CDU Washington Editor

WASHINGTON Stents, stents and more stents.

Despite a clear effort by conference organizers to embrace presentations on new resynchronization/pacing technologies and other interventional technology developments, the annual Transcatheter Cardiovascular Therapeutics (TCT) Symposium held here in mid-September served as a clear demonstration that stents specifically the new generation of drug-eluting models are a dominant discussion topic, both among clinicians and an industry that is embracing drug-coated implants as The Next Big Thing in medical technology.

Senior management at Cordis (Miami Lakes, Florida) decided not to take any chances by resting on the company's laurels as maker of the first FDA-approved drug-eluting stent in the U.S., but instead rolled out new data for the Cypher sirolimus-eluting stent before the TCT conference officially began. In a press briefing held the day prior to the opening of the TCT conference, Cordis set the stage for what promises to be a competitive market when Boston Scientific (Natick, Massachusetts), expected to be the next in line, gains approval for its Taxus stent.

Being first to gain FDA approval has proven beneficial for Cordis, a Johnson & Johnson (New Brunswick, New Jersey) company, which has 60% of the worldwide market in drug-eluting stents (DES) based on dollar value share, according to Sam Liang, vice president of global stent franchises for Cordis. "We originally stated that supply of the Cypher stent would be constrained through September of 2003, and as of today, there are no U.S. order restrictions or back orders. We have increased allocation from 50% to 70% on all orders, and now operate at 100% capacity for U.S. orders," Liang said. Cordis, however, does have instances of backorders in some of the 80 countries where the device is approved, he said. The Cypher stent has been implanted in more than 200,000 patients worldwide since it was first approved, he added.

Despite the manufacturing difficulties, Cordis plans to introduce a longer drug-eluting stent ahead of schedule, noted Liang. "We anticipate an early launch of the 3.5mm stent and plan on introducing the next-generation stent to the FDA for approval." The company's next-generation Cypher Select stent offers an improved delivery system for sirolimus, as well as adjusted geometrical calculations for greater flexibility, Liang said. "It will be more flexible and give physicians greater control over placement of the stent," he added.

The biggest news Cordis had to share on the eve of TCT dealt with the latest clinical results of Cypher. Data from Canada and Europe demonstrate restenosis rates of 5.1%, which surpass those of the original SIRIUS trial in the U.S., Liang said.

The new results demonstrate that the stent can perform equally well in patients with small vessels and long lesions, as well as smokers and patients with previous heart attacks, said Martin Leon, MD, chairman of the Cardiovascular Research Foundation (New York), which sponsors TCT. Leon also serves as senior attending physician and interventional cardiologist at Lenox Hill Hospital (New York) and was co-principal investigator in the original SIRIUS clinical trial. "The results from the latest data show that drug-eluting stents aren't just a minor, irritable change in treatment but a revolutionary alternative. Achieving single-digit restenosis rates is almost unimaginable and will usher in an era of less-invasive treatment that will be used more often and earlier," Leon told reporters. NEW SIRIUS represented 225 patients whose previously untreated coronary blockages were treated with a Cypher stent. In addition to patients with small vessels and longer lesions, multiple stents and overlapping stents were also common among the patients, Liang said.

The biggest obstacle for physicians in gaining confidence with drug-eluting stents is education and advice on how the newer devices work in patients, said Leon. "The decrease in restenosis demonstrates the value of the device, but how the device is used can play a vital role in the patient's outcome," he explained. "The most significant lesson we've learned is that you can't treat a drug-eluting stent as you would a bare stent. You need to be cautious with both pre- and post-dilitation and pay meticulous attention to placing the stent so that you get the optimal performance out of it. And it's up to the physician to get the optimal performance out of the stent," Leon advised.

TAXUS results also show strength

Sunday of TCT week may have been Cordis' day to shine, but the next day clearly belonged to Boston Scientific (Natick, Massachusetts). The pre-TCT salvo from Cordis was answered by Boston Scientific with the release of early results from its TAXUS IV clinical trial. The Taxus Express stent showed target vessel revascularization (TVR) occurrence the primary endpoint at 4.7% compared to 12.8% for the control, which was a bare-metal stent. Of the 1,326 patients enrolled in the trial, 1,314 were implanted with stents. Stent lengths used were 16 mm, 24 mm and 32 mm lengths, and diameters were 2 mm 2.5 mm, 3 mm and 3.5 mm. A total of 76 sites in the U.S. were involved in the trial.

Leon said the trial, with the tongue-challenging name of Pivotal, Prospective, Randomized Trial of the Slow-rate Release Polymer-based Paclitaxel-Eluting Taxus stent, promised to reveal the "most exciting" results ever presented at TCT.

"Restenosis has been the Achilles heel of percutaneous coronary angioplasty," said Gregg Stone, MD, director of cardiovascular research and education at Lenox Hill Heart & Vascular Institute (New York) and principal investigator of the TAXUS IV trial. "This was a totally blind trial in that physicians didn't know if they were implanting a paclitaxel stent or bare-metal stent. The stents are identified through a serial number, and patients will not know if they have the coated or bare stent until the five-year follow-up is complete," he said.

Target lesion revascularization in the Taxus stents was 3%, compared to 11.3% for bare stents. Nine-month major adverse cardiac events was 15% in the control group compared to 8.5% in the Taxus group, and no significant differences were reported in stent thrombosis between groups. "The take-home message from the trial is that the Taxus stent is effective for a variety of hard-to-treat patients, including those with small vessels, long lesions and patients with diabetes," Stone said. Boston Scientific is expected to be the second firm to get FDA approval for commercialization of a DES in the U.S., with that nod anticipated by year-end or early in 2004.

Guidant seeks to get in hunt

Six-month findings from the FUTURE II trial, as well as preliminary 12-month data from its predecessor, the FUTURE I trial, confirm the safety and performance of a drug-eluting stent using everolimus as the drug of choice. FUTURE I and FUTURE II use the Champion stent, manufactured by Guidant (Indianapolis, Indiana), sponsor of both trials. Guidant has been seen as badly trailing drug-eluting stent market leaders Cordis and Boston Scientific.

Findings from the pair of FUTURE trials were presented at TCT by Eberhard Grube, MD, chief of the department of cardiology and angiology at the Heart Center Siegburg (Siegburg, Germany) and principal investigator of the trials. "The biggest difference in FUTURE II from its predecessor is that it includes more high-risk patients, including diabetics," said Grube to the thousands of physician attendees at the TCT session. Similar stents were used in both trials. Both 14 mm and 18 mm lengths were used, ranging in diameter from 2.5 mm to 4 mm. Conclusions from the FUTURE I trial include no subacute thrombosis in either the control or drug-eluting stent group, Grube noted. Additionally, he reported that the DES group showed significant reductions of in-stent tissue proliferation at the six-month follow-up.

"Angiographic in-stent late loss was reduced by 87% to 0.11 mm, and the intravascular ultrasound neointimal volume was reduced by 87%. There was no percentage of angiographic in-stent binary restenosis in the everolimus eluting stent group," he explained. There were no major adverse cardiac events (MACE) reported between six and 12 months for the FUTURE I patients, Grube said. In terms of sustained safety, researchers found no incidences of aneurysms or stent malapposition, he added. The minimal lumen area was sustained at the 12-month follow-up, as well as the luminal volume index. Most importantly, there was no incidence of in-stent binary restenosis at 12 months, according to Grube.

Clinical follow-up of patients in the FUTURE II show similar results. In the everolimus stent group, only one adverse event occurred at six months and was due to a proximal edge restenosis, Grube said. A total of seven patients had adverse events with the metal stent. Three cases were due to edge restenosis, he added. Overall MACE rates for the everolimus stent group at six months were 4.8%. The everolimus stent had excellent acute results in performance during the first 30 days, Grube said. "There was no MACE, and the procedural and clinical success rates were both 100%," he noted.

The stent showed significant reduction of in-stent tissue proliferation at the six-month period as well. Angiographic in-stent late loss was reduced by 86%, and in intravascular ultrasound neointimal volume was reduced by 95%. There was no in-stent binary restenosis in the everolimus stent arm, Grube said.

Guidant filed its submission in August to European regulatory authorities for the Champion stent and its bioabsorbable polymer delivery system with everolimus. "Publicly, we aren't counting on getting the CE mark as of yet, but we are anticipating an FDA approval in late 2005 or early 2006," said Dana Mead Jr., president of vascular intervention at Guidant. "We haven't named the trial we'll conduct here in the U.S. yet, but will make the information public in the first quarter of the fiscal year, probably sometime in early November," he added.

Guidant will use the same drug/polymer concentrations that were used in the FUTURE II trial and will use its own Vision stent for the control group, Mead said. "Guidant will leverage these data as we move forward with regulatory filings and subsequent clinical studies," he noted.

Medtronic unveils data for cobalt stent alloy

Although only four months old, preliminary data from a clinical trial for a new non-stainless steel stent showed positive results at reducing restenosis and could set a benchmark for future drug-eluting stent studies. "Based on the robust patient size and the successful patient follow-up, this study could set the benchmark for future studies, particularly in post-procedure follow-up," Ian Meredith, MD, principal investigator of the Endeavor I clinical trial at Monash Medical Centre (Melbourne, Australia), told physicians attending the TCT symposium. Titled Endeavor I and sponsored by Medtronic Vascular (Santa Rosa, California), the study also has the distinction of being the first clinical trial using a non-stainless steel stent material. The stent itself, called Driver, is made of cobalt alloy and is considered the next generation for stent materials, Medtronic said.

Endeavor I, involving 100 patients from Australia and New Zealand and begun in January, is a prospective, multi-center trial assessing the safety and efficacy of the Endeavor drug-eluting stent for previously untreated lesions in coronary arteries with a diameter of 3 mm to 3.5 mm. "The initial four-month results of Endeavor I are very impressive and demonstrate that the Endeavor drug-eluting stent is meeting its clinical study goal of preventing restenosis," Meredith said. "The study's primary endpoints included a 1.0% [major adverse cardiac event] rate at 30 days and four-month late lumen loss of 2 mm in segment." He added: "These results, combined with the fact that there was a four-month 2.1% binary restenosis rate and a four-month total lesion revascularization rate of 1%, shows that the Endeavor stent used in the trial brings a complementary combination of drug, stent and polymer together to produce compelling results." Finally, he said, "the extensive [intravascular ultrasound] follow-up in this trial shows excellent lumen preservation from beginning to end, with only 4.5% neointimal volume loss."

The Endeavor stent uses the drug ABT-578, a patented compound cross-licensed by Medtronic from Abbott Laboratories (Abbott Park, Illinois). The drug inhibits smooth muscle cell growth by blocking the function of the cell cycle regulatory protein. Smooth muscle cell growth is considered a key factor in restenosis of arteries. Medtronic received FDA approval of the Driver stent in October, but is still awaiting clearance of ABT-578l.

"The advantage of the Driver is that it is comprised of smaller struts, has increased flexibility and greater deliverability of the drug. It also maintains 100% rigidity during delivery, which makes it easier for physicians to use," Meredith said. The Endeavor I trial's design using a four-month follow-up period was chosen because restenosis tends to occur later following placement of a stent, he said. "This trial, with 100% of the patients coming back for post-procedure follow-up, gives the data even more credibility," the Australian physician added. "Usually, only 80% of clinical trial patients may show up for follow-up, which means only 80% of those patients are evaluable, but when you have all patients return, you have better data," he said.

"The Endeavor I data fully met our expectations and provides a solid foundation for the Endeavor II clinical trial which just got under way," said Bill Hawkins, president of Medtronic Vascular, during a press briefing at TCT. "The Endeavor drug-eluting stent performed exactly as we believed it would and reinforced our belief that the various components of our program would come together to provide a compelling drug-eluting stent system," he added. "We are on schedule with Endeavor II, and we are pleased that the Endeavor stent achieved this milestone with such excellent results."

"There are advantages to being late in the market," Hawkins told investors attending a Medtronic-sponsored investors meeting at which it outlined its strategy for the coming years as it breaks into the DES market. "Our balloon delivery technology is better, the performance of the stent is exceeding expectations, and it shows promise in treating all sizes of lesions." Competition and particularly gaining market share in the DES market will focus on deliverability of the drugs, Hawkins said. "That's where we have an advantage."

The Endeavor I results seem to confirm a collective perception among cardiologists that some drugs perform better than others at inhibiting cell growth, according to Meredith. "There is a perception among most that some drugs perform better than paclitaxel," Meredith told investors and physicians at the briefing.

The sentiment was echoed by Jeffrey Popma, MD, director of interventional cardiology at Brigham & Women's Hospital (Boston, Massachusetts). "This is not only a good drug, but it's evenly distributed on the stent and has a better platform," he said.

Medtronic plans to start enrollment for Endeavor III in the spring of 2004, according to Sara Toyloy, vice president of clinical research and regulatory affairs. "We plan to complete enrollment of Endeavor II later this year and get CE approval in late 2004, with FDA approval in late 2005," she added.

Plans for expanded staff and operations will begin soon in Ireland, where Medtronic is manufacturing the Driver stent, Hawkins noted. "We're not ready to discuss pricing for the U.S. yet, but we are gaining market share in Europe, and we're putting all our emphasis behind it," he said.

Endeavor III, with enrollment limited to the U.S., will be an equivalency trial to prove the device's performance domestically, Hawkins said. "The FDA wants us to prove that it's as effective here in the U.S. as it is for other people worldwide."

The plan, according to Hawkins, is to use the Endeavor III trial as a head-to-head comparison of the Cypher stent from Cordis.

HEALING stent trial begins

Orbus Medical Technologies (Fort Lauderdale, Florida) said during TCT that it had started its Healthy Endothelial Accelerated Lining Inhibits Neointimal Growth (HEALING) clinical program with what it called the world's first bio-engineered coronary stent to inhibit restenosis and thrombosis.

HEALING I is the first of a series of trials in the Orbus program. It is designed to establish safety and assess healing responses. The first 10 patients of HEALING I represent the first-in-man portion of the trial. Enrollment has already begun at Erasmus University Medical Center's Thorax Center (Rotterdam, the Netherlands), led by principal investigator Patrick Serruys, MD, PhD, chief of interventional cardiology. The company intends to expand the trial to include 30 to 40 patients. End points of the trial include 30-day major adverse cardiac and cerebral events as well as six-month angiographic restenosis and IVUS volumetric analysis.

The HEALING program will be a series of studies to collect clinical information on Orbus' R stent with Genous Bio-engineered Surface. According to the company, this device has the potential to vastly improve the lives of people suffering from cardiovascular disease through the use of coronary stents and other cardiovascular applications that include peripheral stents, artificial vascular grafts, and heart valves.

A live HEALING I implantation of the system was performed at Erasmus University Medical Center and was televised live via satellite conferencing technology to the TCT conference. An 82-year-old male patient with a 73% calcified stenosis in his left coronary artery was successfully treated with a 3.5 mm x 18 mm Genous R stent.

The second trial in the HEALING program, HEALING II, is a study to collect data that will support CE mark registration and will be initiated toward the end of this year. Orbus said it anticipates starting HEALING III in the U.S. with a vastly expanded patient cohort in mid-to-late 2004 to support regulatory filings for U.S. commercialization.

Carotid stenting as effective as surgery

The benefits of the stent got a further boost with promising results for their use in the treatment of stroke. Researchers presented findings showing that carotid artery stenting (CAS) is as safe and effective as the current procedure carotid endarterectomy (CEA) in treating high-risk surgical patients. Patients who have already suffered a stroke or those with narrowed or blocked arteries are considered high risk. CEA is usually performed in patients with a 70% or greater reduction in the diameter of the carotid artery. From 20% to 30% of strokes are caused by particles of atherosclerotic plaque, known as emboli, traveling through the carotid artery to vessels in the brain, according to the American Heart Association (AHA; Dallas, Texas). Stroke is the No. 3 cause of death and the leading cause of disability in the U.S., according to AHA. About 700,000 strokes are reported annually in the U.S., accounting for about 168,000 deaths, the organization said.

One-year findings from the Stenting and Angioplasty with Protection in Patients at High Risk for Endarterectomy (SAPPHIRE) study suggest that patients with coexisting coronary artery disease and other cardiac conditions are good candidates for CAS. "Results of our clinical study indicate carotid stenting is an excellent option for patients with coronary artery disease, congestive heart failure and other co-morbidities that make them high-risk candidates for endarterectomy," said Jay Yadav, MD, principal investigator for the SAPPHIRE trial.

Yadav, who is director of vascular intervention in the department of cardiovascular medicine at the Cleveland Clinic Foundation (Cleveland, Ohio), said, "Stented patients are now 12 months out from treatment, and their adverse event rates continue to be as good as, and in many ways better than, those for the surgically treated group." Major adverse events, such as death, stroke or myocardial infarction up to 30 days following treatment, and death or stroke 31 to 360 days following treatment, are the major endpoints to assess the results in treating carotid artery disease, he added.

While promising for patients, the news is even better for study sponsor Cordis, the manufacturer of the Precise nitinol self-expanding stent. The stent, implanted in a total of 151 patients, was used in conjunction with Cordis' investigational device, the Angioguard XP emboli capture guidewire. Patients treated with the stent and embolic capturing guidewire had a major adverse event rate of 11.9% compared to 19.9% of the patients undergoing endarterectomy. Other endpoints showed comparable or better results: death, 6.9% vs. 12.6%; stroke, 5.7% vs. 7.3%; and myocardial infarction, 2.5% vs. 7.9%.

The success rate for delivering and retrieving the Angioguard device was 95.6%, Yadav said. Examination following the procedure showed debris in more than 60% of the baskets, he added. "Particulate debris can lead to a stroke. Thus, it's extremely important to capture the material and remove it from the bloodstream," he said.

"Thousands of patients with carotid artery disease are poor candidates for surgery," said Dennis Donohoe, MD, vice president of therapeutics and clinical research at Cordis. "We need to be able to offer them a safe, effective treatment alternative. The SAPPHIRE study results suggest we are moving rapidly toward that goal."

In another carotid stenting presentation, preliminary results from the SECuRITY trial reported during a late-breaking clinical trials sessions at TCT revealed that carotid stenting with a distal embolic protection device can be performed safely and is effective for treatment of critical carotid stenosis in a high-risk surgical population. In addition, major adverse events were approximately 7% for stenting with an embolic protection device, which is lower than historical rates in patients with high risk for CEA.

Patrick Whitlow, MD, director of interventional cardiology at the Cleveland Clinic Foundation (Cleveland, Ohio) and principal investigator of the SECuRITY trial, said the early SECuRITY data are "very encouraging." Noting that many patients with carotid disease do not respond well to either of the two current treatment options drug therapy or high-risk surgery he said that "based on this early data, we anticipate being able to offer patients a minimally invasive, effective alternative."

SECuRITY is a registry of high-risk patients utilizing the MedNova EmboShield bare-wire filter and MedNova Xact self-expanding carotid stent system from MedNova (Galway, Ireland). The trial was designed to evaluate the safety and efficacy of the filter-stent combination as a minimally invasive option for treating carotid artery disease in patients considered at high risk for surgery. Thirty-day data from the multi- center trial, which reported on 305 high-risk patients at 30 sites, showed that the study population's MAE rate was 7.2%. For this study, an MAE was defined as a stroke, death or myocardial infarction. The success of the Xact carotid stent (96%) was defined as successful deployment of the stent with less than 50% residual stenosis, while the success of the EmboShield device (97.3%) was defined by the successful delivery and removal of the filter. All patients in the trial had at least one factor that made them high risk for the surgical procedure, and 28.2% of the registry's patients were 80 or older.

The trial was sponsored by Abbott Vascular Devices (Redwood City, California), the cardiovascular device franchise of Abbott Laboratories (Abbott Park, Illinois), which has an exclusive agreement with MedNova to distribute the EmboShield filter and Xact carotid stent products. "These promising results indicate that we may be one step closer to our goal of bringing a minimally invasive option to patients considered to be at high risk for surgery," said Donald Schwarten, MD, divisional vice president and medical director, Abbott Vascular Devices. "The EmboShield embolic protection filter and the Xact carotid stent may have the potential to change the way physicians approach and treat patients with carotid artery disease."

Jiri Vitek, MD, PhD, of Lenox Hill Heart and Vascular Institute, added that the EmboShield system "could have a significant impact for many patients for whom surgery would present high risk."

The EmboShield device and Xact carotid stent are currently distributed by Abbott throughout Europe, Canada, Latin America, Africa, the Asia-Pacific region and the Middle East. In addition to the SECuRITY trial, the EmboShield filter is currently under investigation in a global, randomized trial called CAPTIVE, which is studying the efficacy of the EmboShield filter in saphenous vein grafts.

Elsewhere at TCT

St. Jude Medical (St. Paul, Minnesota) reported during TCT that it had begun its global launch of the Angio-Seal STS Plus, its latest-generation vascular closure device. The Angio-Seal is the No. 1 vascular closure device used worldwide, according to St. Jude. The STS Plus offers enhancements to the Angio-Seal STS Platform, with more efficient device positioning, smoother arterial access and other new features. The device is offered in both 6 Fr and 8 Fr sizes and is indicated for use in closing femoral arterial puncture sites following diagnostic or interventional catheterization procedures. It builds on the STS Platform, which features a self-tightening suture that allows the arterial closure procedure to be completed in the cath lab.

"The introduction of our fifth-generation device, paired with clinical studies and FDA-approved labeling that supports earlier ambulation and discharge, helps clinicians to maximize the effectiveness of vascular closure while maintaining a foundation for safe, efficient patient treatment," said David Adinolfi, president of the Daig business of St. Jude. "Only 30% of catheterization procedures currently utilize closure devices, but the technology is rapidly becoming the standard of care in many hospitals around the world." The original Angio-Seal device, developed by Kensey Nash (Exton, Pennsylvania), with product rights later acquired by St. Jude, received FDA approval in September 1996.

NMT Medical (Boston, Massachusetts), a company developing and marketing catheter-based technologies for treating cardiac sources of stroke, had its CardioSEAL technology featured in the opening session of the TCT. A live case transmission from Lenox Hill Heart and Vascular Institute used a CardioSEAL implant to close a common heart defect called a patent foramen ovale (PFO), which is considered to be associated with a high risk for stroke in patients under 60 years of age. Robert Sommer, MD, assisted by Horst Sievert, MD, from Frankfurt, Germany, performed the 15-minute catheter-based procedure in the cardiac catherization lab at Lenox Hill on a 49-year-old female patient with a PFO who had had a recurrent stroke.

In addition to the live case, data from closing PFOs with the CardioSEAL technology was reported in three presentations by researchers from Cedars Sinai (Los Angeles, California), CVC (Frankfurt, Germany) and Emory University (Atlanta, Georgia).

Spectranetics (Colorado, Springs, Colorado) unveiled results from the CORAL LAKE registry, a single-center, retrospective registry that studied the use of its excimer laser for the treatment of degenerated saphenous vein grafts at the conference. The registry yielded an acute procedural success rate of 98% and an acute major adverse cardiac event (MACE) rate of 5%.

CORAL LAKE included 119 patients treated with the excimer laser at Lakeland Regional Medical Center (Lakeland, Florida), by Douglas Ebersole, MD, and other interventional cardiologists at the hospital. The goal of the registry was to quantify acute outcomes in saphenous vein grafts after excimer laser treatment, as evidenced by procedural success and MACE events. Procedural success was defined as having a final residual stenosis less than 50% of the original stenosis.

Randomized clinical trials have shown that treatment of saphenous vein grafts with traditional therapies such as balloons and stents result in 30-day MACE events approaching 20%. The 30-day MACE rate shown in randomized trials with traditional catheter-based therapies plus embolic protection devices has been reduced to approximately 10%. A key contributing factor to MACE events is distal embolization, or the dislodging of plaque, thrombus, or other atherosclerotic debris that can form blockages elsewhere in the vascular system.

"The findings of Dr. Ebersole's registry further supports our belief that the excimer laser can benefit patients with blocked bypass grafts," said John Schulte, president and chief executive officer of Spectranetics. "This is encouraging, as it supports our multi-center clinical registry that is already under way at 12 hospitals in the U.S. This larger CORAL [COronary graft Results following Atherectomy with Laser] registry is a 250-patient study that also will be documenting the ability of the excimer laser to successfully treat diseased saphenous vein grafts."

OmniSonics Medical Technologies (Wilmington, Massachusetts), reported results of a pre-clinical study demonstrating the safety of its acoustic energy technology when used on stented coronary arteries. Drs. Elazer Edelman and Adam Groothuis of Brigham and Women's Hospital tested the safety of the technology in coronary vessels in pigs implanted with stents. The data which indicate that the application of acoustic energy is safe and will not create adverse side effects when used in stented coronary arteries were presented by Groothuis during a session on "Innovative Devices and Futuristic Therapies."

OmniSonics' Resolution System, based on the firm's OmniWave Technology platform, is designed to treat occlusions that occur as a result of coronary artery disease, deep vein thrombosis and peripheral artery disease. The device consists of a thin titanium wire placed into a clogged artery or vein. It delivers low-power acoustic energy in all directions to dissolve blood clots into minute particles about the size of red blood cells.

Endologix (Irvine, California) said that preliminary findings from the first 154 patients enrolled in the pivotal trial for the PowerLink System, an endoluminal stent graft for the treatment of abdominal aortic aneurysms (AAA), were presented by Dr. Jeffrey Carpenter, professor of surgery at the University of Pennsylvania (Philadelphia, Pennsylvania). Data was presented on 154 patients monitored for a minimum of one year, 37 of whom were followed for up to two years. Endologix said the PowerLink was safely deployed in 151 patients (98%), with no device-related deaths during the perioperative period. No aneurysm ruptures, wire fractures or material failures associated with the PowerLink System were reported during the follow-up period. Carpenter said, "The results of the study show the PowerLink System ... can be deployed quickly with a high degree of success and minimal complications. I have been duly impressed with the low endoleak rate as well as with the durability of the stent."

Endologix President and Chief Executive Officer Paul McCormick said more than 1,400 implants have occurred worldwide, and "the preliminary U.S. clinical trial data provides additional supportive evidence in gaining acceptance of the PowerLink technology."

The company said it expects to submit the final module in its premarket approval submission to the FDA later this year and anticipates receiving U.S. marketing approval in the second half of 2004.

The REDUCE-III prospective, randomized, multicenter, 521-patient trial, led by Japanese cardiologist Takahiko Suzuki, MD, analyzed the benefits of utilizing the Cutting Balloon technology from Boston Scientific vs. traditional balloon angioplasty before stenting in patients undergoing percutaneous coronary intervention.

The study revealed that the restenosis rate in patients receiving the Cutting Balloon angioplasty prior to stenting was 11.8% compared to a restenosis rate of 19.1% in those patients receiving traditional balloon angioplasty. Suzuki said the results, combined with the high rate of procedural success, show that Cutting Balloon angioplasty prior to stenting is a feasible and safe strategy for the treatment of coronary lesions.