Boston Scientific reported Q4 2012 CRM sales of $457M versus $482M for Q4 2011, or a decline of 5% (4% on constant-currency basis). For the same period, neuromodulation sales grew by 14% from $91M to $104M.
Worldwide CRM sales for the full 2012 year were $1,908M compared to $2,087M for 2011, or a decline of 9% (7% on constant-currency basis). Neuromodulation sales grew by 9% for 2012 to $367M from $336 in 2011.
Medtronic has introduced in Europe the first and only implantable neurostimulation systems indicated for use in the treatment of chronic back and/or leg pain that are designed for full-body Magnetic Resonance Imaging (MRI) scans under specific conditions. Medtronic SureScan neurostimulation systems include enhancements to existing devices as well as specially designed leads to reduce or eliminate the hazards produced by the MRI environment. The devices also include a proprietary SureScan programming feature, which sets the device into an appropriate mode for the MRI environment.
St. Jude Medical today reported sales and net earnings for the fourth quarter and year ended December 29, 2012. According to the announcement:
“Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $682 million for the fourth quarter of 2012, a 6 percent decrease compared to the fourth quarter of 2011. After adjusting for the impact of foreign currency, total CRM sales decreased 5 percent. Total CRM product sales for the full-year 2012 were $2.854 billion, down approximately 6 percent from 2011. On a currency neutral basis, total CRM sales declined 3.5 percent from the prior year.
SetPoint Medical, headquartered in Valencia, California, is developing neuromodulation therapies for patients with inflammatory autoimmune diseases, such as rheumatoid arthritis (RA), inflammatory bowel disease (IBD), psoriasis, diabetes, heart disease, and multiple sclerosis. SetPoint’s proprietary neuromodulation platform consists of an implantable “microregulator”, wireless charger and iPad prescription pad application.
Toronto-based Functional Neuromodulation announced that it implanted the first U.S. Alzheimer’s patient in the “ADvance Study” with a deep brain stimulation (DBS) system meant to improve cognitive performance. ADvance will evaluate the safety and potential clinical benefit of DBS of the fornix (DBS-f), a major inflow and output pathway in the brain’s memory circuit, for patients with mild Alzheimer’s. The ADvance Study is being conducted using Medtronic Activa DBS IPGs.
While DBS has been an effective treatment for movement disorders for more than 15 years, it was only recently that this approach was first applied to Alzheimer’s. Dr. Andres Lozano, a neurosurgeon at University of Toronto and Scientific Founder of Functional Neuromodulation, originated the concept of treating memory disorders using deep brain stimulation (DBS) while treating a patient suffering from morbid obesity. In this patient, DBS stimulation of the hypothalamus and fornix was associated with an unexpected observed improvement in the patient’s memory.
Boston Scientific Received European Regulatory Approval For New Precision Spectra™ Spinal Cord Stimulator System. It is the first and so-far only SCS system with 32 contacts and 32 dedicated power sources designed to provide pain relief to a broad spectrum of chronic pain patients.
Image Credit: Boston Scientific
Boston Scientific has received CE Mark approval for increased longevity projections for the INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The longevity projections are based on data submitted to the European authorities and vary for each device dependent on the model type and settings.
Projected device longevity exceeds 10 years for some models, approaches eight years for its CRT-D devices, and according to the press release is up to double that of comparable competitive device models. The company supports these devices with warranties of up to 10 years:
Warranties: INCEPTA and ENERGEN VR ICD: 10 years; INCEPTA and ENERGEN DR ICD: eight years; PUNCTUA and TELIGEN ICD: seven years; INCEPTA and ENERGEN CRT-D: six years; and PUNCTUA & COGNIS CRT-D: five years.
Today Boston Scientific reported its results for Q3 2012. For its AIMD divisions:
Cardiac Rhythm Management sales dropped from $503M in Q3 of 2011 to $462M for this year (-8%), a 6% decrease on constant-currency basis.
Neuromodulation sales grew by 5% from $84M to $88M.
Biotronik announced the European market release of BioMonitor®, an implantable cardiac device designed for the highly accurate and reliable monitoring and management of patients with atrial fibrillation (AF) or unexplained syncope.
According to Biotronik’s press release:
“BioMonitor® is a subcutaneous implantable leadless cardiac monitor for the long-term continuous remote monitoring of patients with arrhythmias such as AF, bradycardia, sudden rate drop, asystole and tachycardia.
As sensitivity and specificity are essential in the detection of arrhythmias such as AF, BIOTRONIK has developed ClearSense Technology with a unique three-vector signal detection that produces highly precise and reliable arrhythmia monitoring.
St. Jude announced today its third quarter 2012 results. From the press release:
“Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $691 million for the third quarter of 2012, an 8 percent decrease compared with the third quarter of 2011. Total CRM sales for the third quarter decreased 4 percent after adjusting for the impact of foreign currency.
Of that total, ICD product sales were $412 million in the third quarter, a 7 percent decrease compared with the third quarter of 2011. On a constant currency basis, total ICD sales declined 4 percent from the prior year.
Third quarter pacemaker sales were $279 million, a 9 percent decrease compared to the third quarter of 2011. After adjusting for the impact of foreign currency, pacemaker sales decreased 4 percent.”
…
“St. Jude Medical sales of neuromodulation products were $101 million in the third quarter of 2012, down 1 percent from the comparable quarter of 2011. Revenue for the third quarter increased 2 percent after adjusting for the impact of foreign currency”
Image Credit: Boston Scientific
Boston Scientific has received regulatory approval to market the RELIANCE® 4-FRONT™ lead, its next generation implantable defibrillation lead now available in Europe and Asia. According to the press release, “The RELIANCE 4-FRONT lead is built upon the demonstrated performance and reliability of the RELIANCE lead platform with design enhancements intended to simplify the implant procedure. With more than 350,000 implants worldwide, RELIANCE leads have demonstrated a 98.9 percent survival probability at 8 years.
“Leveraging the RELIANCE platform, we made a series of targeted design enhancements with RELIANCE 4-FRONT to improve and simplify implantation,” said Kenneth Stein, M.D., chief medical officer of Boston Scientific’s Cardiac Rhythm Management Group. “RELIANCE 4-FRONT represents our continued dedication to product innovation to meet the needs of patients and physicians.”
Image Credit: Boston Scientific
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.
Bionic Vision Australia researchers announced on August 30, 2012 that they successfully performed the first implantation of an early prototype bionic eye with 24 electrodes.
According to the press release:
My friend Daniel Villamil from CCC Medical in Uruguay sent me these pictures of a very unique device in his colection. It is a late-1960s/early 1970s pacemaker made in Sao Paulo, Brasil.
UPDATE Oct 3, 2012:
CCC’s CEO Julio Arzuaga recalled that this pacemaker was manufactured in the early 1960s by the Instituto de Cardiologia Dante Pazzanese in Sao Paulo, Brasil. The physicians leading the pacemaker team were Dr. Decio Kormann and Dr. Adib Jatene.
Dr. Orestes Fiandra used to implant these Brasilian pacemakers in Uruguay. However, they were not very reliable. For this reason, and with help from Drs. Kormann and Jatene, Dr. Fiandra started CCC del Uruguay as a more industrial environment for the production of pacemakers.
St. Jude Medical announced it has received European CE Mark approval of its Eon™ family of neurostimulators for treating patients with intractable chronic migraine.
According to the press release:
“Intractable chronic migraine is one of the most difficult-to-treat headache disorders,” said Professor Gennaro Bussone, M.D., head of the Neurological Department at Istituto Besta in Milan Italy. “By definition, people living with this condition are spending half their month living with debilitating headaches. This therapy expands our options in helping manage patients who suffer with disabling chronic migraine symptoms.”