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Category Archives: Medical School

Atrium Medical Announces Positive Results of INFUSE-AMI Clinical Trial During the American College of Cardiology's …

HUDSON, N.H., March 25, 2012 /PRNewswire/ -- Atrium Medical Corporation, a business unit of MAQUET Cardiovascular, today announced the results of the INFUSE-AMI study (Intracoronary Abciximab Infusion and Aspiration Thrombectomy in Patients Undergoing Percutaneous Coronary Intervention for Anterior ST Segment Elevation Myocardial Infarction (MI)), a multi-center, multi-national clinical trial conducted to determine the optimal treatment strategy for patients with an acute anterior wall myocardial infarction (acute MI or heart attack) with ST segment elevation, commonly referred to as a STEMI. The study findings demonstrated that in patients with large anterior STEMI presenting early after symptom onset and undergoing percutaneous coronary intervention (PCI), intracoronary administration of the platelet inhibitor abciximab delivered directly to the heart attack lesion site via Atrium's ClearWay RX Local Therapeutic Infusion Catheter significantly reduced the size of the MI at 30 days (primary endpoint). The data were presented today in a late-breaking session at the American College of Cardiology's (ACC) 61st Annual Scientific Session in Chicago and published online in the Journal of the American Medical Association (JAMA).

"In patients who have suffered a heart attack, recovery of the heart muscle is often suboptimal despite restoration of blood flow. INFUSE-AMI was uniquely designed to be able to demonstrate whether therapies are able to reduce infarct size in patients with large heart attacks, those with the greatest clinical need," said Dr. Gregg W. Stone, principal investigator of INFUSE-AMI and professor of medicine and director of cardiovascular research and education at New York-Presbyterian Hospital and Columbia University Medical Center. "In these patients, the platelet inhibitor abciximab delivered to the infarct lesion site via the ClearWay RX Infusion Catheter resulted in a significant reduction in infarct size at 30 days. However, manual aspiration of the blood clot did not reduce infarct size."

INFUSE-AMI Study Design and Results

The INFUSE-AMI trial, a prospective, randomized, single-blind trial conducted at 37 clinical sites in the U.S. and five European countries enrolled 452 patients who presented within four hours of a STEMI involving the anterior wall of the heart. Study subjects were randomized to one of four study arms, which assessed four different ways to treat the thrombus (blood clot) causing the patient's heart attack:

The goal of the trial was to help identify which treatment strategy could provide better patient outcomes with the goal of reducing the infarct size (heart muscle damage) during a heart attack and restoring flow in the infarct related artery and microvasculature in the heart muscle without an increase in major and minor bleeding. Study endpoints included impact on infarct size at 30 days as measured by cardiac MRI, ST segment resolution, myocardial perfusion, impact on thrombus burden, and outcomes on bleeding.

Results showed that patients randomized to local therapeutic infusion of intracoronary abciximab with ClearWay RX compared to no abciximab had a significant reduction in 30-day infarct size (15.6 percent relative reduction). Patients randomized to local infusion of intracoronary abciximab also demonstrated a significant reduction in absolute infarct mass (22.1 percent relative reduction). In contrast, manual aspiration thrombectomy did not significantly reduce infarct size. No significant differences in any of the major safety or efficacy endpoints were present between the randomized groups at 30 days. Post hoc analysis revealed median infarct size was lowest in the intracoronary abciximab plus aspiration group compared with the other groups.

The INFUSE-AMI trial was led by the Cardiovascular Research Foundation (CRF) in New York. Dr. Stone was the principal investigator and Dr. C. Michael Gibson, chief of clinical research at Beth Israel Deaconess Medical Center/Harvard Medical School in Boston, served as co-principal investigator. It was sponsored and funded by Atrium Medical Corporation, Medtronic and The Medicines Company.

About the Atrium ClearWay RX Local Therapeutic Infusion Catheter

The ClearWay RX Local Therapeutic Infusion Catheter is an extraordinarily thin, microporous PTFE balloon mounted on a .014" rapid exchange catheter. The ClearWay RX catheter provides super selective, local intracoronary infusion of medication, allowing more medication to act locally at a higher concentration and for a longer period of time to enhance its therapeutic effect on the occluding blood clot and diseased artery. The balloon controllably engages the vessel wall to gently and atraumatically occlude blood flow during infusion thus providing drug concentrations hundreds of times greater at the site of local delivery than traditional systemic drug administration. ClearWay RX maximizes drug availability, concentration, and residence time to greatly enhance the desired therapeutic effect. ClearWay RX is available in 1.0 to 4.0 mm balloon diameters and in balloon lengths ranging from 10 to 50 mm.

About Atrium Medical Corporation

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Harvard Medical School Adviser: Restless leg syndrome

QUESTION: After years of struggling to fall asleep at night, my doctor diagnosed me with restless legs syndrome. What can you tell me about this condition?

ANSWER: Restless legs syndrome (RLS) is a disorder of nerves and muscles that causes an irresistible urge to move the legs. It is often accompanied by an uncomfortable creepy-crawly sensation.

As you've experienced, symptoms of restless legs syndrome typically flare up at night, just as you're settling down in bed. RLS not only causes discomfort and distress, it can wreak havoc on sleep, causing daytime sleepiness and mood changes.

Fortunately, certain lifestyle strategies can help you manage it, and several medications can provide relief for more serious symptoms.

There's a common mistaken belief that RLS refers to the jittery, leg-bouncing movements some people make when they're anxious or overstimulated.

People with RLS describe the discomfort as feelings of prickling, pulling, itching, tugging or stretching that typically occur below the knees and are felt deep within the legs. In severe cases, the arms are affected as well.

Movement provides immediate relief, so people with the condition often fidget, kick or massage their legs, or get up to pace the floor or perform deep knee bends.

Primary RLS, the most common form of the disorder, has no known cause. But more than 40% of people with primary RLS have a family history of the condition. This suggests an underlying genetic component. Researchers found five gene variants that predict a greater likelihood of RLS.

One theory is that primary RLS arises from an imbalance of dopamine, a neurotransmitter with many roles in the body, including the regulation of muscle movement. Some of the medications used to treat RLS work by mimicking the action of dopamine in the brain.

RLS can also develop as a byproduct of other medical problems. One of the chief culprits in this secondary form of the disorder is iron deficiency, which may explain why the condition is more common in women, who are more prone to low iron levels. This is mainly due to blood loss during menstruation. Pregnancy, childbirth and breastfeeding deplete iron stores, too.

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Braun: UMDNJ's debt looms over proposed Rutgers takeover

Gov. Chris Christies determined and sometimes angry push to remake New Jersey higher education has collided with financial realities that include Rutgers Universitys reluctance to take over nearly a half-billion in debt incurred by the states medical school.

Bruce Fehn, Rutgers chief financial officer, said the University of Medicine and Dentistry of New Jersey owes $450 million to bond holders for loans used to build campus facilities. If, as Christie has demanded, Rutgers immediately takes over the medical school and other facilities in Central Jersey, the university could be on the hook for the money.

Worse, the university must deal with conditions, or "covenants," in the loans that could trigger an acceleration repayment clause if UMDNJ loses 15 percent of its assets assets it would lose by transferring them to Rutgers. The long-term loans could become due and payable immediately.

"There has been no analysis of this problem by the state," Fehn said in a meeting of the universitys trustee board on Thursday. Many of the members angrily criticized the Christie plan including one financial expert who compared dealing with the governors office to working with "fourth-graders.

Fehn added that UMDNJs assets were "highly leveraged" so, while it may appear Rutgers was getting more than $400 million in assets, only $50 million was free of debt.

Under the Christie plan, Rutgers would take over UMDNJ facilities in New Brunswick and Piscataway but would lose the Rutgers-Camden campus, with its law and business schools, to Rowan University, a former state teachers college in Glassboro.

Fehn said he was not receiving adequate information from the state to make any judgment about the financial consequences of trying to take over the medical school, especially within the three months demanded by Christie.

The universitys senior vice president for finance and administration also said the university itself doesnt have staff and expertise to make the judgments necessary to assure the trustees they can carry out their "fiduciary" responsibilities. It hired Cain Brothers, an investment firm, to assist the university.

Michael Drewniak, Christies spokesman, issued this statement:

"Rutgers and UMDNJ have both hired independent financial consultants and attorneys to look at the issue, and those experts, along with the Governors Office, have been working collaboratively to ensure that post-integration, debt is appropriately apportioned between UMDNJ and Rutgers and that UMDNJ is stronger financially than it was prior to the higher education restructuring."

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Animal activist group files complaint against Primate Center

Harvard Medical School yesterday denied an allegation launched by an animal rights group that it failed to report another monkey death at its New England Primate Research Center.

In a March 20 letter to the U. S. Department of Agriculture, Michael Budkie, executive director of the Ohio-based animal rights organization Stop Animal Exploitation Now, says that a whistleblower connected to the center revealed details of a non-reported death at the facility.

Budkie said the whistleblower told him that a monkey died about seven months ago after a center employee performed a fairly routine medical procedure.

This can only mean that this procedure was clearly botched, and that the negligence which caused this cost the animal his/her life, Budkie wrote.

Budkie called for a thorough investigation of the death and for Harvard to be fined the maximum amount allowed by law. Individual violations of the Animal Welfare Act are punishable by fines of up to $10,000.

USDA spokesman Dave Sacks said yesterday that the complaint will be investigated in accordance with standard procedure.

We will do so by sending an inspector to this facility in the near future to conduct an inspection, he wrote in an email, adding that inspections are always unannounced so the exact date cannot be disclosed.

Suffice it to say, that because of the recent incidents at Harvards primate research center, it will be soon, he wrote. We will continue to closely monitor this facility by visiting more frequently as a way to monitor Harvards progress and ensure the welfare of the animals there.

Harvard self-reported a death at the facility that occurred on Feb. 26 the same day details of a separate monkey death came out in a USDA inspection report.

Four monkeys have died at the facility in the past two years, and three of those deaths have occurred since September. Fred Wang, who became interim director of the center in September, stepped down from the post shortly after the fourth death was announced, citing personal and professional reasons.

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Med school awaits accreditation results

For the last 22 months, the University of Minnesota Medical School has been gearing up for its accreditation review.

The last time the Medical School was accredited was in 2004. A medical school that has already been accredited usually goes through the process every eight years.

The school conducted a self-study review to see if the program met the Liaison Committee on Medical Educations standards for function, structure and performance.

The LCME oversees medical schools in the U.S. and Canada to make sure they are meeting the generalized standards.

Its an outstanding process that helps us understand ourselves a little better, said Associate Dean for Undergraduate Medical Education Kathleen Watson.

During an on-site visit by the LCME last week, the school was reviewed based on institutional setting, the educational program for the M.D. degree, medical students opinions, faculty and educational resources.

There were six groups involved in the self-study process, including a group of students.

More than 60 medical students from the Duluth and Twin Cities campuses were a part of the LCME Independent Student Analysis committee.

A survey conducted by the student committee asked students about their experiences in the Medical School to evaluate courses, teaching, exams and grading, said Heather Grothe, a fourth-year medical student on the committee.

The results were given to the Medical School, and Grothe said changes were made to fix unspecified problems.

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Medical school graduates getting jobs

University of Connecticut School of Medicine fourth-year students celebrated a successful Match Day on March 16, as 98.8 percent of students secured residencies around the country through the National Residency Match Program.

Only one student out of 88 failed to attain a residency, putting UConn well above the national match average of 95.1 percent. Dr. David Henderson, associate dean of medical student affairs, was said to have told the students in a UConn Today press release, This is, from an institutional perspective, a most excellent March Day. With nearly a 99 percent match rate, its about as close to perfect as you can get.

There was a 15 percent increase in students matched in primary care residency programs including internal medicine, family medicine and pediatrics. Compared to last years total of 35 percent, this year 50 percent of students attained matches.

The remaining 50 percent of students receiving residencies through Match Day entered such programs as emergency medicine, obstetrics/gynecology, orthopedic surgery and general surgery.

For current students, prospective medical students and faculty, this Match Day was very impressive. Thats a huge statistic; thats something huge for UConn, not just for the faculty and administration but for the students. Its good for current students but its also something good for future students to see, because it eases concerns about the work. Students can know theres an incentive at the end and their hard work will pay off. said Orest Paslavski, a 4th-semester biomedical engineering major and prospective medical student.

Fifty-six of the 88 students received placements in the Northeast, and 27 students will remain in Connecticut. Henderson said in UConn Today, The students worked really hard and accomplished a lot these past several years and were very pleased with the results.

Match Day is a yearly practice at medical schools across the nation that matches students with residency programs and fills available training positions at teaching hospitals around the country. This Match Day marks the 60th anniversary of the National Resident Matching Program, which was started in 1952. The next step for matched students? Working for their matched hospital after graduation.

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