boston scientific corp (BSX) Key Developments
Boston Scientific Announces FDA Approval of New Defibrillators and Heart Failure Devices
Apr 15 14
Boston Scientific Corporation has received FDA approval for its latest generation of defibrillators and heart failure devices designed to advance patient care. The newly approved devices include the DYNAGEN(TM) MINI and INOGEN(TM) MINI ICDs, as well as the DYNAGEN(TM) X4 and INOGEN(TM) X4 CRT-Ds. The X4 line of quadripolar CRT-Ds offers 70% more pacing options to address high capture thresholds and phrenic nerve stimulation effectively, along with the larger battery capacity in the industry. These newly approved devices continue the Boston Scientific history of industry-leading projected longevity and a six-year CRT-D warranty. Extending the Boston Scientific portfolio of defibrillators, the ICDs in the MINI family are the world's smallest and thinnest devices and are designed for patient comfort. The small dimensions of the MINI ICD are up to 20% smaller by volume and up to 24% thinner than competitive devices from other manufacturers. ICDs and CRT-Ds are designed to treat patients suffering from heart failure and/or to provide protection to patients at risk of sudden cardiac death. Heart failure is a chronic, progressive condition in which the heart muscle is unable to pump enough blood to meet the body's need for blood and oxygen. Sudden cardiac death (SCD) is a sudden, unexpected death caused by loss of heart function and is a leading cause of death. Nearly 400,000 out-of-hospital cardiac arrests occur annually in the United States.
Vascular Solutions Announces Preliminary Injunction Against Boston Scientific's Guidezilla Catheter Vacated by Federal Circuit
Apr 15 14
Vascular Solutions Inc. announced that a three judge panel of the U.S. Court of Appeals for the Federal Circuit vacated the preliminary injunction that was previously issued by the District Court for the District of Minnesota effective January 13, 2014 against Boston Scientific's Guidezilla guide extension catheter. The Court's ruling on the preliminary injunction does not affect the underlying patent litigation, which is currently scheduled to be ready for trial on or after March 2015 in the District Court for the District of Minnesota.
Boston Scientific Signs Distribution Agreement with Amos Gazit
Apr 10 14
Boston Scientific BV has signed a distribution partnership agreement with Amos Gazit Ltd. in Israel. Under the new partnership, Amos Gazit Ltd. will market and distribute Boston Scientific's Interventional Cardiology - excluding the Watchman Left Atrial Appendage Occlusion device -, Peripheral Interventions, Endoscopy and Urology/Women's Health products.
Boston Scientific Corporation Begins Expansion of the S-ICD System in Asia
Apr 7 14
Boston Scientific has expanded the launch of its S-ICD System into parts of Asia. The first implant of the S-ICD System in Asia was performed in Hong Kong by Prof. Hung Fat Tse, Professor of Cardiovascular Medicine, The University of Hong Kong and Department of Medicine, Queen Mary Hospital in Pokfulam, Hong Kong, under the proctorship of Dr. Martin Stiles, Director of Electrophysiology, Waikato Hospital in Hamilton, New Zealand. This breakthrough defibrillation therapy has been commercially available in Europe since 2009 and was approved in the United States in late 2012. Boston Scientific continues to expand the availability of this unique therapy for patients and physicians around the world. The S-ICD does not have regulatory approval in China, Japan or South Korea and is not available for sale in those countries.
Boston Scientific Corporation Introduces the Expect(TM) Slimline (SL) Needle for Use During Endoscopic Ultrasound Fine Needle Aspiration Procedures
Apr 7 14
Boston Scientific Corporation has received clearance from the U.S. Food and Drug Administration (FDA) and CE Mark approval in Europe for the Expect(TM) Slimline (SL) Needle, which is now globally available for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA) procedures. The product's design incorporates extensive customer feedback and is used to collect tissue samples to diagnose and stage malignancies in organs adjacent to the gastrointestinal tract. The Expect Slimline Needle is on contract with four group purchasing organizations. Endoscopic ultrasound (EUS) is a nonsurgical, minimally invasive procedure that uses high-frequency sound waves to produce detailed images of the gastrointestinal tract and adjacent organs, including the pancreas, liver, bile duct and mediastinal space. To complement EUS, Fine Needle Aspiration (FNA) is often used to collect tissue samples for cancer diagnosis. Data have shown that EUS-FNA procedures are associated with improved survival rates for patients with pancreatic cancer due to more informed, stage-appropriate disease management.