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April 11 – April 17

April 11th: Abbott Receives European Commission Clearance for Acquisition of Guidant's Vascular Business

Abbott announced today that the European Commission has cleared its proposed acquisition of Guidant's vascular business. The proposed transaction is also currently under review by the U.S. Federal Trade Commission.

Abbott is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritional products, devices and diagnostics. The company employs 60,000 people and markets its products in more than 130 countries.

April 12th: Sicel Technologies Receives 510(k) Clearance for DVS(R), the First Implantable Radiation Sensor for Use in Treating Cancer

Sicel Technologies, Inc., announced today that DVS® (Dose Verification System), its wireless, implantable radiation sensor and reader has received 510(k) clearance from the U.S. FDA. FDA clearance was based upon successful completion of a multi-center clinical study of breast cancer patients most of who were implanted with two DVS® sensors prior to receiving radiation therapy. Using the hand held reader; physicians were able to determine the actual dose of radiation being delivered to the tumor after each course of therapy. Implantation of the DVS® sensor did not lead to any adverse events in the clinical trial.

DVS® is the first permanently implantable, wireless, telemetric, radiation sensor for human use to be commercially available in the United States. Deviations in dose received by the tumor, or accidentally administered to normal tissue, can have a serious impact on long term survival rates and quality of life for the more than 650,000 patients treated annually with radiation therapy. The Company anticipates expanding the indications for DVS to allow its use in the treatment of other cancers. To that end Sicel has completed a study of patients being treated for prostate cancer and anticipates filing this data with the FDA in the near future. Breast and prostate cancer are the second leading causes of cancer related deaths in the U.S. afflicting over four hundred thousand people a year.

April 14th: Customized Optical Device Helps Dentists to Detect Oral Cancer

Researchers supported by the National Institute of Dental and Craniofacial Research, part of the National Institutes of Health, report today their initial success using a customized optical device that allows dentists to visualize in a completely new way whether a patient might have a developing oral cancer.

Called a Visually Enhanced Lesion Scope (VELScope), this simple, hand-held device emits a cone of blue light into the mouth that excites various molecules within our cells, causing them to absorb the light energy and re-emit it as visible fluorescence. Remove the light, and the fluorescence of the tissue is no longer visible.

Because changes in the natural fluorescence of healthy tissue generally reflect light-scattering biochemical or structural changes indicative of developing tumor cells, the VELScope allows dentists to shine a light onto a suspicious sore in the mouth, look through an attached eyepiece, and watch directly for changes in color. Normal oral tissue emits a pale green fluorescence, while potentially early tumor, or dysplastic, cells appear dark green to black.

Testing the device in 44 people, the results of which are published online in the Journal of Biomedical Optics, the scientists found they could distinguish correctly in all but one instance between normal and abnormal tissue. Their diagnoses were confirmed to be correct by biopsy and standard pathology.

April 16th: First Optimizer(TM) Implant in the State Of Illinois - Device for Treatment of Heart Failure

Impulse Dynamics today announced that the first implant of its proprietary medical device for the treatment of heart failure called the Optimizer was successfully performed by Dr. Moeen Saleem, Midwest Heart Specialists Electrophysiologist at Edward Heart Hospital in Naperville, Illinois. This procedure is part of the FIX-HF-5 clinical study. Midwest Heart Foundation is a clinical trial site and Dr. Maria Rosa Costanzo, Midwest Heart Specialists Cardiologist, is the principle investigator for the study.

The Optimizer System is designed to deliver electrical impulses to the heart for treatment of moderate to severe heart failure. This study of the Optimizer System is sponsored by Impulse Dynamics (USA) Inc., a specialty medical device company located in New York and a wholly-owned subsidiary of Impulse Dynamics N.V.

Heart failure is a disease that afflicts over 5 million Americans and an estimated 15 million patients worldwide. It is one of the most common causes of hospitalization and a growing and costly burden to the healthcare system. It is estimated that the U.S. healthcare system will spend a projected $28.9 billion on caring for heart failure patients in 2006.

The investigational study, called FIX-HF-5 (Fix Heart Failure 5), is designed to investigate the effects of the Optimizer System in approximately 400 New York Heart Association (NYHA) Class III or Class IV heart failure patients at up to 50 U.S. sites.

If you have any comments regarding this update, please email: info@mdiconsultants.com

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