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April 25th – May 1

April 25th: FDA Approves Humanitarian Device Exemption for Instrument Set to Treat Rare Disorder Affecting Fetal Twins -- KARL STORZ Device Offers Unique Treatment Option for Twin-to-Twin Transfusion Syndrome

Karl Storz Endoscopy-America, Inc., a world leader in diagnostic and operative minimally invasive endoscopic technology, announces that the Food and Drug Administration (FDA) has approved a Humanitarian Device Exemption (HDE) for the company's Fetoscopy Instrument Sets used for selective laser photocoagulation (S-LPC) to treat fetuses with twin-to-twin transfusion syndrome (TTTS), a rare disorder of the placenta that affects identical twin pregnancies. In TTTS, blood can flow unevenly between the fetal twins, with one receiving too much blood while the other receives too little.

"KARL STORZ is now the only medical device manufacturer in the U.S. that will offer an FDA HDE-approved product for treating TTTS," says Thomas Prescher, Ph.D., Director of Marketing, Gynecology/Video, KARL STORZ. "Using the Fetoscopy Instrument Set, physicians may be able to prolong the pregnancy to improve the odds of survival and reduce the likelihood of complications for one or both twins. FDA's approval of the HDE for our product provides a vital option for surgeons encountering TTTS. It also offers hope for the parents of twins with this condition."

The KARL STORZ Fetoscopy Instrument Sets will be marketed under the FDA's Humanitarian Use Device (HUD) program, which encourages development of medical devices intended to treat or diagnose a disease or condition affecting fewer than 4,000 people in the U.S. per year. To receive approval to market an HUD, the applicant must demonstrate the safety and probable benefit of its device. Such products can only be used under the supervision of a local Institutional Review Board. The Fetoscopy Instrument Set is only the 38th product that the FDA has approved for marketing as a humanitarian use device.

April 26th: Medicare Proposes Competitive Acquisition Program for Certain Durable Medical Equipment, Prosthetics, Orthotics and Supplies

The Centers for Medicare & Medicaid Services (CMS) today issued a proposed rule to improve Medicare's payments for certain durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) through a new competitive acquisition program. This proposal would reduce beneficiary out-of-pocket expenses and save the Medicare program money while ensuring beneficiary access to quality DMEPOS items and services.

The new competitive acquisition program, which is required by the Medicare Modernization Act of 2003 (MMA), would replace the current DMEPOS fee schedule payment amounts for selected items in select areas. CMS has discretion under the law to first phase in DMEPOS items for bidding based on high cost and volume or largest savings potential. Suppliers in a competitive bidding area would submit bids for selected items, and CMS would use these bids to establish Medicare payment amounts for these items. Under the proposed rule, the Medicare payment amounts would be the median of the winning suppliers' bids for selected items. Suppliers whose bids are lower than the Medicare payment amounts set under the competitive bidding program could offer a rebate to beneficiaries, lowering their costs for acquiring the DME items they need. Within five years of implementing the competitive bidding programs, savings to taxpayers are expected to exceed over $1 billion annually.

April 27th: Kensey Nash Receives FDA 510(k) Clearance for New ThromCat(TM) Thrombectomy Catheter System

Kensey Nash Corporation today announced that it has received 510(k) clearance for its ThromCat(TM) Thrombectomy Catheter System from the U.S. Food and Drug Administration (FDA). The ThromCat(TM) System is a Thrombectomy catheter designed to remove thrombus or blood clots from a patient, with an initial indication for use in AV grafts and fistulas. The Company plans to study the utility of the device for application in additional vessels in the coming year.

The ThromCat(TM) device is a fully disposable catheter system that incorporates HeliFlex(TM) technology to flush, macerates, and extract thrombus. An internal rotating helix creates a powerful vacuum to draw thrombus into the catheter and then macerates it, while simultaneously flushing the vessel to aid in the thrombus removal. According to industry sources, the current market for Thrombectomy catheter systems approximates $100 million worldwide, including the coronary market.

Kensey Nash Corporation is a leading medical technology company providing innovative solutions and technologies for a wide range of medical procedures. The Company provides an extensive range of products into multiple medical markets, primarily in the endovascular, sports medicine and spine markets. Recently, the Company has created an endovascular division to launch its novel TriActiv® Embolic Protection System, a device designed to prevent debris from traveling downstream from the treatment site during stenting procedures. Kensey Nash is bringing several versions of the device to market, including the TriActiv FX® and TriActiv® ProGuard(TM) Systems.

May 1st: Medtronic Receives FDA Approval for Micro-Driver Stent

Medtronic, Inc. (NYSE:MDT ) said today that it has received U.S. Food and Drug Administration approval for the Micro-Driver coronary stent system, a bare metal system designed specifically to perform in small vessels and tortuous anatomies. This cobalt alloy stent is the first bare metal stent for small vessels with an indication for new or untreated vessels (a de novo indication), addressing an important need in the treatment of coronary artery disease.

Based on the popular Medtronic Driver® stent platform, the Micro-Driver stent has a rounded, modular design for excellent deliverability. The ultra-low crossing profile helps physicians access the difficult-to-reach lesions often encountered in patients with small vessels.

Even with the rapid acceptance of drug-eluting stents (DES) during the last three years, bare metal stents still play a critical role in the medical practice of interventional cardiologists. Many physicians choose bare metal stents for patient care in small-vessel cases, and the Micro-Driver stent offers them an important treatment option.

"A stent can be effective only if it gets to the lesion. Micro-Driver is highly deliverable and is designed specifically for ease-of-use in these types of patients," said Sean Salmon, Medtronic vice president and General Manager of Medtronic Vascular coronary business. "We believe there always will be an important role for bare metal stents, especially when they can address specific clinical needs as this stent does." Medtronic, Inc, headquartered in Minneapolis, is the global leader in medical technology - alleviating pain, restoring health, and extending life for millions of people around the world.

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

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