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September 5 – September 11 

September 5th: ETHICON Introduces New Device to Treat Stress Incontinence

ETHICON Women's Health & Urology will announce at the annual meeting of the International Urogynecological Association (IUGA) this week that the GYNECARE TVT SECUR* System is available for use to treat female stress urinary incontinence (SUI). This new midurethral sling device maintains the elements that made GYNECARE TVT the gold standard in SUI repair, yet offers a small, innovative design that facilitates a less invasive treatment approach and eliminates patient discomfort associated with skin exits.

GYNECARE TVT SECUR features a PROLENE* Polypropylene Mesh implant that is four times shorter in length than traditional slings. The mesh tape is introduced to the patient using a novel "attach and release" mechanism that allows for stable and controlled placement, resulting in no skin exits. Absorbable fixation tips made of Vicryl* (polyglactin 910) knitted mesh and PDS* (polydioxanone) suture yarn provide mechanical fixation until complete tissue ingrowth occurs. The device is designed for use in a 10- to 15-minute procedure that can be used with local anesthesia.

The GYNECARE TVT SECUR System uses the same unique PROLENE Mesh used in over one million patients worldwide, and has been proven safe and effective with seven years of clinical data. The mesh is inserted through the vagina and positioned underneath the urethra, creating a supportive sling. During movement or exercise, the mesh supports the urethra, allowing it to maintain its seal to prevent urine loss. The tape provides support only when needed, without any unnecessary tension on the urethra (tension-free).

The treatment is not intended for women who are or intend to become pregnant. Women on anticoagulation therapy also are not candidates.

The family of GYNECARE TVT products is marketed by ETHICON Women's Health & Urology, a division of ETHICON, INC., a Johnson & Johnson company.

September 6th: Abiomed Receives FDA Approval of the AbioCor(R), the World's First Completely Self-Contained, Implantable Artificial Heart

Abiomed, Inc. announced today it has received Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) for its AbioCor® Implantable Replacement Heart (AbioCor). This landmark approval will provide patients suffering from heart failure on both sides of their heart (bi-ventricular) and who have no other alternative, a viable option for extending the quality of their life. The AbioCor is the first completely self-contained artificial heart that may allow patients more time at home, without wires or tubes piercing through their skin. This technology provides patients with complete mobility and remote diagnostics.

The AbioCor system consists of: a two-pound mechanical heart that takes over the pumping function of the diseased heart, which is removed during the implantation procedure; a power transfer coil that powers the system across the skin and recharges the internal battery from the outside; and a controller and an internal battery, which are implanted in the patient's abdomen. The controller monitors and controls the functioning of the device, including the pumping rate of the heart. The internal battery allows the recipient to be free from all external connections for up to one hour. The system also includes two external batteries that allow free movement for up to two hours. During sleep and while batteries are being recharged, the system can be plugged into an electrical outlet.

In order to receive the artificial heart, in addition to meeting other criteria, patients must undergo a screening process to determine if their chest volume is large enough to hold the device.

The FDA decision was completed after extensive review of the clinical testing, beginning with clinical trials starting in 2001 under an Investigational Device Exemption (IDE). The AbioCor would be available under an HDE to a limited patient population in the United States under this approval, with no more than 4,000 patients receiving the technology each year. In order to ensure the highest standards of patient care, Abiomed intends to make the AbioCor available through a controlled roll-out at approximately five to ten heart hospitals in the United States, including qualified clinical trial sites and additional qualified centers once they have completed a comprehensive and rigorous training program which may take six to eight months. Under HDE approval, the FDA may request a panel review of the post-approval study data. In addition, Abiomed is working with the Centers for Medicare and Medicaid Services (CMS) and private insurers to establish reimbursement policies for the AbioCor.

Devices approved under the HUD provisions are those intended to treat conditions or diseases that affect fewer than 4,000 people a year in the United States. Similar to the Orphan Drug Act, the HUD provisions was designed to encourage development of innovative medical devices to treat rare conditions. It allows medical devices to be approved for market if they demonstrate safety and probable benefit.
Abiomed continues to develop next-generation total artificial heart technology, the AbioCor II, in order to provide life-saving circulatory support to more patients in bi-ventricular heart failure. Currently in preclinical evaluation, this technology has the potential to last up to five years and is approximately 30 percent smaller than the AbioCor.

September 11th: Medical Action Industries Agrees to Acquire Medegen Medical Products LLC

Medical Action Industries Inc. a leading supplier of medical and surgical disposable products, today announced that it has agreed to acquire Medegen Medical Products LLC ("Medegen Medical"). Medegen Medical, which maintains manufacturing facilities in Colorado and Tennessee, is the market leader in the manufacture of plastic patient utensils consisting of wash basins, bed pans, urinals and emesis basins. This acquisition will be Medical Action's tenth and is by far the most significant acquisition in the Company's history. Medegen Medical has annual revenues of approximately $100,000,000 and will continue to operate out of its current facilities after closing. The purchase price of approximately $80,000,000 will be payable in cash, funded from cash on hand, together with borrowings from lending institutions.

Paul D. Meringolo, Chief Executive Officer and President of Medical Action, commented, "This transaction, which is expected to close in approximately 45 days will be accretive to earnings immediately. This acquisition further diversifies our breadth of product offering to our existing customers, as well as adding customers outside of our current channels of distribution. The combination of expanded contracts, increased volumes and strategic product line extensions will all lead to increased synergies for Medical Action."

Medical Action is a diversified manufacturer of disposable medical devices. Its products are marketed primarily to acute care facilities in domestic and certain international markets. Further, Medical Action has expanded its target market to include physician, dental and veterinary offices, out-patient surgery centers and long-term care facilities. Medical Action is a leading manufacturer and distributor of many of its products in the markets we compete in. Our products are marketed through an extensive network of direct sales personnel and independent distributors. Medical Action has preferred vendor agreements with national distributors, as well as contracts with nearly every major group purchasing alliance. The Company's common stock trades on the NASDAQ Global Select Market under the symbol MDCI and is included in the Russell 2000 Index.

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