Spectranetics Receives FDA Clearance to Market Turbo-Booster
Expanded Labeling Allows for Treatment of All Blockages in Leg Arteries
Spectranetics Corporation has received clearance from the Food and Drug Administration (FDA) to market its Turbo-Booster product for the treatment of arterial stenoses and occlusions in the leg. This represents a broader indication for use as compared to current labeling of existing peripheral laser catheters. The Turbo-Booster functions as a guiding catheter, facilitating directed ablation of blockages in the main arteries at or above the knee. The Turbo-Booster, combined with Turbo elite laser catheters, allows for removal of large amounts of plaque material within the SFA and popliteal arteries.
The CELLO trial, conducted to provide data to FDA in support of the 510(k) premarket notifications for the Turbo-Booster clearance, is a prospective registry that enrolled 61 patients at 16 centers in the United States. The trial included patients with stenoses and occlusions that were greater than or equal to 70% and less than or equal to 100% of the vessel lumen within arteries 4 to 7 mm in diameter. Three independent core labs analyzed the angiographic, intravascular ultrasound and duplex ultrasound data from the trial. The primary endpoints of the trial were the achievement of a minimum 20% reduction in the percent diameter stenosis post-laser compared to pre-intervention and major adverse events. The reduction in percent diameter stenosis following the use of the Turbo-Booster was 35% and there were no major adverse events reported through 30 days following the procedure. As a result, the primary endpoints were met. Further data included in the FDA submission showed a significant improvement in Rutherford scores and health assessment questionnaires at 30 days compared to pre-procedure.
Spectranetics plans to initiate two clinical trials in 2007, one in the United States and one in Europe, to assess the effectiveness of the Turbo-Booster and existing peripheral atherectomy products for the treatment of in-stent restenosis.

ev3 and FoxHollow to Merge
ev3 Inc. and FoxHollow Technologies, Inc. announced a definitive agreement by which ev3 and FoxHollow will merge in a $780 million cash and stock transaction. Upon completion of the transaction, FoxHollow stockholders would own approximately 41 percent of the combined company, and ev3 stockholders would own approximately 59 percent. The company's combined product portfolio will include a broad spectrum of products to treat vascular disease in both the peripheral and neurovascular markets, including atherectomy and thrombectomy, PTA balloons, stents, embolic protection devices, infusion catheters/wires, embolic coils and liquid embolics. The combined company will have direct operations or independent distributor presence in over 60 countries with more than 1,500 employees. The transaction is expected to be completed in the fourth quarter of 2007.

Study Offers Accurate Estimates of Cancer Risk with Cardiac CT
A new study suggests that young patients, and especially young women, who undergo 64-slice computed tomography (CT) cardiac scans are at highest risk for developing cancer later in life in association with radiation exposure. The results offer the first tangible estimates of radiation-related cancer risk linked to the relatively new, popular and highly effective diagnostic technology, allowing for more informed decisions about its use, especially in younger patients.
The analysis found that lifetime attributable cancer risk associated with cardiac CT scan exposure varies widely depending on age, sex and scan protocol. The risk increases with combined cardiac and aortic scanning and decreases when, during the scan itself, the dose of radiation is lowered so it is generated only during specific segments of the cardiac cycle or the field of radiation is reduced in size. The results appear in the July 18 issue of the Journal of the American Medical Association.
With this new generation of CT machines, there is an assumption of cancer risk, but there is very little information available about what characteristics might influence that risk, said Dr. Sanjay Rajagopalan, John Wolfe Professor of medicine and radiology at the Ohio State University Medical Center and senior author of the study. There has been an explosive increase in the use of this test to look for blockages in arteries because it offers a fast, noninvasive diagnosis. With this widespread usage, we need to help patients make informed choices and also help physicians balance the benefits of determining the correct diagnosis with the risks of future cancer risk.
CT scans have been used to examine coronary arteries since 1998, but the 64-slice technology for cardiac scans has been available only since 2004.
Lifetime cancer risk in actual patients undergoing a cardiac CT would take years and years to study and could never be accurately traced to a single scan in a person's medical history. So researchers simulated varying levels of expected radiation exposure from a single scan, using a national cancer risk database that provides estimates based on data from atomic bomb survivor studies and medical and occupational radiation studies. The analysis is called the Biological Effects of Ionizing Radiation 7th Report (BEIR VII). The researchers estimated radiation dose to organs by modeling photon transport through male and female phantoms created by mathematical calculations.
Women were expected to be at higher risk for developing cancer because their tissue is more sensitive than men's to radiation and because their breast tissue falls within the area scanned in cardiac CT. Those characteristics, combined with age, suggest women's lifetime risk of developing cancer after a single, normal 64-slice cardiac CT scan ranges from 0.7 percent in 20-year-olds to 0.075 percent in 80-year-olds (1 in 1,338).
The leading cause of cancer in women from a single cardiac CT scan was breast cancer until age 32, after which lung cancer risk exceeds that of breast cancer risk.
In contrast, risks to men were considerably lower. The lifetime risk of developing cancer ranged from 0.15 percent in a 20-year-old man to 0.044 percent in an 80-year-old man.
A relative risk analysis suggests a 20-year-old woman has 23 times the risk of an 80-year-old man of developing cancer after a single normal cardiac CT scan. The good news is that few 20-year-old women experience blockages in their coronary arteries, Rajagopalan noted.
This just points to the need to consider the overall risk-benefit ratio for any given patient and carefully consider the reasons for doing a CT study. It's a very good test, and in many cases, the benefits of the correct diagnosis will offset any risks, he said.
The study showed that extending the scan to include the top of the aorta increases the lifetime attributable cancer risk by up to 46 percent in men and 28 percent in women, depending on age. The analysis also showed that reducing the amount of radiation generated in a single scan corresponded to lower cancer risk.
Inside the scanner, we can reduce the amount of radiation exposure by reducing the field to radiate only organs we want pictures of or to radiate only a single phase of the cardiac cycle. This technique should probably be employed more commonly than it currently is, Rajagopalan said.
For patients whose cancer risks outweigh potential benefits of a diagnostic cardiac CT, Rajagopalan suggests optional tests include a stress echocardiogram, a stress ultrasound or a magnetic resonance imaging test. He also noted that the 64-slice cardiac CT scan generates less radiation than commonly conducted nuclear studies of coronary arteries, such as dual isotope stress tests “ a fact he said is generally not acknowledged when discussing cancer risk associated with diagnostic heart exams.

Implantable Cardioverter-Defibrillators Appear Effective in Helping to Prevent Sudden Cardiac Death in Patients With Certain Heart Disorder
High-risk patients with hypertrophic cardiomyopathy (HCM) appear to have reduced risk of sudden cardiac death with an implantable cardioverter-defibrillator (ICD), according to a study in the July 25 issue of the Journal of the American Medical Association.
Barry J. Maron, MD, of the Minneapolis Heart Institute Foundation, Minneapolis, and colleagues examined the clinical risk profile and incidence and effectiveness of ICD intervention in patients with HCM. The researchers analyzed data from a multicenter registry of ICDs implanted between 1986 and 2003 in 506 patients with HCM, average age 42 years. Patients were judged to be at high risk for sudden death. Average follow-up was 3.7 years.
Risk factors analyzed included history of premature HCM-related sudden death in 1 or more first-degree or other relatives younger than 50 years; massive left ventricular hypertrophy; a certain type of nonsustained ventricular tachycardia; and prior unexplained syncope.
Twenty percent experienced 1 or more appropriate device interventions, in which the ICD terminated ventricular fibrillation or ventricular tachycardia. Intervention rates were 10.6 percent per year for secondary prevention after cardiac arrest (5-year cumulative probability, 39 percent), and 3.6 percent per year for primary prevention (5-year probability, 17 percent).
Time to first appropriate discharge was up to 10 years, with a 27-percent probability 5 years or more after implantation. For primary prevention, 35 percent of the patients with appropriate ICD interventions had undergone implantation for only a single risk factor; likelihood of appropriate discharge was similar in patients with 1, 2, or 3 or more risk markers.
The results of this international, multicenter study show the effectiveness and reliability of the ICD in prevention of sudden cardiac death in high-risk patients with HCM, the authors write. An important proportion of these device interventions occurred in patients who had undergone prophylactic ICD implantation for a single risk factor. Therefore, a single marker of high-risk status may justify consideration for a primary prevention defibrillator in selected patients with HCM.
In an accompanying editorial, Rick A. Nishimura, MD, and Steve R. Ommen, MD, of the Mayo Clinic College of Medicine, Rochester, Minnesota, comment on the findings of the study by Maron and colleagues.
Patients who have experienced cardiac arrest or documented sustained ventricular tachycardia definitely should be considered for implantation of an ICD. Patients with 2 or more risk factors likely present a high enough risk to warrant implantation of an ICD. However, the decision to implant an ICD in any patient, especially one with a single risk factor, must include a thorough and earnest discussion of the accuracy of the current risk assessment tools, the risks and benefits of ICD therapy, and the individual patient's viewpoints on procedures, devices, and death. Such an approach will allow the patient-physician team to arrive at an individualized decision regarding ICD implantation.
Source: JAMA. 2007;298(4):405-412, 452-454.

Abbott Enrolls First Patient in Clinical Trial Designed to Study Drug-Eluting Stent Treatment in Women
XIENCE V SPIRIT WOMEN Trial Designed to Evaluate the Xience V Everolimus Eluting Coronary Stent System in the Treatment of Women with Cardiovascular Disease
Abbott announced that the first patient was enrolled in its XIENCE V SPIRIT WOMEN clinical trial, a clinical trial designed to study the safety and effectiveness of drug-eluting stent (DES) treatment in women. Liliana Grinfeld, MD, of the Hospital Italiano in Buenos Aires, Argentina, performed the first procedure.
The goal of the XIENCE V SPIRIT WOMEN trial is to increase understanding of how heart disease affects women and to assess the performance of the Xience V everolimus eluting coronary stent system in women with previously untreated coronary artery lesions from Europe, Asia-Pacific, Canada and Latin America. The trial will focus on specific aspects of women's health in relation to coronary artery disease such as general awareness about the disease, symptoms at time of presentation, referral patterns, and hormonal menopausal status.
Dr. Grinfeld noted, The Xience V stent performed well, and as with all patients enrolled in the XIENCE V SPIRIT WOMEN trial, the patient will be followed out to 5 years."
Each year, more women than men die of cardiovascular disease (CVD), and yet women receive only 33 percent of angioplasties, stents and bypass surgeries; 28 percent of implantable defibrillators; and 36 percent of open-heart surgeries.1
"With more women dying of cardiovascular disease than men, it is tragic that women comprise only 25 percent of participants in all heart-related research studies," said Marie-Claude Morice, MD, Institute Jacques Cartier, Massy, France, and principal investigator for XIENCE V SPIRIT WOMEN.
Women with CVD may be under-treated because disease diagnosis is more challenging in women than in men. Women typically exhibit different symptoms than men, and their symptoms often are more gradual and subtle. For example, rather than the more commonly recognized symptoms such as the sudden violent chest pain, or uncomfortable pressure or fullness that are predominant in men, women may experience other warning signs such as shortness of breath, dizziness, nausea, indigestion, vomiting, unexplained fatigue, and back, shoulder blade or jaw pain.2 XIENCE V SPIRIT WOMEN will yield specific data on how the disease presents in women.
XIENCE V SPIRIT WOMEN will include approximately 2,000 women from about 100 sites throughout Europe, Asia-Pacific, Canada and Latin America. The trial will evaluate patient and disease characteristics specific to women such as menopausal status and hormonal profiles, as well as treatment outcomes including death, heart attack, target vessel revascularization (TVR) and potential risk of stent thrombosis.
XIENCE V SPIRIT WOMEN represents the sixth study in the SPIRIT Clinical Trial Program, and will increase the number of patients being studied in the SPIRIT family of trials to approximately 10,000. The six studies evaluating Xience V for the treatment of coronary artery disease are:
SPIRIT FIRST, a randomized trial comparing the Xience V with the Multi-Link Vision metallic stent system.
SPIRIT II, a randomized clinical trial evaluating Xience V versus Taxus in Europe and Asia Pacific.
SPIRIT III, a large-scale randomized pivotal clinical trial comparing Xience V to Taxus in the United States and Japan.
SPIRIT IV, a randomized trial currently enrolling patients and will evaluate the safety and efficacy of Xience V for the treatment of coronary artery disease in a more complex patient population in the United States.
SPIRIT V, an international clinical trial currently enrolling patients that will provide additional data on clinical experience with Xience V at 100 clinical sites throughout Europe, Asia Pacific, Canada and Latin America.
XIENCE V SPIRIT WOMEN will evaluate the characteristics of women undergoing stent implantation as well as the performance of Xience V in those patients in Europe, Asia-Pacific, Canada and Latin America.

Xience V was launched in Europe and Asia Pacific in 2006. Xience V is currently an investigational device in the United States and Japan. Abbott completed its Premarket Approval (PMA) submission of the Xience V system to the United States Food and Drug Administration (FDA) in June 2007.
The Xience V system utilizes everolimus, which has been shown to reduce tissue proliferation in coronary vessels following stent implantation, and the Multi-Link Vision Coronary Stent System.
Xience V is designed, studied and manufactured by Abbott Vascular. Abbott supplies a private-labeled version of Xience V to Boston Scientific, called the Promus, as part of a distribution agreement established between the two companies last year.

References
1. National Center on Health Statistics; National Heart, Lung and Blood Institute; and American Heart Association's 2002 Heart and Stroke Statistical Update.
2. World Heart Federation

Boston Scientific Announces First Human Use of Taxus® Petal Bifurcation Stent
Boston Scientific Corporation announced the successful implantation of its Taxus® Petal Bifurcation Paclitaxel-Eluting Stent System (Taxus Petal Stent) in a patient in New Zealand, marking the beginning of the TAXUS PETAL I First Human Use (FHU) Trial. The trial is designed to evaluate the safety of a dedicated bifurcation paclitaxel-eluting stent platform for the treatment of coronary artery disease. The procedure was performed by John Ormiston, MD, at Auckland City Hospital in Auckland, New Zealand.
A significant percentage of coronary artery disease as much as 30 percent occurs at a bifurcation. The Taxus Petal Stent is designed specifically to treat both the main branch and the side branch of a bifurcation.
The Taxus Petal Stent consists of a traditional drug-eluting stent with a side structure (the Petal Strut) in the middle of the stent that opens into the side branch. The Taxus Petal is designed to provide access, coverage and support to the critical areas of the bifurcation and uses a proprietary platinum chromium alloy. Platinum chromium is designed to offer an improvement over stainless steel and cobalt chromium, enabling thinner struts, increased flexibility and improved radiopacity. The Taxus Petal Stent is coated with a combination of paclitaxel and a Translute polymer.
Dr. Ormiston is the principal investigator for the TAXUS Petal I FHU Trial. The TAXUS PETAL I FHU clinical trial is a non-randomized study with an initial assessment of acute performance and safety (death, myocardial infarction, target vessel revascularization) at 30 days and six months, as well as continued annual follow-up for five years. TAXUS PETAL I FHU will enroll a total of 45 patients in New Zealand, France and Germany. Upon successful completion of this study, Boston Scientific intends to begin a pivotal trial to gain U.S. and international approval for the commercialization of the Taxus Petal Stent.
The TAXUS Petal Stent is under development and not available for sale.
Toshiba Partners with CVCTA Education to Offer New PV-CTA Training Course
Toshiba America Medical Systems, Inc. has partnered with CVCTA Education to provide a Peripheral Vascular CTA (PV-CTA) training course. This course will be the first of its kind to exceed current ACCF/AHA Level 2 requirements in the ACCF/AHA Clinical Competence Statement on Cardiac Imaging with Computed Tomography and Magnetic Resonance.
The PV-CTA training course will be offered at CVCTA Training Centers in San Francisco, New York and Houston, several times per month, with the first course starting in September. The course will use a blend of online learning and in-person training on Toshiba's Aquilion CT scanners. Students will complete six hours of online didactics covering a review of anatomy and function, as well as findings and reporting. Also, in one day of hands-on workstation training, the students will be mentored on more than 25 cases of varying pathology. Students also will work on more than 75 cases via CVCTA's proprietary MedMind CTA training software.
Created by Dr. Peter Fail from the Cardiovascular Institute of the South and Dr. Tony DeFrance from CVCTA, the PV-CTA course will provide students with more than 100 mentored cases with a wide variety of pathology, therefore exceeding the anticipated Level 2 requirements set by the ACCF and AHA. In total, the student will receive 40 hours of CME credit.
Additional information on the Toshiba's PV-CTA course offered at CVCTA can be found at www.medical.toshiba.com or www.cvcta.com.

U.S.News Ranks Cleveland Clinic Heart Center No. 1
For the thirteenth consecutive year, Cleveland Clinic's cardiac care has been ranked No. 1 in the U.S., according to the 2007 U.S. News & World Report America's Best Hospitals survey.
The survey recognized Cleveland Clinic as one of the nation's best hospitals overall, ranking the Clinic as No. 4 in the country. The Clinic ranked in all 16 specialties surveyed by the magazine. Twelve of its specialties were listed among the Top 10 in the United States. All the Clinic's specialties placed in the nation's top 20.
At Cleveland Clinic, delivering high-quality, patient-centered healthcare is at the heart of everything we do, said Delos M. Toby Cosgrove, MD, President and CEO of Cleveland Clinic. I commend our physicians, nurses and all employees for their tireless dedication and efforts in putting patients first and providing them with high-quality, compassionate healthcare. The U.S. News survey data provides a useful benchmark as we continue to provide world-class medical care.
The complete 2007 national rankings for Cleveland Clinic are: heart and heart surgery 1; digestive disorders, 2; urology, 2; orthopedics, 4; rheumatology, 4; kidney disease 5; respiratory disorders, 5; neurology and neurosurgery, 6; endocrinology, 6; gynecology, 7; ear, nose and throat, 9; geriatrics, 9; ophthalmology, 12; cancer, 17; psychiatry, 19; and rehabilitation, 20.
According to U.S. News & World Report, of 5,462 hospitals evaluated by the magazine, 173 scored high enough in measures of quality, including mortality and patient volume, to be ranked in at least one specialty this year.
RTI International, Research Triangle Park, N.C., compiled all hospital data and developed the 2007 rankings on behalf of U.S. News & World Report. In 12 of the 16 specialties ranked, hard data largely determine a hospital's position. In the other four, (ophthalmology, psychiatry, rehabilitation and rheumatology) the rankings are based on each program's reputation among specialist physicians.

Vascular Solutions Launches Gopher Support Catheter
Vascular Solutions, Inc. recently launched the Gopher Support Catheter, a support catheter with a twist for treating coronary and peripheral stenoses.
Designed for use when treating coronary and peripheral stenoses over an existing inplace 0.014 guidewire, the Gopher Support Catheter combines a highly torqueable nitinol laser-cut backbone with a 3F threaded distal tip, resulting in a catheter that can pull itself across a stenosis when rotated by the operator in a clockwise direction. The Gopher Support Catheter also features a fully sealed polymer-jacket shaft to allow contrast and medication delivery, guidewire support and exchange. The Gopher Support Catheter is currently available in the United States and will also be available in Europe.