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The Food and Drug Administration has granted marketing permission for a new micro catheter for peripheral vascular use to Micro Therapeutics, an Irvine, CA-based manufacturer of medical devices. According to George Wallace, president of Micro Therapeutics, the company is currently developing catheters of additional lengths for a range of applications.
In addition, the Rebar catheter will be a standard component of Micro Therapeutics’ ONYX Liquid Embolic System ONYX LES, a revolutionary treatment for brain aneurysms currently in feasibility trials in the United States and Europe. ONYX LES involves using Micro Therapeutics’ medical devices to reach vascular abnormalities. Once the delivery catheter is in position, ONYX, a liquid embolic material, is released and quickly transforms into a solid, yet flexible, polymer mass, filling the vascular defect. This enables blood to flow through the parent vessel with less risk of rupture and subsequent stroke.
Micro Therapeutics, founded in 1993, develops, manufactures, and markets medical devices that are minimally for the diagnosis and treatment of vascular disease. For further information, call Maureen Mazzatenta of Fischer & Partners at (310) 577-7870, ext. 103.
Sharps Compliance Corp., a manufacturer of systems for managing medical waste and infusion equipment, recently announced that it has developed a new concept in IV poles. The poles are the designed specifically for home health care patients receiving gravity- or pump-administered infusions.
The Pitch-It poles can eliminate the need for home health care nurses or drivers to transport and store large, bulky IV poles in their vehicles. The Pitch-It poles unfold in seconds and do not require any assembly. They are disposable and collapse to fit into any ordinary-size garbage container upon completion of treatment. The poles may also be recycled.
Pitch-It poles are available in tabletop, floor, and full-size models with wheels. The poles can support up to 3 liters of solution, and the full-size pole also accommodates an IV pump. Sharps president and CEO Burt Kunik, MD, says that the disposability of poles after use compliments the company’s mailback product line and will allow home health care companies to reduce the travel and labor costs associated with retrieving equipment after patient treatment is completed.
Sharps also offers a Disposal by Mail system to contain, transport, destroy, and track medical waste. The Houston-based company’s Trip LesSystem includes the Sharps Disposal by Mail System and either a disposable IV pole or an asset return box to accommodate any size infusion pump. For further information, call (800) 772-5657 or visit www.sharps.com.
A recent report issued by Express Scripts Inc. says that new prescription drugs, empowered consumers, and aging baby boomers had the most influence on pharmaceutical developments during the past year. The three factors led Express Scripts’ Top Ten list, compiled by a committee of Express Scripts pharmacists, physicians, and pharmacy benefit experts. The Top Ten developments were selected on the basis of their impact on providers of healthcare insurance and management of pharmacy benefit plans. Express Scripts is the nation’s leading independent, full-service pharmacy benefit management company.
The report points out that for the first time in history, patients are becoming participants in the prescribing process and cites direct-to-consumer advertising, media coverage and the Internet as creating more knowledgeable, more sophisticated consumers. "Of all that is occurring, perhaps no trend holds more profound implications for benefit design than the transformation of the American public into informed consumers of prescription drugs," says Barrett Toan, president and CEO of Express Scripts.
The report forecasts that greater public awareness will spur companies to include employees in discussions of the pharmacy benefits, stating, "Pharmacy benefit plan sponsors should anticipate that designing the pharmacy benefit to provide optimal choice will be the single greatest factor in employee satisfaction." An electronic version of the Express Scripts Top Ten, including clinical responses to each development, is available at www.express-scripts.com. For additional information, contact Ryan Soderstrom of Express Scripts, (612) 837-5160, or firstname.lastname@example.org.
The Food and Drug Administration has issued a letter to Texas Biotechnology Corp. saying that the company’s anticoagulant drug Novastan, an anticoagulant for prophylaxis or treatment of thrombosis in patients with heparin-induced thrombocytopenia (HIT), is approvable. The drug is a synthetic direct thrombin inhibitor that prevents clots from forming. It was developed for patients who can not continue to receive heparin. Clinical trials showed Novastan acts quickly and produces predictable anticoagulation levels. It also appears safe and is relatively easy to use.
HIT may affect as many as 300,000 Americans every year. The problem is caused by a paradoxical response to heparin, the most widely used blood thinner. SmithKline Beecham has codevelopment and marketing rights for Novastan. The drug is already in commercial-scale manufacture and presentation of the drug’s Phase III clinical trial results and medical education initiatives will occur soon.
An analysis of 34 million hospitalizations from the Health Care Financing Administration database shows over 10 million patients receive heparin in the United States annually. Medical literature suggests that HIT occurs in approximately 300,000 to 400,000 of U.S. heparin patients per year, although it is widely believed to be underdiagnosed.
John G. Kelton, MD, chairman of medicine at the McMaster University Faculty of Health Sciences, Ontario, and an expert in the area of heparin-induced thrombocytopenia, says, "HIT is a serious and life-threatening adverse reaction to heparin. The condition is caused by a complex immune reaction characterized by a strong tendency to clot that puts the patient at risk of major complications, such as heart attack and stroke, which can in turn, lead to amputation or even death." For more information, contact Pamela Murphy, vice president of Texas Biotechnology Corporation, at (713) 796-8822.
Subsidiary Pyng Medical Corp. has signed production designs and drawings for a new intraosseous infusion system for adults. The F.A.S.T.1 System for Adult Intraosseous Infusion, designed, developed, patented, and trademarked by Pyng Medical Corp., has Food and Drug Administration approval and is the first I/O System for sternal access on the market. Extensive field trials across North America showed that the F.A.S.T. will allow emergency caregivers to achieve safe, assured central vascular access in 60 seconds or less in shock and trauma victims when conventional methods fail. The manufacturer says that the F.A.S.T.1 economical design used computer analysis, specialized plastic selection, and "snap-fit" assembly. Pyng reports receiving more than 1,400 pre-manufacture inquiries about the system. For further information, contact Michael W. Jacobs at Subsidiary Pyng (800) 349-7964 or visit www. pyng. com.
St. Paul, MN-based SIMS Deltec Inc. has announced development of a new drug delivery system for trans-arterial percutaneous (TAP) delivery of regional chemotherapy to treat metastases of colorectal liver cancer.
The company’s Port-a-Cath II TAP implantable access system is designed for hepatic arterial infusion of chemotherapy. It uses a portal implanted in the chest and a catheter that is threaded along the axillary to the hepatic artery to the liver, which is a day hospital procedure with local anesthesia.
The system requires a minimally invasive surgical procedure and allows a high drug concentration to the target area while keeping systemic toxicity low. The manufacturer says the system also minimizes trauma and cost.
The company manufactures a wide range of infusion and access systems for domestic and international markets. For additional information regarding SIMS Deltec, visit Deltec’s Web site at www.deltec.com, or call (651) 628-7248.