Boston Scientific Corporation received CE Mark approval for use of its Vercise™ Deep Brain Stimulation (DBS) System for the treatment of Parkinson’s disease. The Vercise DBS System is the first and only commercially available DBS system to incorporate multiple independent current control, which is designed to selectively stimulate targeted areas in the brain. This system is an innovative technology that is designed to provide physicians fine control of stimulation.
On Sept. 28, 2012 Boston Scientific announced that the FDA granted regulatory approval for its S-ICD® System, the world’s first and only commercially available subcutaneous implantable defibrillator (S-ICD) for the treatment of patients at risk for sudden cardiac arrest (SCA). The S-ICD System sits entirely just below the skin without the need for leads to be placed into the heart.
Yesterday Boston Scientific announced financial results for the first quarter ended March 31, 2012. Sales of Cardiac Rhythm Management devices were $501M vs. $559M for Q1 a year ago, or a decrease of 10%. Sales of Neuromodulation devices increased by 8% a year ago from $77M to $84M for Q1.
Boston Scientific announced the exercise of its option to acquire Cameron Health. Cameron Health developed the world’s first and only commercially-available subcutaneous implantable cardioverter defibrillator – the S-ICD® System that I blogged about a few weeks ago.
The agreement calls for an upfront payment of $150 million, payable upon transaction closing, an additional potential $150 million payment upon FDA approval of the S-ICD System, plus up to an additional $1.050 billion of potential payments upon achievement of specified revenue-based milestones over a six-year period following FDA approval. Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the second or third quarter of 2012.
Today Boston Scientific Corporation announced financial results for the fourth quarter and full year ended December 31, 2011. Summarizing the AIMD data:
- On a constant-currency basis, Q4 2011 CRM sales were $482M compared to $564M in Q4 2010, or down 15%
- On a constant-currency basis, 2011 CRM sales were $2,087M compared to $2,180M in Q4 2010, or down 7%
- On a constant-currency basis, Q4 2011 Neuromodulation sales were $91M compared to $86M in Q4 2010, or up 6%
- On a constant-currency basis, Q4 2011 CRM sales were $336M compared to $304M in Q4 2010, or up 10%
Click here for the news release.
Remon Medical Technologies, Ltd. was founded in 1997 in Caesarea, Israel to develop implantable, wireless pressure sensors.
Remon developed an implantable hemodynamic monitor, which allowed on-demand, non-invasive, leadless self-monitoring of pulmonary artery pressure by the patient at home. ImPressure devices were placed in the pulmonary artery, and transmitted pressure readings to a hand-held monitor. It was hoped that the system would provide early warning of the need for treatment, avoiding hospitalization and deterioration in the patient’s condition. Continue reading
InControl was founded in 1990 in Redmond, WA to develop an implantable device for treating atrial fibrillation. In November 1995, InControl announced the first human implant of its Metrix atrioverter.
The implantable atrioverter system consisted of an implantable atrial defibrillator (model 3000 or 3020) connected to right atrial (perimeter right atrial model 7205) and coronary sinus (perimeter coronary sinus model 7109) defibrillation leads and a bipolar endocardial ventricular pacing lead, a programmer, and a defibrillation systems analyzer. The device had a volume of 53cc and weighed 79 g (model 3000) or 82 g (model 3020).
The device detected AF and delivers R-wave synchronous defibrillation shocks to convert AF to sinus rhythm. It was also able to pace the ventricle after shock delivery in case of bradycardia. Shocks could be delivered at a selected voltage up to 300V. The model 3000 defibrillator had an 80µF capacitor and could deliver a maximal shock of 3J with a biphasic waveform of 3 ms/3 ms. The model 3020 defibrillator had a 160-µF capacitor with a maximal shock of 6J with a biphasic waveform of 6 ms/6 ms. Continue reading