Medical equipment industry
Novation, the supply company of VHA Inc. and the University HealthSystem Consortium (UHC), has signed agreements with Guidant Corp. and Medtronic USA Inc. for cardiac rhythm management products, equipment, and accessories. The contracts cover implantable pacemakers and defibrillator systems, heart failure systems, and temporary pacing and leads. The agreements were
Medical equipment industry
Guidant Corporation, a leader in the treatment of cardiac and vascular disease, has announced the next phase of its ADVANCENT national registry to study left ventricular dysfunction (LVD). The ADVANCENT 'in Practice' edition will focus on helping physicians identify patients who could benefit from advanced treatment options by
Medical equipment industry
Northstar Neuroscience, a privately held developer of medical devices for the treatment of neurological diseases and disorders, has secured a series E financing from Boston Scientific Corporation. This funding will be used to initiate a pivotal clinical trial in the U.S. for its investigational stroke recovery system and for
Medical equipment industry
Medtronic, a leading medical technology company, announced the appointment of Terrance (Terry) Carlson as senior vice president, general counsel and corporate secretary, effective October 1, 2004. This appointment marks a significant milestone in Medtronic's efforts to strengthen its legal and government affairs functions. Carlson brings a wealth of
Medical equipment industry
EP MedSystems, a developer of electrophysiology products, has received regulatory approval from the European Notified Body for its integration of Boston Scientific Corp.'s RPM Real-time Position Management technology with its EP-WorkMate workstation. This approval enables the company to sell the product within the European Community, comprising 15 countries.
Medical equipment industry
EP MedSystems, Inc. has obtained regulatory approval from the European Notified Body for its integrated electrophysiology system, which combines the company's EP-WorkMate workstation with Boston Scientific Corp.'s RPM technology. This approval allows the company to sell the product in the 15 countries of the European Community,
Medical equipment industry
Boston Scientific's TAXUS Express2 paclitaxel-eluting coronary stent system has been granted a three-month extension by the U.S. Food and Drug Administration (FDA), allowing the stent to be stored for nine months from the current six-month shelf life. This decision was made after Boston Scientific submitted data demonstrating
Medical equipment industry
Boston Scientific has announced that it has received an Investigational Device Exemption from the U.S. Food and Drug Administration (FDA) to begin its ATLAS clinical trial for the Taxus Liberte stent system, a next-generation paclitaxel-eluting coronary stent system. The trial is designed to assess the safety and efficacy of
Medical equipment industry
Stocks of several major companies declined sharply in the trading day, with shares of Genentech falling nearly 3% after the FDA issued a warning about the cancer drug Avastin. The agency cautioned that the medication can raise the risk of deadly blood clots in arteries and increase the risk of
Medical equipment industry
Boston Scientific Corporation has announced that it has received an Investigational Device Exemption from the U.S. Food and Drug Administration (FDA) to begin its ATLAS clinical trial, using the Liberte coronary stent as a platform for its paclitaxel-eluting coronary stent system. The trial aims to assess the safety and
Medical equipment industry
Boston Scientific Corp. held a meeting with the FDA to discuss the safety-related recall of its coronary stents, and the agency has decided not to take any immediate action. The company has been supplying additional information to the FDA and a second meeting is planned for next week. The FDA
Medical equipment industry
Boston Scientific Corporation (BSX) has initiated enrollment in the FLAME clinical trial, a prospective, multicenter, randomized study designed to evaluate the benefits of filter-based embolic protection during primary percutaneous coronary intervention (PCI) in acute myocardial infarction (AMI). The trial will involve approximately 500 patients at up to 60 sites in
