Conor Medsystems Completes Clinical Trial for Optimization of Paclitaxel Drug Delivery Stent
Conor Medsystems, Inc., a vascular drug delivery company developing stents for controlled delivery of therapeutic agents, has completed enrollment for a clinical trial evaluating Medstent, the company™s paclitaxel drug delivery coronary stent.

The clinical trial, known as PISCES (Paclitaxel In-Stent Controlled Elution Study), is a multi-center, comprehensive dose optimization study involving 190 patients in 9 sites across 7 countries. The PISCES trial compares the safety and performance of six different formulations of paclitaxel for reducing restenosis in the treatment of native coronary artery lesions. The goal of this study is to determine the optimal release characteristics for paclitaxel in order to minimize angiographic late loss without exhibiting long-term persistence or toxicity of the drug and polymer. Within the 6 different groups, variables include drug release rate, dose, and directionality.

The Conor stent is a non-surface-coated stent with drug delivery capabilities. With the patented Conor stent, the proprietary bio-erodable polymer drug and formulations are loaded into hundreds of non-deforming holes within the stent struts, allowing the release profile to be tailored to the requirements of the drug.

Results from the PISCES clinical trial will be announced in May at the EuroPCR meeting in Paris. John F. Shanley, Chief Technology Officer at Conor, notes, The PISCES trial will demonstrate for the first time in human stent trials whether kinetic release patterns are important factors in safety and efficacy.

Conor's proprietary technologies allow release profiles to be tailored to the requirements of a drug and enable the delivery of multiple compounds to various sites in the body.

New Study Shows Composition of Walnuts Improves Endothelial Function
A new clinical study shows that substituting walnuts for monounsaturated fat in a Mediterranean diet improves, and even restores, endothelial function. Walnuts also reduce harmful cell adhesion molecules which are associated with atherosclerosis. These dual effects enhance the circulatory system, therefore aiding in the prevention of heart disease.

The study concludes that the results provide further support for the inclusion of walnuts in healthy diets. This is the first time a whole food diet, not its isolated components, has shown this beneficial effect on vascular health, according to Emilio Ros, MD, the Hospital Clinic of Barcelona, researcher who directed the study at the setting of the Institute of Biomedical Research August Pi i Sunyer (IDIBAPS). Dr. Ros notes, Compared with the Mediterranean diet, the walnut diet increased endothelium-dependent vasodilation by 64 percent and reduced levels of vascular cell adhesion molecule-1 by 20 percent. In addition, as in previous studies, the walnut diet decreased total cholesterol and LDL cholesterol.

Dr. Ros cites the powerful nutrient profile of walnuts as providing this capacity to improve vascular elasticity. Specifically, he notes that, Walnuts differ from all other nuts because of their high content of alpha-linolenic acid (ALA), a plant-based omega-3 fatty acid, which may provide additional anti-atherogenic properties.

He also references the amino acid L-arginine, and the gamma-tocopherol form of vitamin-E, both of which walnuts are rich in, as effective in preventing harmful vascular blockage.

The patients in our study had high blood cholesterol and this abnormality was corrected by the walnut diet. The encouraging results of this study provide physicians and patients with a powerful, yet simple, nutritional tool in their fight against heart disease, he says.

Conducted by the Lipid Clinic at the Hospital Clinic of Barcelona, 21 men and women (ages 25“75) with high cholesterol followed a cholesterol-lowering Mediterranean diet, and a diet of similar energy and fat content in which approximately 1.4“2.3 ounces of walnuts daily (equivalent to 40-65 grams or 8“13 walnuts), based on subjects™ total caloric intake, replaced roughly 32% of the energy from monounsaturated fat. Participants followed each diet for 4 weeks.

GMP Companies Announces Availability of Lifesync® Wireless ECG System
GMP Companies, Inc. announced today the availability of the LifeSync® Wireless ECG System, following successful clinical trials at three U.S. hospitals. Cleared by the U.S. Food and Drug Administration (FDA), the LifeSync System is the first ECG (electrocardiogram) system enabled by Bluetooth® Wireless Technology.

Mercy Hospital in Miami, Fla., Piedmont Hospital in Atlanta, Ga. and George Washington University Hospital in Washington D.C., were the first hospitals in the nation to evaluate the wireless ECG system. The LifeSync System was evaluated on approximately 400 patients in different departments at the three hospitals, including the cardiac care unit (CCU), intensive care unit (ICU), cardiac stress and cardiac catheterization labs, and the admission and recovery units for pre and post cardiac catheterization procedures. ECG monitoring using the LifeSync System compared favorably with traditional wired ECG monitoring. Other departments that may benefit from the LifeSync System include the emergency department, operating rooms, gastrointestinal units and bronchoscopy and endoscopy suites. 

The LifeSync System eliminates lead wires and trunk cables between patients and bedside, 12-lead or transport ECG monitors. The system employs two-way radios that transmit and receive patient ECG and respiration data to existing ECG monitors, and replaces lead wires with a disposable LeadWear System. The LifeSync System can be implemented without costly changes to a hospital™s infrastructure. The system is designed to save critical nurse time by eliminating the need to detach and reattach lead wires when transporting patients, and also facilitates patient mobility and ambulation. The LifeSync System provides the opportunity for enhanced patient comfort and may reduce the risk of cross contamination from reuse of lead wires. 

The patented LifeSync System, developed by GMP Wireless Medicine, Inc., uses standard ECG electrodes which are attached to the disposable LeadWear System worn by the patient. Two electronic components, the Patient Transceiver and the Monitor Transceiver, function as two-way radios that collect and transmit ECG and respiration data to existing bedside or transport ECG monitors. The Patient Transceiver, worn on the patient, communicates with the Monitor Transceiver, placed on or near the ECG monitor. The transceivers are synchronized with a pairing token to establish a secure and robust radio link between the Patient Transceiver and the ECG monitor. The LifeSync System has also received approval from the FCC to operate using public radio frequencies required for signal transmission. The LifeSync System is now available within the U.S. For more information, visit www.wirelessecg.com

Alcohol Use May Help After Stenting
Moderate alcohol use may benefit patients who have undergone coronary stenting by inhibiting inflammation. Investigators note that several studies have shown that moderate alcohol intake (up to 2 drinks per day) reduces the risk of death due to heart disease. But data on alcohol™s effect on long-term prognosis after successful coronary stenting are lacking.

To investigate, Dr. Michael N. Zairis from Tzanio Hospital in Piraeus, Greece and colleagues analyzed data on alcohol intake, CRP, and mortality in 483 subjects who underwent coronary stenting.

By the end of the 4-year study, 23 percent of subjects were readmitted for chest pain, had a heart attack, or died from heart-related causes. Moderate alcohol use decreased the risk of all these outcomes provided that the patient™s CRP level was above a certain level. Although the heart benefits of alcohol have been largely attributed to its effects on blood fats and platelets, the current results suggest the benefits may be mediated, at least in part, through an anti-inflammatory mechanism.

Two researchers from France recap published studies both for and against the intriguing and appealing theory that moderate alcohol intake protects the heart through anti-CRP effects. Dr. Michel de Lorgeril and Dr. P. Salen from UniversitÈ Joseph Fouriar in Grenoble, France, note that at present, there is no evidence that CRP is a causal (or even a major) factor in the blood vessel inflammation that leads to coronary plaques. Further studies are obviously required, they say.

St. Luke's Medical Center in Wisconsin Offers 24-Hour On-Site Catheterization
St. Luke™s Medical Center in Milwaukee, Wisconsin recently became the only hospital in the country to offer patients catheterization by an on-site interventional cardiologist and staff 24-hours a day, 7-days a week.

The American College of Cardiology and the American Heart Association both support a guideline for angioplasties to be performed within 90 minutes of hospital arrival. By having a cardiologist and staff on-site 24-hours a day, St. Luke's will be able to perform angioplasties much quicker than even the 90-minute guideline.

We know that, up to a point, the faster you open an artery, the more likely you are to minimize the permanent damage to the heart muscle, says Matthew Mick, MD, an interventional cardiologist at St. Luke™s.

Between July 2002 and June 2003, St. Luke™s performed more than 3300 angioplasties. The next closest Wisconsin hospital performed 846 of the same procedures. In addition, the catheterization labs at St. Luke's are some of the busiest in the state, with more than 13,000 procedures (angioplasties, diagnostic catheterizations, stent cases) performed there last year.

Enrollment Underway in First Drug-eluting Coronary Stent Registry Assessing Impact of Stent-Deployment Technique on Patient Outcomes
eCYPHERSM S.T.L.L.R. Registry to Include 1,500 patients at 50 U.S. Treatment Centers
Patient enrollment is underway in the eCYPHERSM S.T.L.L.R.* Registry, the first study specifically designed to evaluate the impact of stent-deployment technique on patient outcomes achieved with the Cypher® Sirolimus-eluting Coronary Stent. Sponsored by Cordis Corporation, a Johnson & Johnson company, the prospective, nonrandomized study will include approximately 1,500 patients at 50 U.S. treatment centers.

Findings from earlier Cypher stent trials strongly suggest that refinements in stent-deployment technique can further enhance the positive long-term outcomes recorded to date in patients who receive a Cypher stent, explained Dennis Donohoe, MD, Cordis™ vice president of Regulatory and Clinical Affairs. We believe the lower binary restenosis rate documented in the NEW SIRIUS study versus that observed in the original U.S. SIRIUS trial (5.1% vs. 8.9%) was strengthened by improvements in stent-deployment technique by physicians. Our goal with the eCYPHERSM S.T.L.L.R. Registry is to focus on technique and better define procedures that help to ensure the best possible results for patients.

The primary study endpoint for the registry will be target lesion revascularization. The registry will also be looking at a variety of secondary endpoints, one of the more important being geographical miss.

The eCYPHERSM S.T.L.L.R. Registry will also use software enabling registry sites to share angiographic images and other patient data via the Internet. Patient data will be electronically captured and shared with The University of Florida Cardiovascular Imaging Core Laboratories through study-sharing software.

Investigators will transmit angiograms and other critical information to a central database, accessed by all sites in the registry, said Principal Investigator Marco Costa, MD, PhD, director of research, The Cardiovascular Center, University of Florida, Jacksonville, FL. Dr. Costa said the service will significantly increase the speed of tracking and analyzing registry findings.

To qualify for enrollment in the registry, patients must have a de novo native coronary artery lesion of < 30 mm in length.

(*S.T.L.L.R.: Study to evaluate DES Deployment Technique on CLinicaL Results)

Thin Bones Predict Heart Disease in Women
Thin bones, as determined by X-rays of the hand, predict heart disease in women, according to a new report. This raises the possibility that treatments to prevent osteoporosis may also reduce the risk of heart disease.

Although thin bones have been linked to stroke in women, no studies have looked at the ability of bone thickness to predict heart disease, Dr. Elizabeth J. Samelson, from Harvard Medical School in Boston, and colleagues state.

To investigate, the researchers analyzed data from 1,236 women and 823 men who participated in The Framingham Study. The subjects were free from heart disease at the beginning of the study (1967-1970) when hand X-rays were taken. The participants were followed through the end of 1997 to assess the rate of heart disease.

The rate of heart disease ranged from 11.76 to 15.65 cases per 1000 persons per year for groups with the thickest to thinnest bones in the hand, respectively. In contrast, no association between heart disease risk and bone mass was seen in men.

The presence of this relationship in women only may reflect gender differences in how bone is mineralized, how heart disease evolves, or both, the researchers note. The results suggest that boosting bone density may also prevent heart disease, the researchers say. To draw definitive conclusions regarding the implications of these findings on the treatment or prevention of osteoporosis, further studies are needed that use current tests of bone thickness.

Aspirin Treatment Reduces Daily Life Ischemia
A regular-strength aspirin taken every day reduces coronary ischemia experienced by people with cardiovascular disease, a Greek study shows. The researchers found that the benefits of aspirin in reducing ischemia came about through the inhibition of various factors that promote blood-clot formation, including a substance called macrophage colony stimulating factor (MCSF).

These findings are clinically relevant, as daily life ischemia and MCSF plasma concentrations, are both known to predict adverse outcomes in individuals with chronic coronary artery disease (CAD), the investigators note.

Dr. Ignatios Ikonomidis from the University of Athens and colleagues identified 40 people with chronic stable CAD who were seen to have periodic ischemia when they wore a heart monitor for 48 hours. They were then given either 300 milligrams of aspirin or an inactive placebo daily for 3 weeks, after which they were switched to the other treatment.

The total number of ischemic episodes fell from 339 during placebo treatment to 251 during aspirin treatment, and the total duration of these episodes fell from 1765 minutes to 1305 minutes.

Aspirin therapy also significantly reduced concentrations of key blood-clotting and inflammatory markers.

We report for the first time that aspirin treatment at a dose of 300 milligrams reduces daily life ischemia in parallel to reduction of platelet activation, thrombin generation, and inflammation, Ikonomidis said.

Daily life ischemia, in addition to platelet activation, thrombin generation and inflammation, are determinants of prognosis, the researcher said, and thus their reduction by 300 milligrams of aspirin may prevent transient coronary flow reductions and improve long term prognosis in this group of patients.

FUTURE III Clinical Trial in Europe; Everolimus Eluting Stent Trial Will Provide Additional Safety and Performance Data
The first patient has been enrolled in FUTURE III, an 800-patient clinical trial that will provide additional safety and performance data to support market launch of Guidant Corporation™s investigational Champion Everolimus Eluting Coronary Stent System outside the U.S.
FUTURE III is a randomized clinical trial comparing the Champion Everolimus Eluting Coronary Stent System to Guidant™s Multi-Link Zeta® Coronary Stent System at approximately 90 sites in Europe, the Middle East, Asia, Australia, Canada and New Zealand. The primary endpoint of the trial is in-segment late loss at 4, 6 and 12 months following stent implantation.

The trial is designed to show superiority of the Champion Everolimus Eluting Coronary Stent System, which approximately 600 patients will receive, over the Multi-Link Zeta Coronary Stent System,which approximately 200 patients will receive. The company expects to present 30-day MACE (major adverse cardiac event) data from the first 120 patients enrolled in FUTURE III before the end of 2004.

Dr. Ulrich Gerckens performed the first implant at the Herzzentrum Siegburg in Germany. Prof. Eberhard Grube, also of the Herzzentrum Siegburg, is the principal investigator of FUTURE III.
The company expects to launch the Champion Everolimus Eluting Coronary Stent System in Europe in the first quarter of 2005, pending regulatory approvals.

Guidant™s first everolimus eluting stent, the Champion Everolimus Eluting Coronary Stent System, utilizes a bioabsorbable polymer on a stainless steel stent platform with Guidant™s Multi-Link Vision® Delivery System. Guidant™s second everolimus eluting stent, the cobalt chromium Multi-Link Vision-based stent system currently being evaluated in the SPIRIT FIRST trial, utilizes a durable polymer.

Guidant™s clinical trials employing bioabsorbable polymer technology utilize the FUTURE designation in the study name. The company's clinical trials utilizing durable polymer technology are identified by the SPIRIT designation in the study name.

FUTURE I and FUTURE II evaluated safety and performance of an everolimus eluting stent with a bioabsorbable polymer drug carrier and stainless steel stent platform. Results from the FUTURE I and II clinical trials demonstrated safety and efficacy. There was a profound effect in preventing in-stent restenosis (binary angiographic restenosis), with no restenosis at six-month follow-up among patients receiving an everolimus eluting stent (0/46) and an 87 percent reduction of in-stent late loss compared to a metallic stent control.

FUTURE III is an 800-patient clinical trial currently enrolling patients that will provide additional safety and performance data to support market launch of the Champion Everolimus Eluting Stent System outside the United States. Another planned trial, FUTURE IV, is a 975-patient U.S. pivotal trial for the Champion Everolimus Eluting Stent System.

The initial trial in the SPIRIT series, SPIRIT FIRST, enrolled a total of 60 patients at multiple sites in The Netherlands, Denmark and Germany. The primary endpoint of the study is in-stent late loss at 6 months.
 
Some Doctors Choosing Cash Over Insurance
When Chuck O™Brien visits his doctor, they talk about his aches and pains, his heart problems and his diet, but never about his health insurance. That™s because Dr. Vern Cherewatenko is one of a small but growing number of physicians across the country who are dumping complicated insurance contracts in favor of cash.

Is this the health care wave of the future? Probably not, experts say. Most people are content with monthly premiums and $10 copays; nine out of 10 doctors contract with managed-care companies. But cash-only medicine is becoming an increasingly attractive option for doctors frustrated by red tape and for the 43 million Americans who lack health insurance.

It™s a terrible indictment of the collapsing health care system, said Arthur Caplan, chairman of the medical ethics department at the University of Pennsylvania Medical School. Insurance and managed care were supposed to streamline instead what they've done is add so much paperwork and bureaucracy they're driving some doctors out.

When O™Brien leaves the exam room, he writes a check for $50 and he™s done no forms, no ID numbers, no copayments.

This is traditional medicine. This is what America was like 30 years ago, said O™Brien, 55 and self-employed, who believes he has saved thousands of dollars by dropping his expensive insurance policy and paying cash. It™s a whole world of difference.

Health insurers downplay the trend, while emphasizing recent efforts to mend tattered relationships between doctors and managed care companies.

I don™t look at it as a threat, said Mohit Ghose, spokesman for the industry group America™s Health Insurance Plans. It™s just a different way of practicing.

Medical establishment leaders don™t object to doctors working for simple cash.

This is America. One size does not fit all, said Dr. John C. Nelson, president-elect of the American Medical Association. We certainly support the physicians™ right to do that.

An obstetrician-gynecologist in Salt Lake City, Nelson easily recalled times when he believed managed care rules prevented his patients from getting the best treatment. He said cash-only doctors are driven by the desire to practice medicine without interference.

There is a great intrusion by third parties into the patient-physician relationship, Nelson said. We can understand their frustration.

Cherewatenko, a broad-shouldered 45-year-old who wears black jackets and red stethoscopes at work, switched to cash out of desperation six years ago. His suburban Seattle practice was hemorrhaging money, and he and his partners realized they were spending hundreds of thousands of dollars just to process insurance paperwork.

We said, ˜Let™s cut out this administrative waste,™ Cherewatenko said. Before, he charged $79 for an office visit and got $43 from an insurance company months later, minus the $20 in staff time it took to collect the payment. Now he charges $50 and he never worries about collection costs, because patients pay in full after every visit.

Cherewatenko sees fewer patients now. His whole office would probably fit inside his old waiting room. But he says the freedom is worth it.

Accounts receivable is zero. It™s a great feeling, Cherewatenko said. I feel like I'm a real doctor again.

He started a group called SimpleCare to spread the gospel of cash-only medicine. The organization steers patients to doctors who offer cash discounts, and gives technical and moral support to doctors who want to start cutting their ties to insurance. Membership has grown to 22,000 patient members and 1,500 doctors. Some reject all insurance and take only cash, while others continue to accept insurance while offering discounts of 15 percent to 50 percent for cash-paying patients.

Independent of SimpleCare, doctors in California, Colorado, Minnesota, Texas, Mississippi and other states have also quit the insurance game. Some tired of the paperwork and administrative expenses. Some wanted to spend more time with patients without managed care bean-counters peering over their shoulders. The patients who pay cash range from poor to wealthy, with most in the blue-collar middle.

When I first started, I thought it would be the elite. That's not the case, said Dr. Shelley Giebel, an obstetrician-gynecologist in Temple, Texas, who washed her hands of insurance eight years ago.

Her standard, hour-long annual checkup costs $140. Everyone pays cash.
If a patient needs extra tests or treatment, Giebel tells them upfront what it will cost.
If it is an urgent test, we™ll go ahead and do it. We're not going to delay medical care because they don™t have the money in hand, she said. Often, patients return later with the money.
It has usually not been a problem that people forgo medical care, she said.

The cash-only movement isn™t just changing the way people pay, it™s changing the way these doctors work. Because of managed care™s low reimbursement rates, doctors on insurance contracts must limit their time with each patient.

Giebel, a typical example, said she would have to double her patient load to make ends meet if she relied on insurance something she can't imagine. How can you possibly talk about prevention of cancer and heart disease when you're seeing patients every 12 minutes? she asked.

They take time here with you, said Jesse Rainwater, a 59-year-old church pastor from Bellevue, Wash., who credits Cherewatenko with teaching him to manage his diabetes. They don™t just bring you in and run you out like a bunch of cattle. You feel like you™re loved.

The cash-only approach evokes Norman Rockwell-tinged visions of country doctors being paid with chickens. The simplicity is tempting, but the truth is many people went without preventive health care in those good old days. A $50 charge can be powerful incentive to delay seeing a doctor until you're in pain which can lead to more expensive health problems later.

Medicine used to be a cash-only business, and there were certainly many people who didn't have the cash, said Caplan, the medical ethicist. Doctors who insist on cash also have an ethical obligation to help people who can't afford the fee, he said even if it means accepting chickens.

Cash crusaders acknowledge the need for some type of insurance. Without it, expensive surgery or hospitalization would force most people into bankruptcy. But they think health insurance should work more like car insurance: you pay for the routine maintenance and little dings yourself, and insurance pays for more expensive repairs.

O'Brien, a freelance marketing specialist, switched from a comprehensive health plan with $300 monthly premiums to a catastrophic plan that costs $75 a month, with a $2,000 deductible. He pays out-of-pocket for routine checkups, and his insurance will kick in if he ever needs expensive care.

The promise of a simple cash payment lured him to Cherewatenko™s office, but the doctor's personal attention keeps him coming back. The $50 exams are just part of the bargain for O'Brien. Cherewatenko recently met him for coffee to talk about improving his diet including an admonition to cut back on caffeine.

How often does your doctor go out and have a cup of coffee with you? O™Brien asked.

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