A Medical Device Daily

The National Patient Safety Foundation (NPSF; McLean, Virginia), a non-profit organization focused on improving patient safety and reducing medical errors, reported two grant recipients to carry out research highlighting patient safety initiatives in occupational therapy and community-based patient education.

The NPSF Research Program joined with the American Medical Association (Chicago) to support the grant, “Improve Patients' Safety: Learning Model to Reduce Errors in Occupational Therapy and Physical Therapy Practice.“ The $99,705 grant award is for study aimed at understanding the phenomenon of practice errors in occupational and physical therapy, exploring preventive strategies, developing a learning model and disseminating educational materials designed to improve patient safety.

NPSF's second grantee is a team from the Department of Medicine of the University of Cincinnati. The team has been awarded $99,878 for its study, “Community-based Patient Safety Education for the Elderly.“ The study will investigate a community-based, patient safety intervention for independent living elderly. The hypothesis is that the intervention will lead to an increase in patient safety self-advocacy knowledge and skills and an increase in their use in the outpatient setting.

Since 1998, the National Patient Safety Foundation Research Program has supported 23 research projects with more than $2 million in grant funding.

In other grants/contracts news:

• Alerion Biomedical (San Diego), in collaboration with the Vanderbilt University Medical Center (Nashville, Tennessee), was awarded a National Institutes of Health (NIH; Bethesda, Maryland) small business technology transfer grant for their project titled, “MRI with Protease-Sensing Contrast Agents.“

Lynn Matrisian, PhD, of the Vanderbilt-Ingram Cancer Center at the medical center, is the principal investigator for the study. Matrisian is an internationally recognized expert in the molecular mechanisms that underlie cancer development, growth and metastasis.

The goals of the STTR project include designing, synthesizing and testing a new class of biochemically activated magnetic resonance imaging (MRI) contrast agents that detect and monitor disease-associated enzymatic activity in vivo. The success of the project has the potential for improved non-invasive detection and evaluation of cancer.

“Our project is based upon the hypothesis that the activation of MRI contrast agents by extracellular proteases represents a particularly promising strategy to detect and image biochemical processes relevant to cancer,“ said Matrisian. “Our goal is to determine if tumor-associated matrix metalloproteinase activity can be non-invasively imaged by MRI.“

Dr. William Dow, Alerion's vice president of R&D, said, “This partnership has the potential to yield MRI contrast agents that will improve the way we detect and stage cancer, as well as provide new tools for the assessment of experimental therapies for cancer treatment.“

Alerion develops technologies for improving the detection, treatment and monitoring of disease processes at the molecular level.

Lifecore renews Alcon agreement

Lifecore Biomedical (Chaska, Minnesota) reported that it has renewed its supply agreement with Alcon (Fort Worth, Texas), a global eye care company. Lifecore supplies hyaluronan to Alcon, a leader in ophthalmic products, for use in Viscoat Ophthalmic Viscoelastic Solution, an aid in anterior segment surgical procedures including cataract extraction and intraocular lens implantation. The new agreement extends through December 2008 and retains minimum purchase commitments and other features of the previous agreement.

“Renewal of the agreement continues [our] 20-year relationship with our largest customer and a leader in the ophthalmic market,“ said Lifecore president and CEO Dennis Allingham. “We are pleased that the renewal term has increased to four years from the customary two years.“

Lifecore manufactures biomaterials and medical devices for use in surgical markets through two divisions: its Hyaluronan Division conducts its business through OEM and contract manufacturing alliances in the ophthalmic, orthopedic, veterinary and gynecologic surgical fields; its Oral Restorative Division conducts its dental surgery business through direct sales and marketing in the U.S., Germany, Italy, and Sweden, and via 25 distributors in 35 countries.

Briefly Noted

American Medical notified of corrected RVU

American Medical Systems Holdings (Minneapolis) said it has been informed by the Center for Medicare & Medicaid Services (CMS; Baltimore) of the corrected 2005 non-facility relative value units (RVUs) for the company's Her Option in-office cryoablation therapy. The total non-facility RVUs for CPT code 58356 in 2005 are about 68.65, resulting in a national average Medicare allowable payment of $2,602. The corrected RVUs and corresponding payment were effective as of Jan. 1.

The 2005 Medicare Physician Fee Schedule, published on Nov. 15, incorrectly reported the non-facility RVUs for CPT code 58356. The American College of Obstetricians and Gynecologists (Washington) worked with CMS during the past few months to ensure that the values for in-office endometrial cryoablation were corrected and updated in time for 2005.

Marty Emerson, president and CEO of AMS, said, “This new code will facilitate physician billing and reimbursement for this proven office treatment, allowing significant patient benefits and real cost savings to the healthcare system.“

CMS payments increase for EECP therapy

Vasomedical (Westbury, New York), which focuses on the non-invasive treatment and management of cardiovascular diseases, reported that changes to the Physician Fee Schedule for 2005 published recently by the Centers for Medicare & Medicaid Services will result in a new national average payment level of $138.34 per session for EECP therapy. The new average payment for physicians reflects a 10.9% increase for enhanced external counterpulsation (EECP) therapy over the earlier proposed 2005 rate of $124.69. The national average reimbursement rate for EECP therapy administered in the hospital outpatient setting of $102.18 reflects a 3% decrease over the earlier proposed rate of $105.38.

Vasomedical's EECP systems are comprised of an air compressor, a computer console, a set of cuffs and a treatment table. In a treatment, patients lie on the table, their calves and lower and upper thighs wrapped in the cuffs. The system, which is synchronized to the individual patient's cardiac cycle, inflates the cuffs with air to create external pressure when the heart is resting (diastole) and deflates the cuffs just before the heart beats (systole).

The system's action, which pulses counter to the heart's beating, increases blood flow to the heart muscle, decreases the heart's workload and creates a greater oxygen supply for the heart muscle while lowering the heart's need for oxygen, the company said.

Treatment typically is given in 35 one-hour-sessions over seven weeks. Vasomedical said the benefits have been shown to persist for years.

Abiomed launches service for heart recovery

Abiomed (Danvers, Massachusetts), maker of medical products designed to assist or replace the pumping function of the failing heart, reported the launch of an education and service program designed to promote heart recovery. The program combines clinical training, web-based education, process improvement, and field service.

“By providing clinical support and education on best practices including early implantation, time on support, and reducing bleeding, we can help our hospitals improve outcomes,“ said Michael Minogue, CEO and president of Abiomed. “Our goal is to give our customers the tools they need to help acute patients recover and go home with their own hearts.“

The program includes web-based learning modules developed by eTrinsic (Louisville, Colorado) that will enable clinical teams to be trained on the AB5000 and BVS 5000 using an interactive course that simulates the clinical experience. “By combining leading-edge educational process and technology, the course simulates important aspects of this procedure so that clinicians and other healthcare professionals can now learn in a risk-free environment that is both compelling and realistic,“ said Jacques Devaud, CEO and president of eTrinsic. “Our goal is improved outcomes, and we are pleased to have participated in this project with Abiomed.“

The course also will share the techniques and practices that have been shown to promote survival and recovery at Abiomed's top centers. For instance, at the top 20% of centers in the company's installed base, the survival rate for patients implanted with Abiomed's ventricular assist devices is greater than 50%.

eTrinsic develops e-learning content using simulation and tracking technology, called True Learning Experiences, for medical device and equipment, life science and healthcare organizations worldwide.

Milestone not in AMEX compliance

Milestone Scientific (Livingston, New Jersey) reported being notified by the American Stock Exchange (AMEX) that it is not in compliance with the $6 million minimum shareholders' equity requirement for continued listing. In its quarterly report on Form 10-Q for the period ended Sept. 30, 2004, the company reported shareholders' equity of about $5 million. AMEX has requested that the company provide information as to how it intends to regain and sustain compliance with this requirement, and the company said it is cooperating with that request.

Milestone manufactures the CompuMed and CompuDent computer-controlled local anesthetic delivery systems for medical and dental applications. The company recently reported its entry into the consumer tooth-whitening market via the licensing of its proprietary CoolBlue system to a third-party, mass-marketing organization.

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