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September 12 – September 18 

September 12th: Endocare Receives FDA 510K Clearance to Market New Nitrogen-Based Cryoablation System for Destroying Tissue and Cancerous Tumors

Endocare, Inc. an innovative medical device company focused on the development of minimally invasive technologies for tissue and tumor ablation, announced today that it has received 510K clearance from the U.S. Food and Drug Administration to market its new Cryocare CN2 System, a potentially much faster and easier-to-operate cryoablation system for freezing cancerous tumors and tissue. This new system uses nitrogen as the freezing and tumor-destroying element. The nitrogen, called "critical nitrogen" because it works in a unique form at the critical point where gas nearly becomes liquid, is also more powerful and more readily available in surgical suites than argon, the freezing element in Endocare's current market-leading cryoablation systems.

This proprietary Cryocare CN2 System represents a significant advancement in cryoablation because it is more powerful and can get the tumor-ablating job done faster and more effectively than current systems using argon. The nitrogen technology may drive more widespread adoption of cryoablation internationally given that, in many countries, nitrogen is more readily available and less expensive than argon. We believe that the Cryocare CN2 System is the cryoablation system of the future and in the near term should supplant many of the older systems used by our interventional radiology and oncology customers for addressing liver, lung and bone cancers."

Cryoablation, as a treatment for cancer and its symptoms, has become an important and often used tool for urologists and interventional radiologists. Domestically, through the first six months of 2006 almost 3,700 patients with prostate, renal and other cancers were treated with cryoablation, compared with less than 1,600 procedures performed in all of 2001. In addition, the clinical data demonstrate that cryoablation is a very efficacious treatment for killing cancer and yet, potentially provides the patient with less morbidity and side effects than other cancer treatments for kidney, lung and liver cancers. Also, cryoablation is currently being studied for the alleviation of bone pain associated with bone cancers.

Endocare, Inc. is an innovative medical device company focused on the development of minimally invasive technologies for tissue and tumor ablation. Endocare has initially concentrated on developing technologies for the treatment of prostate cancer and believes that its proprietary technologies have broad applications across a number of markets, including the ablation of tumors in the kidney, lung and liver.

September 13th: Uroplasty Receives PMA Approvable Letter for Macroplastique

Uroplasty, Inc. announced today that it has received an approvable letter from the U.S. Food and Drug Administration (FDA) relating to its pre-market approval (PMA) application for Macroplastique® Implants for the treatment of female stress urinary incontinence (SUI).

The receipt of the approvable letter follows FDA's completion of the scientific review of the safety and efficacy of Macroplastique. The FDA determined that the PMA is approvable subject to Uroplasty's manufacturing facilities, methods and controls being audited by the FDA and in compliance with applicable Quality System Requirements. The FDA is currently auditing Uroplasty's manufacturing facilities in Minneapolis, Minnesota and Eindhoven, The Netherlands.

Macroplastique is already a market leader and a preferred treatment outside the U.S. for SUI resulting primarily from intrinsic sphincter deficiency. Since its introduction in Europe, over 60,000 people have been treated with Macroplastique and numerous clinical publications reinforce the safety and efficacy of this product.

Uroplasty's patented Macroplastique is a soft tissue, injectable bulking agent for use in a minimally-invasive, out-patient procedure to treat female SUI which primarily results from intrinsic sphincter deficiency. SUI is the most common type of urinary incontinence and affects approximately 13 million Americans, 85% of whom are women. SUI is described as the sudden, accidental loss of urine during normal, everyday activities such as sneezing, coughing, laughing, straining or lifting items. Fifteen percent of the individuals with SUI suffer from a condition called intrinsic sphincter deficiency -- a condition in which certain muscles circling the urethra weaken and can no longer properly close to hold urine. When a physician injects Macroplastique into the tissues surrounding the urethra, the increased "bulk" allows the urethra to close more effectively and prevents urine from leaking.

Uroplasty, Inc., headquartered in Minnetonka, Minnesota, with wholly-owned subsidiaries in The Netherlands and the United Kingdom, is a medical device company that develops, manufactures and markets innovative, proprietary products for the treatment of voiding dysfunctions, including urinary and fecal incontinence, overactive bladder and vesicoureteral reflux.

September 15th: ETHICON Introduces New, Advanced Device for Laparoscopic Hysterectomy

ETHICON Women's Health and Urology announces the availability of the GYNECARE MORCELLEX* Tissue Morcellator, an advancement in tissue morcellation that facilitates laparoscopic supracervical hysterectomy (LSH). The new device is engineered to provide surgeons with a fast, precise morcellation tool that delivers enhanced performance and efficiency.

Unlike a traditional hysterectomy, which involves the removal of the uterus through a large abdominal incision, LSH removes only the uterus (and sometimes the fallopian tubes and ovaries) and preserves the cervix. The GYNECARE MORCELLEX device is an important component used during the LSH procedure. It allows the surgeon to morcellate the tissue of the uterus and extract it through small abdominal incisions. Advancements in the engineering of this device allow tissue morcellation to take place more effectively and at a rate four times as fast as the current ETHICON product offering. The easy-to-use design minimizes setup time, and a more durable titanium-coated blade speeds tissue morcellation.

Each year approximately 600,000 women in the United States undergo a hysterectomy, making it the most common, non-pregnancy related surgery performed on women. In fact, more than one-fourth of U.S. women will have a hysterectomy by the time they are 60 years old. Compared to traditional hysterectomy, LSH has the potential to offer the patient less pain, minimal scarring, and a faster return to normal activity.

During the LSH procedure, a doctor inserts a thin, lighted telescope-like instrument called a laparoscope, which acts like a video camera, and small surgical instruments through three to four tiny incisions in the navel and abdomen. Using the instruments, the surgeon carefully separates the uterus from the cervix and removes it through one of the openings. The cervix is left intact. The GYNECARE MORCELLEX device can also be used to facilitate laparoscopic myomectomy.

As with all surgery, hysterectomy involves risks, including potential blood loss, infection, and damage to other internal organs.

ETHICON Women's Health and Urology is dedicated to providing innovative, minimally invasive treatments for common urologic and women's health conditions. The division offers solutions for enlarged prostate (benign prostatic hyperplasia); female stress urinary incontinence; pelvic floor repair; post-surgical adhesions; heavy periods (menorrhagia); and benign uterine conditions, such as fibroids and polyps. ETHICON Women's Health and Urology is a division of ETHICON, Inc., a Johnson & Johnson company.

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