Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map

May 16 - May 22, 2006

May 16th; BioElectronics Corporation Announces New 510(k) Market Clearance Application Filed With FDA

BioElectronics Corporation, (Pink Sheets: BIEL ), announced today that the company filed a 510(k) Market Clearance application for its new ActiPulse(TM) device with the Food and Drug Administration. ActiPulse(TM) requested indication for use is "the adjunctive use in the palliative treatment of post operative pain and edema in superficial soft tissue."

BioElectronics currently manufactures and sells ActiPatch(TM), a drug-free anti-inflammatory patch with an embedded battery operated microchip that delivers weeks of continuous pulsed therapy for less than a dollar a day. The unique ActiPatch delivery system, using patented technology, provides a cost- effective, patient friendly method to reduce soft tissue pain and swelling.

May 17th: FDA Approves New Treatment for Parkinson's disease

The Food and Drug Administration today approved Azilect (rasagiline), a new molecular entity, for the treatment of Parkinson's disease. The drug is a monoamine oxidase type--B (MAO-B) inhibitor that blocks the breakdown of dopamine, a chemical that sends information to the parts of the brain that control movement and coordination.

Azilect was approved for use as an initial single drug therapy in early Parkinson's disease, and as an addition to levodopa in more advanced patients. Levodopa is a standard treatment for Parkinson's disease. The safety and effectiveness of Azilect was demonstrated in three 18- to 26-week controlled clinical trials.

One of the studies compared the effects of Azilect with the effects of placebo in 404 patients with early Parkinson's. Compared with patients on placebo, the condition of patients on Azilect showed significantly less worsening on a rating scale that measures the ability to perform mental and motor tasks as well as daily living activities. The other two studies compared the effects of Azilect with placebo when taken together with levodopa by over 1100 patients with more advanced Parkinson's. In these studies, patients using Azilect together with levodopa had significantly less time per day with relatively poor function and mobility as compared with patients on levodopa and placebo.

Azilect is manufactured by Teva Pharmaceutical Industries in Tel Aviv, Israel.

May 19th: Boston Scientific and Lumenis to Market Trimedyne's New Fiber

Trimedyne, Inc. today announced it has entered into an agreement with Lumenis, Ltd. under which Trimedyne will manufacture the DuraMax(TM) Side Firing Laser Fiber exclusively for Lumenis. The DuraMax Fiber will be marketed by Boston Scientific Corporation under the Boston Scientific label in the United States. The new device will be used in conjunction with Lumenis' VersaPulse® PowerSuite(TM) Holmium Laser for holmium laser ablation of the prostate, known as HoLAP. HoLAP is a rapidly growing, minimally invasive technique for the treatment of benign prostatic hyperplasia, or BPH. Sometimes referred to as enlarged prostate, BPH is a condition affecting an estimated 50% of men over age 50 and up to 90% of men over 80 years of age.

In the U.S. alone almost 200,000 men with BPH are treated each year, many with an invasive surgical procedure known as a TURP or Transurethral Resection of the Prostate. With TURP, prostate tissue is cut into small pieces with an electrically heated wire loop, and the pieces are then flushed out with irrigating fluid. Patients treated with TURP commonly stay in the hospital 1-3 days, take longer than a week to recuperate, and experience bleeding during and after the procedure, resulting in up to 10% requiring a blood transfusion.

With HoLAP, prostate tissue is vaporized with holmium laser energy. This virtually bloodless procedure provides almost immediate symptom relief with fewer complications than typically seen with TURP. Patients are typically treated on an outpatient basis and quickly return to normal.
Based on laboratory testing on animal soft tissue, Trimedyne's new Fiber vaporizes an average of 3 to 4 grams of soft tissue per minute and lasts longer than required to treat a normal size prostate using 80 to 100 watts of holmium laser energy.

May 22nd: Boston Scientific and BioForm Medical announce FDA approval of Coaptite injectable implant.

Boston Scientific Corp and BioForm Medical Inc announced US Food and Drug Administration approval of BioForm Medical's Coaptite Injectable Implant for the treatment of female stress urinary incontinence. The companies also announced that they have signed an agreement giving Boston Scientific exclusive distribution rights for the Coaptite Injectable Implant in the US. The product is expected to launch in the US immediately. The Coaptite Injectable Implant is a next-generation bulking agent. The combination of calcium hydroxylapatite particles and the sodium carboxymethylcellulose carrier gel form a scaffold that promotes tissue infiltration. The Coaptite Injectable Implant particles are composed of the same components that are found in bone and teeth and are biocompatible. Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties.

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

Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map