility of Integrilin combined with either unfractionated heparin or enoxaparin, a low-molecular-weight heparin, demonstrated similar safety and efficacy outcomes for both treatment groups in 261 patients undergoing intracoronary stenting. Final study results from the Phase II INTEGRITI study indicate that Integrilin plus a half dose of the clot-buster agent, tenecteplase, opened or reperfused occluded arteries within 60 minutes in 20 percent more patients than tenecteplase alone. Results from the continuous ST-segment monitoring sub-study from INTEGRITI, entitled ASTRONAMI, revealed that use of Integrilin in combination with half-dose tenecteplase improved measures of reperfusion, extent of reperfusion, and maintenance of reperfusion more than full-dose tenecteplase alone. While the incidence of intracranial bleeding was not increased in the combination arm, bleeding at the site of catheter placement trended higher. The INTEGRITI and ASTRONAMI study results suggest that a combination of Integrilin plus half-dose tenecteplase opens occluded arteries prior to early catheterization and revascularization. RAPIER study results also revealed that Integrilin alone, administered without fibrinolytic therapy, in the Emergency Department to patients with ST-segment elevation MI helped to open up occluded arteries prior to early catheterization and intervention. The investigators for the trials consider these findings important given that previous studies have shown that patients with open arteries experience fewer adverse complications following revascularization than those with occluded arteries. As a result of these study findings, as well as current trends in U.S. MI patient management, investigators announced the initiation of the ADVANCE MI (ADdressing the Value of facilitated ANgioplasty after Combination therapy or Eptifibatide monotherapy in acute Myocardial Infarction) study, which has been designed to evaluate the safety and efficacy of Integrilin with or without half-dose tenecteplase in patients with ST-segment elevation myocardial infarction who are to undergo direct percutaneous coronary intervention. The approximately 6,000 patient study will be jointly coordinated by the Thrombolysis in Myocardial Infarction (TIMI) research network at Harvard University and the Duke University Clinical Research Institute (DCRI). Guidant Defibrillator Cut Deaths in Study, Trial Stopped A clinical trial of Guidant Corporation™s implanted automatic defibrillator was halted because the device reduced by 20 percent the chance of death for patients with previous heart attacks. The Multi-center Automatic Defibrillator Implantation Trial (MADIT II) involving 1,200 patients at 71 centers in the United States and five centers in Europe was terminated early after an independent board observed that heart attack survivors receiving the company's implanted defibrillator experienced substantially reduced mortality from sudden cardiac death (SCD). MADIT II is a landmark study that demonstrates the further benefit of implantable therapy. Previous trials, including MADIT, MUSTT and AVID, have demonstrated that implantable defibrillators improve survival in other patients populations. In this study, implantable defibrillators reduced mortality by 30 percent, said Dr. Arthur J. Moss, principal investigator. Spectranetics Concludes LARS Trial The Spectranetics Corporation is concluding its LARS (Laser Angioplasty for Restenosed Stents) trial at 138 patients in light of Spectranetics' recent approval from the FDA to market its products to clear out restenosed coronary stents prior to brachytherapy treatment. Spectranetics will continue to follow all 138 LARS patients through the study's nine-month follow-up period. The company™s clinical priorities for 2002 continue to place top priority on accelerating the PELA and LACI clinical trials involving the use of excimer laser energy to clear blockages in the arteries of the legs. CardioVasc Receives CE Mark for NuVasc Stent Graft CardioVasc Inc. has received a CE Mark approval for its NuVasc Stent Graft. The company said its technology platform incorporates patented material surface strategies that bond various compounds and drugs to the device in order to reduce vessel inflammation and reduce restenosis. An ePTFE sleeve treated with P-15, a patented cell adhesion peptide coating, covers the stent and serves to protect the plaque material from releasing into the bloodstream. P-15, developed by researchers at the University of California-San Francisco, promotes rapid endothelial cell growth on artificial surfaces. These innovations should serve to lower restenosis and thrombosis rates after the diseased vessel has been treated. CardioVasc said interventional cardiologists will use the NuVasc Stent Graft to treat saphenous vein grafts that have failed after heart bypass surgery. More than 500,000 such operations take place worldwide each year with graft failure rates of more than 10 percent in the first year and 50 percent at 10 years. Conventional PTCA and techniques have been shown to have high complication and high restenosis rates. Complications after repeat surgery are two to four times the original surgery. This new device can treat a patient pool in excess of 1,000,000 patients. Three Genes Linked to Premature Heart Disease Scientists say they have found evidence linking three genes to premature heart disease in what could be a step toward a better screening procedure for families at risk. Using a new technique called high throughput microarray genotyping to sift through some 50,000 genes, the researchers found that three produce thrombospondin. The protein governs blood™s ability to clot. The study found that families with a variant of a gene called thrombospondin-4 were 89 percent more likely to have a premature heart attack compared with those who had a normal gene of the same type. Researchers also found that a variant of the gene thrombospondin-1 was 10 times more likely to form blood clots, while a variant of another gene thrombospondin-2 actually reduced the risk of heart attack by 69 percent. Dr. Eric Topol, the study™s author and a Chairman of Cardiovascular Medicine at the Cleveland Clinic Foundation, said the study was just a first step in the quest to find the root causes of heart disease. The hunt for the genes to explain this disease has actually not gone too far yet, Topol said. We know there™s something going on. Each of these variants are making very abnormal proteins. Topol said the research could lead to a screening procedure to identify at-risk families at an early age. He said the next step is for others to replicate his findings and show the cause-and-effect relationship between the suspect genes and heart illness. Experts said the study suggested that researchers were on the right track. There are millions of segments of genes. This is just one segment, said Dr. David Fischman, a cardiologist and an assistant professor of medicine at the Thomas Jefferson Medical College in Philadelphia. He said research is farther along on genetic markers that could predict cancer risks. Fischman predicted ethical battles over whether to manipulate genetic codes in an effort to stop diseases. Unique Reimbursement Code and Medicare Payment Amount for Microvolt T-Wave Alternans Cambridge Heart, Inc. announced that a Current Procedural Terminology (CPT) code with a specific Medicare payment amount for its Microvolt T-Wave Alternans testing has been published in the Federal Register. Effective January 1, 2002, CPT code 93025 may be billed electronically. The national Medicare payment amount for the test will be $263.53. The code is unique to Microvolt T-Wave Alternans and may be used alone or in conjunction with other diagnostic cardiovascular tests when submitting for reimbursement of claims to either Medicare or private insurers. For the first time, providers will be able to file for reimbursement of a Microvolt T-Wave Alternans Test electronically and be confident of the amount of payment. New Biotronik Pacemakers Implanted Biotronik Inc.™s new pacemaker with Home Monitoring Technology was successfully implanted in patients in California and Washington after the device received FDA clearance. Biotronik said its system is the first medical implant capable of remote, real time monitoring. The device uses cell phone signals to beam information directly from the pacemaker to the doctor's office without the patient taking any special steps. With Home Patient Monitoring, the pacemaker can be customized to automatically transmit a detailed cardio report to the physician's office on a daily or weekly basis and if the patient experiences a significant change in their heart condition. The continuous monitoring is anticipated to allow the patient's clinician to be able to respond quickly and efficiently to the patient™s changing cardiac status. ELUTES Study Confirms Positive Results of Higher Dosage Paclitaxel-Coated Coronary Stents In Inhibiting Restenosis Data from the 192-patient ELUTES dose-ranging study of drug-eluting coronary stents in Europe confirmed the positive results of cytostatic, higher dosages of paclitaxel in reducing restenosis, researchers announced at the American Heart Association™s Scientific Sessions. The ELUTES study, sponsored by Cook Incorporated and presented by principal investigator Anthony Gershlick, MD, reported a 3.1 percent rate of binary restenosis within the stented region in the highest dose arm of 37 patients who received coronary stents coated with a 2.7 mcg/mm2 dose of paclitaxel. The binary restenosis rate compares very favorably to the four percent rate of restenosis found in the 3.1 mcg/mm2 arm of Cook™s ASPECT trial, explained John DeFord, PhD, president and chief executive officer of Cook Incorporated. Cook™s strategy from the beginning was to use the ASPECT and ELUTES trials to identify the dose of paclitaxel with the most positive response in inhibiting restenosis. These results confirm our earlier study that a dose in the range of 3 mcg/mm2 delivers a clinically significant reduction in restenosis without contributing to MACE rates. This study provides further support for our U.S.-based PATENCY trial using the 3 mcg/mm2 dose found to produce the strongest clinical outcomes. The ELUTES (EvaLUation of pacliTaxel-Eluting Stent) trial evaluated the safety and efficacy of four different doses of paclitaxel compared to an uncoated Cook V-Flex Plus stent. This randomized, prospective dose-ranging study included dosages of 0.2 mcg/mm2; 0.7 mcg/mm2; 1.4 mcg/mm2 and 2.7 mcg/mm2. Patients were evaluated at six months using angiography, analyzed by an independent core angiographic laboratory, to determine the effectiveness of each dose of paclitaxel in reducing the rate of restenosis in patients with de novo lesions undergoing coronary artery angioplasty and stenting. The rate of binary restenosis within the stented region was reduced significantly in this study from 20.6 percent in the control arm to only 3.1 percent in the highest dose arm due to paclitaxel™s cytostatic mechanism of action in inhibiting neointimal hyperplasia. Mean diameter stenosis was reduced from 33.9 percent in the control group to 14.2 percent in the highest dose arm. In the highest dose arm, 89 percent of patients were free of major adverse coronary events (MACE) at six months, and there was no significant difference in MACE-free survival between the higher dose arm and patients in the control arm at one month and six months. The trial™s MACE rate was adjudicated by an independent clinical events committee. The ELUTES study data will be used by Cook in its submission for CE Mark approval to market a paclitaxel-coated coronary stent based on its V-Flex Plus stent design in the European Community. Approval is anticipated in the second quarter of 2002. Siemens Announces New biograph Series LSO The Nuclear Medicine Group of Siemens Medical Solutions announces its new biograph LSO (lutetium orthosilicate) molecular imaging system, a new addition to the biograph series product line. The biograph LSO combines integrated PET and computed tomography (CT) technology with new, patented high-speed LSO based detectors. biograph, the world's first commercial PET/CT imaging scanner, makes it possible to collect and correlate both anatomical and biological information into a fused image during a single, noninvasive examination. It was selected by Time® Magazine as one of its Inventions of the Year for 2000. The patented high-speed LSO (lutetium orthosilicate) detector crystals reduce whole body PET scanning time by half, while maintaining image quality in both oncology ansd cardiology applications. LSO, a proprietary detector scintillator material with significant high-energy imaging characteristics, improves light output and reduces light decay time within the crystal, making it an ideal PET scintillator. Cordis' CYPHER Sirolimus-Eluting Stent Shows Promise Against In-Stent Restenosis in Patients with Coronary Artery Disease Pilot clinical results show the potential for Cordis Corporation's CYPHER Sirolimus-eluting Stent to markedly reduce in-stent restenosis in patients with coronary artery disease.Funded by a grant from Cordis, the ISR (In-Stent Restenosis) study was the first-in-man clinical research to examine the value of the company's Sirolimus-eluting investigative stent in treating in-stent restenosis. We recently reported data from the RAVEL clinical study showing virtually no late loss and zero restenosis in previously untreated, or de novo, lesions six months following placement of the CYPHER Sirolimus-eluting Stent, said Prof. J. Eduardo Sousa, M.D., Ph.D., Co-principal Investigator, and Professor of Interventional Cardiology at Dante Pazzanese Institute of Cardiology, Sao Paulo, Brazil. Now we have evidence this stent may show a similar effect in preventing reblockages in previously stented arteries, he said. According to Dr. Sousa, results from the study indicate extremely low in-stent late loss (0.08 mm in minimum lumen diameter) at four-month follow-up in the 25 ISR patients treated at his hospital center. In-stent late loss is a sensitive and specific measure of the amount of tissue proliferation that can result in reblockage of the vessel. Additionally, the study's results show 0.0% restenosis, 0.0% TLR (target lesion revascularization), no thrombosis, and no deaths. The reference vessel diameter was 2.8 mm, with a mean diameter stenosis of 7.7%. Results were documented using intravenous ultrasound (IVUS) and quantitative coronary angiography evaluated by independent Core Laboratories. We were particularly impressed by the efficacy of the CYPHER Sirolimus-eluting Stent against a wide variety of restenotic lesions, said Dr. Sousa. Cell Transplants Used to Repair Heart Muscle Damage Early human trials of heart-failure treatments that use muscle and bone marrow cells taken from other parts of the body to renew tissue could mark a new direction for cardiology. We are really in the infancy of these techniques. This is like the first balloon angioplasty procedure, said Dr. Patrick Serruys of the Thorax Center in Rotterdam, the Netherlands. Serruys was the lead investigator in the first human trial using muscle cells, called myoblasts, taken from a patient's thigh to regenerate scarred heart tissue. The trial was sponsored by privately held Bioheart Inc. of Fort Lauderdale, Florida, which has a patent on the cellular process. We have demonstrated that it is possible to coax the human heart to regenerate damaged tissue, improve its functional capacity, and restore a better quality of life for the patient, Serruys said. The investigator said his team harvested muscle cells from a 78-year-old woman with a history of coronary artery disease and a heart attack that cut the organ's pumping efficiency to 39 percent, grew the cells in a culture and injected them into the damaged region of the patient™s heart through a catheter. Radiance Performs First Beta Radiation Treatment of Peripheral Vessels in U.S. Radiance Medical Systems, Inc., has enrolled the first U.S. patients in their peripheral vascular clinical study, RAPID (Radiation After PTCA Is Done). The three de novo lesion cases were completed at Rush Presbyterian Hospital, Chicago, and all involved the beta irradiation of a portion of the superficial femoral artery (SFA). The patients were treated using Radiance™s RDX® System by interventional cardiologists from Rush Presbyterian Hospital, Dr. Gary Schaer, Dr. Jeff Snell and Dr. Cliff Kavinsky. Dr. Maurice Buchbinder, Director of Interventional Cardiology at Scripps Memorial Hospital, La Jolla, Ca., and Radiance™s Medical Director, assisted. Radiance believes this was the first use in the United States of beta radiation to treat arterial stenosis in a peripheral vessel. Including European centers, a total of 14 patients have been treated under the RAPID protocol. Study: Gene Creates Healthy Capillary Growth A University of California, San Francisco-led team reported that a molecule known as HIF-1á could prove an effective target for inducing the growth of blood vessels in oxygen-starved tissues. The strategy is sought for treating cardiac and peripheral vascular disease, diabetes-damaged tissues and intractable wounds. The finding is a notable advance in an effort that has met with setbacks. Researchers have tried to generate the production of healthy blood vessels by inducing over-expression of the growth factor VEGF. But studies in mice have shown that while over-expression of VEGF induces the growth of blood vessels, the capillaries are leaky, the tissues are inflamed and swollen, and the blood vessels have an abnormal, corkscrew-like shape. In the current study, researchers genetically engineered mice to overexpress the HIF-1á gene in skin cells. In response, the number of capillaries in the mice's skin increased by nearly 70 percent. The blood vessels did not leak, or cause swelling or inflammation. The increase in healthy blood vessels was evident in the mice's significantly pinker ears, paws and tails. The vessels looked like normal capillaries, said Dr. Jeffrey M. Arbeit, senior researcher. This finding, together with the fact that the vessels didn™t leak, is extremely exciting. The overexpression of the HIF-1á gene caused a 13-fold increase in the expression of the VEGF gene. The fact that HIF-1á had an effect on VEGF expression is not surprising in itself, as HIF-1á is a sub unit of the HIF-1 transcription factor, which regulates the expression of numerous genes, including VEGF. However, the finding does prompt the question of why the blood vessels were robust, given that previous studies involving elevated expression of VEFG led to the development of weak, leaky vessels. We know that VEGF plays a crucial role in blood vessel growth. We need to determine how overexpression of HIF-1á harnesses VEGF in a way that could be beneficial therapeutically, said David Elson, staff research associate in the Arbeit lab. The HIF-1á gene is already being explored as a stimulant to promote blood vessel growth in oxygen-deprived tissue such as that associated with diabetic peripheral vascular disease, which can cause chronic leg ulcers that often precipitate amputation. It is being investigated as therapy to increase blood flow into cardiac tissue deprived of oxygen due to clogged arteries, and as therapy to treat recalcitrant wounds resulting from lack of blood flow to the legs caused by atherosclerosis alone or in association with diabetes. It could also be used to promote the grafting of artificial skin into tissues of the body, either in burn or diabetic patients. Once a graft had fused with the skin, the gene could be turned off. On the flip side, HIF-1á could prove a potent target for cancer therapy. Malignant tumors must recruit blood vessels to fuel their growth. Scientists have known that HIF-1á is over-expressed by malignant tumors, and NIH investigators currently are exploring its potential as a therapeutic target. However, the gene's specific role in cancer development has not been known. The discovery that overexpression of the gene generates the growth of robust blood vessels will assist ongoing therapeutic studies. The current finding leads scientists closer to teasing out the specific role of HIF-1á. The HIF-1 transcription factor regulates the activity of numerous genes, some of which promote blood vessel growth in response to oxygen deprivation. And scientists have known that the HIF-1á gene, a sub unit of the transcription factor, activates genes required for energy metabolism and tissue perfusion during periods of oxygen deprivation and is necessary for embryonic development. They have also known that the gene is over-expressed during myocardial infarction in wound healing and in malignant tumors. But its specific role in these conditions has not been known. Once expressed, HIF-1á is swiftly degraded at the protein level in healthy adult cells. The study was funded by the National Institutes of Health. FDA Approves XMI Catheter for Coronary Indications The U.S. FDA has given clearance for Possis Medical Inc.™s 4 French XMI catheter to be labeled for removing blood clots from native coronary arteries and coronary bypass grafts in the United States. It was released in April 2001 with labeling for the peripheral arterial market. The company also announced receipt of a new Current Procedural Terminology (CPT) code for Medicare coronary reimbursement, which reimburses physician time employed in using the AngioJet® Rheolytic Thrombectomy System during a coronary angioplasty. This additional reimbursement amount, which is estimated to be $174.48 on a national average, becomes effective January 1, 2002. The FDA approval of the XMI catheter for coronary use, along with the new CPT code, will allow the Company to begin focused marketing efforts to complete adoption of this catheter model in its intended coronary market. First U.S. Implant of Next-Generation Lifepath AAA Endovascular Graft Edwards Lifesciences Corporation announced the first U.S. implant of its next-generation bifurcated Lifepath AAA Endovascular Graft as part of the company™s Phase II clinical study. The Lifepath AAA system is a less-invasive option for treating abdominal aortic aneurysms (AAA), a potentially life-threatening condition that involves a weakening and ballooning of the wall of the aorta, the body™s main circulatory channel. The implant occurred in a 69-year-old male patient at the Jobst Vascular Center in Toledo, Ohio. The procedure follows the U.S. Food and Drug Administration's recent approval for Edwards to resume enrollment in its clinical study of the device. Dr. Hugh G. Beebe, director of the Jobst Vascular Center and clinical professor of surgery at the University of Michigan Medical School, said, The procedure went very smoothly, with the patient recovering quickly. NMT Medical Receives PMA Approval for CardioSEAL® Cardiac Septal Repair Implant NMT Medical, Inc. has received pre-market approval (PMA) from the U.S. FDA allowing commercial sale of the Company™s CardioSEAL cardiac septal repair implant in the United States for patients with ventricular septal defects (VSD) that are not candidates for surgical closure. The CardioSEAL implant is placed in a minimally invasive, catheter-based procedure in the cardiac catherization laboratory. The company has obtained CE Mark approval for CardioSEAL and the next generation STARFlex® implants for atrial level defects. CryoCath Announces First Human Clinical Use of Arctic Circler to Treat Atrial Fibrillation CryoCath Technologies Inc.™s 7F Arctic Circler Cryoablation System was used on December 4, 2001, to treat a 63-year-old man with Atrial Fibrillation at University Hospital in London, Ontario, Canada. The procedure, which holds the promise of making AF ablation quicker to perform and more effective, was carried out under the supervision of Dr. Allan Skanes. We were able to navigate the device within the left atrium, and to ablate and isolate acutely the three targeted pulmonary veins with relative ease and precision. Based on the ease-of-use demonstrated in the December 4th trial, it is expected that the ablation time required for a procedure to treat AF may be reduced to under two hours. This duration compares favorably to ablation times using heat-based technologies that can often take up to four to five

NULL