Datascope Launches ProLumen Thrombectomy Devices for Dialysis Access Market

Datascope Corp. announced the company’s entry into the dialysis access market in the U.S. with the launch of the ProLumen™ thrombectomy device. The company will launch the ProLumen device at the Society of Interventional Radiologists (SIR) meeting in Phoenix, on Friday, March 26, 2004.

An estimated 290,000 people in the U.S. require dialysis access, with this number increasing at a rate of 6% annually. For over 100,000 of these people, dialysis access is obtained through implanted synthetic grafts, which typically require thrombectomy more than once per year. ProLumen is designed to quickly and effectively clear clotted grafts.

Migraine Sufferers Have More Genes that Produce Platelets

People who suffer from migraine headaches appear to express more genes that produce platelets, researchers report. This finding could lead to “future identification of migraine sub-types that would be able to be identified by a blood test,” Dr. Andrew D. Hershey said. “This may evolve into individualized treatment based on the gene expression.”

Hershey, at Children’s Hospital Medical Center in Cincinnati, and his colleagues note in the medical journal Headache that migraine has a strong genetic component.

To see if genetic profiling might shed more light on the matter, the researchers examined blood cell samples from 22 patients with migraine and a comparison group of 56 controls.

A group of platelet genes was upregulated in the migraine group, and different expression patterns were seen in people who had occasional migraine and those with chronic migraine. Compared with controls, 40 genes were upregulated in migraine and 353 were upregulated in chronic migraine. The platelet gene finding, say the researchers, indicates that occasional and chronic migraine has similar but overlapping causes.

“The biggest implication of the study," added Hershey, “is a new way to uncover the underlying (cause) of this poly-genetic disorder.”

With Diabetes, Women Do Worse After Stenting

When people with type 1 or type 2 diabetes</a> undergo coronary artery stenting, women are more at risk for major adverse events than men, physicians report. In particular, restenosis is more likely to occur among women.

Consequently, diabetic women may benefit even more than diabetic men from coronary bypass surgery, as well as from anti-platelet drugs or drug-eluting stents to prevent restenosis, Dr. Gjin Ndrepepa and colleagues suggest.

Ndrepepa’s group, at Technischen Universitat Munich, followed 4460 patients who underwent coronary artery stenting for angina between 1995 and 2000. The group included 658 men and 312 women who had diabetes.

Six months after the stent procedure, women with diabetes were 50 percent more likely to see their arteries re-clog than nondiabetic women, but this was not the case for diabetic and nondiabetic men, the team reports.

The cumulative rate of death, heart attack, and need for another procedure after one year was also 50 percent higher in women with diabetes than those without. For men, the increased risk with diabetes was only 7 percent.

Diabetes seems to accentuate menopause-related vascular alterations, Ndrepepa’s team proposes, and this may heighten a woman's propensity to form blood clots.

From: American Journal of Medicine, Dec 1, 2004.

Medicare Approves Expanded Payment for Guidant Stent

Medicare said it would pay for more patients to get a less-invasive stent treatment to prevent stroke, a decision that will benefit device maker Guidant Corp.

The U.S. Centers for Medicare and Medicaid Services said it would approve paying for stents in patients who are at risk for an alternative but riskier surgery. Previously Medicare only paid for their use in clinical trials and marketing safety studies.

Regulators included a caveat to the decision in that it would require the procedure be performed only at facilities who demonstrate expertise in stenting.

Aspirin Underused by People with Diabetes

While the proportion of diabetic patients who take aspirin has increased in recent years in the US, new research indicates that some are still not doing so.

Women and adults younger than 50 years of age with diabetes are underusing this effective and inexpensive strategy to ward of a heart attack, according to a new report.

The findings are based on telephone surveys conducted in several states between 1997 and 2001. Data from more than 8000 people with diabetes were included in the analysis. Aspirin use rose from 37.5 percent in 1997 to 48.7 percent in 2001, Dr. Stephen D. Persell and Dr. David W. Baker, from Northwestern University in Chicago, report.

In 2001, the use of aspirin among diabetics was high when they had actual cardiovascular disease, but low when they were still free of heart problems. Moreover, less than 40 percent of diabetics who were smokers or had high blood pressure or high cholesterol used aspirin.

Compared with men 65 years or older, women 35 to 49 years were much less likely to take aspirin. Women 50 to 64 years old and men 35 to 49 also tended to make less use of aspirin.
The team believes that doctors may play a key role in making people with diabetes aware of the importance of taking aspirin. They add that “interventions that aim to increase professional counseling about aspirin for women, as well as young and middle-aged adults, may be especially helpful.”

From: Archives of Internal Medicine, December 13/27, 2004.

Clinical Study Shows Closure Procedure Offers Patient Benefits
VNUS Medical Technologies, Inc. announced the publication of new results from a randomized, international multi-center trial with two-year follow-up of the Closure® procedure versus traditional vein stripping. The Closure procedure is the leading minimally-invasive treatment for superficial venous reflux disease.

In addition to demonstrating a high level of efficacy in a randomized trial, the new study is significant because the short-term benefits for patients treated with Closure over vein stripping were shown to be durable longer-term.

The EVOLVeS trial was conducted at five centers in a prospective, randomized trial. In particular, the new results show that patients enjoy significantly better quality of life and experience less pain even at one and two years as compared to vein stripping.

Dr. Fedor Lurie, MD, PhD, of the Straub Clinic and Hospital, the lead author of the EVOLVeS trial paper, stated, “At two years, ultrasound follow-up demonstrated that in the vast majority of Closure patients the great saphenous vein remained permanently closed, and underwent progressive shrinkage to eventual sonographic disappearance. Superior quality of life was demonstrated to be an early advantage of Closure, and this has persisted throughout the two-year study period.”

IMI Expands Skin Sterol Research
Predictive medicine company IMI International Medical Innovations Inc. will initiate a new clinical trial to evaluate the relationship between skin sterol values and a variety of new and established coronary artery disease (CAD) markers, including ankle/brachial blood pressure index (ABI) and vascular compliance, in high-risk patients.

Dr. Brent Norton, President and CEO of IMI, said “We already know skin sterol correlates with the presence and extent of coronary artery disease. This study could expand the scientific foundation of our skin sterol technology, and show how it and other markers change in response to various therapies.”

The study will be performed at Providence Hospital, in Vancouver, British Columbia, which is affiliated with the University of British Columbia (UBC). The trial will be conducted in collaboration with AtCor Medical Pty. Ltd, an Australia-based company specializing in cardiovascular diagnostic products, and the university.

One hundred patients at high risk for cardiovascular disease not currently taking cholesterol-lowering medication will be examined using Prevu(x) Point of Care Skin Sterol Test, a non-invasive cardiovascular disease risk assessment test, as well as the lab-processed format of the technology, Prevu(x) Skin Sterol Test (LT). Another marker included in the trial is AtCor’s SphygmoCor Px Aortic BP Profile System, a tool that derives the calibrated blood pressure waveform from radial artery blood pressure, which is also measured non-invasively. Markers of inflammation, markers produced by fat cells, and specialized lipid tests, among others, will also be included in the study. Patients who have received various therapies after baseline testing will be examined again in six months.

Prevu(x) Point of Care Skin Sterol Test does not require fasting or the drawing of blood. It tests the amount of sterol in the skin tissue. Clinical studies have shown that as cholesterol accumulates on artery walls it also accumulates in other tissues, including the skin. High levels of skin sterol are correlated with higher incidence of CAD. Prevu(x) POC has been approved for sale in Canada, the U.S. and Europe (as Cholesterol 1,2,3™).

Heavy Drinking Linked to Higher Stroke Risks
A new study led by researchers at Beth Israel Deaconess Medical Center (BIDMC) and the Harvard School of Public Health (HSPH) has found that heavy drinkers — men who consume an average of three or more alcoholic beverages per day — are nearly 45 percent more likely to suffer an ischemic stroke compared with nondrinkers. The study also found that while light and moderate drinkers appear to be at neither greater risk nor greater advantage than abstainers when it comes to ischemic stroke, the frequency with which they consume alcohol may modestly influence their risk.

During the course of the 14-year study the authors followed 38,156 participants who are part of the HSPH-based Health Professionals Follow-up Study. Beginning in 1986 and continuing every four years thereafter until 2000, the male participants, who ranged in age from 40 to 75, responded to a detailed questionnaire regarding diet and medical history, including alcohol consumption.
Researchers examined the following factors to gauge the influence of alcohol consumption on the risk for ischemic stroke: average amount of alcohol consumed; drinking patterns; and type of beverage consumed. They also looked at the incidence of both subtypes of ischemic stroke — thrombotic and embolic. During the course of the study, they confirmed 412 cases of ischemic stroke among the study participants.

Their findings showed that men whose average alcohol intake was three or more drinks per day had a 42 percent higher risk of ischemic stroke (particularly embolic stroke) than did abstainers.

Although the findings also found that average intake of lower amounts of alcohol was associated with neither a significantly higher nor lower risk of stroke, when drinking frequency was taken into account, the light and moderate drinkers who consumed alcohol three to four days per week had a modest 32 percent lower stroke risk than did nondrinkers.