• Aperio Technologies (Vista, California) has launched a service that it says delivers a comprehensive digital pathology solution capable of achieving a guaranteed slide throughput, i.e., the ability to digitize a pre-determined number of glass slides per hour. The Clinical Partner Service (CPS) program is designed specifically for hospitals and reference labs that need to scan batches of slides in a limited period of time on a daily basis. The CPS program enables labs to adopt digital pathology without the need for investing up-front capital.
• Boston Scientific (Natick, Massachusetts) received FDA clearance to market its WallFlex Biliary RX fully and partially covered stents for the palliative treatment of malignant bile duct strictures. All three models of the WallFlex Biliary RX Stenting System fully covered, partially covered and uncovered are now available in both the U.S. and Europe. The WallFlex Biliary RX Stent uses a platinum-cored Nitinol construction designed to deliver on three critical components: radial force, flexibility and radiopacity. The Platinol Wire provides greater flexibility – 30% more than the WallStent Endoprosthesis – to help the stent conform within tortuous anatomies. The enhanced full-length radiopacity offered by the Platinol Wire and the reconstrainable delivery system are designed to allow for more precise stent placement, while the radial force of the WallFlex Biliary RX Stent is designed to maintain patency and resist migration.
Boston Scientific also reported its exclusive sponsorship and first enrollments of the MADIT-RIT clinical trial. MADIT-RIT is designed to determine which device programming strategy best minimizes the occurrence of unnecessary therapy in patients who have received an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) and have no history of cardiac arrest. Unnecessary therapy has a significant impact on quality of life, especially for patients with no history of cardiac arrest.
• HeartWare International (Framingham, Massachusetts) has received FDA approval to expand the number of clinical sites participating in its U.S. bridge-to-transplant trial, known as the ADVANCE trial. HeartWare will be permitted to enroll a total of 40 clinical sites for the purposes of evaluating the Company's Ventricular Assist System (HVAD) in end-stage heart failure patients requiring circulatory support to bridge them to a heart transplant. The HeartWare Ventricular Assist System features the HVAD pump, a small full-output circulatory support device (up to 10L/min flow) designed to be implanted next to the heart, avoiding the abdominal surgery generally required to implant competing devices.
• Pico-Tesla (Littleton, Colorado) said that it has commenced a Phase III clinical trial of its Resonator system that facilitates the company's magnetic (Magneceutical) therapy for treating Parkinson's disease patients. The purpose of the clinical trial is to demonstrate the efficacy of Magneceutical Therapy as an adjunctive therapy to improving aspects of health and quality of life that are relevant to patients with Parkinson's Disease. Magneceutical Therapy involves the use of an extremely low-level electromagnetic field (EMF) applied by a specially designed device-the Resonator, along with proprietary therapeutic protocols-intended to improve a number of the signs and symptoms of Parkinson's and other neurological-based diseases.