Medical equipment industry
A 72-year-old man from Chicago has made history as the first person in the nation to receive the HeartMate II LVAS for ongoing, permanent support of his failing heart. Developed by Thoratec Corporation, the device is a groundbreaking innovation in the treatment of heart failure, offering a smaller and more
Medical equipment industry
Advocate Christ Medical Center has announced that a 72-year-old Chicago man has become the first person to be permanently supported by the HeartMate II LVAS (Left Ventricular Assist System) for ongoing treatment of late-stage heart failure. The patient received the implantation on March 21 as part of a US phase
Medical equipment industry
Staff writer Chris North spent most of her young life struggling with bulimia, but a new treatment involving a pacemaker-like device implanted in her chest brought her immediate improvement and has not suffered a bulimic episode since July 30. Key Takeaways: * Neurostimulation devices, which deliver mild, regularly timed pulses to
Medical equipment industry
Hytek Microsystems, Inc., a leader in hybrid microelectronic circuits, today announced its fiscal 2005 first quarter financial results, which saw a net loss of $2,000, or $0.00 per diluted share, compared to net income of $60,000, or $0.02 per diluted share, for the first quarter of
Medical equipment industry
Mentor Corp's silicone gel breast implants have cleared marketing clearance from the US Food and Drug Administration (FDA), although with conditions attached, in a move that contrasts with the rejection of a similar application by competitor Inamed Corp. The FDA's General and Plastic Surgery Devices Advisory
Medical equipment industry
Spinal implant manufacturer Archus Orthopedics Inc has received an Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) for its total facet arthroplasty system (TFAS), designed to treat spinal stenosis. The device, which replaces degenerative facet joints with a prosthetic joint implant, aims to restore stability and
Medical equipment industry
Boston Scientific Corporation (BSX) has obtained approval from the U.S. Food and Drug Administration (FDA) for its Quincy Distribution Center as a sterilization site for its Cutting Balloon microsurgical dilatation device product line. The company's Letterkenny, Ireland facility has also received FDA approval to manufacture two versions
Medical equipment industry
Boston Scientific Corporation has completed enrollment in its 3-year Enteryx Procedure clinical trial, designed to analyze the safety and efficacy of the procedure for patients with gastroesophageal reflux disease (GERD) symptoms. The study has enrolled over 300 patients at 28 U.S. sites, building on the Enteryx Procedure's
Medical equipment industry
After a 13-year ban, a Food and Drug Administration advisory panel has approved the sale of silicone breast implants manufactured by Mentor, a move that has improved the chances for more implants to re-enter the market. Industry analysts say the decision has opened the door for other companies to follow
Medical equipment industry
The Food and Drug Administration's advisory panel voted 7-2 to recommend approval of Mentor's application to sell its silicone-gel implants to any woman who wants them. This decision marks a significant step towards the return of the implants to the U.S. market, which has been
Medical equipment industry
The US Food and Drug Administration (FDA) has approved enhancements to the Directions for Use (DFU) of the TAXUS(R) Express(2)(TM) paclitaxel-eluting coronary stent system, allowing patients to undergo Magnetic Resonance Imaging (MRI) examination immediately following implantation. This is the first drug-eluting stent to receive approval for immediate
Medical equipment industry
Boston Scientific Corporation has begun enrolling patients in a significant registry to evaluate the efficacy and safety of its new Taxus Liberte paclitaxel-eluting stent system. The Taxus OLYMPIC registry will enroll more than 30,000 patients at over 600 centers across the United States, Europe, and other international locations. This
