Boston Scientific’s Q2 2019 results are out, and they show very weak growth for Cardiac Rhythm Management.
According to the announcement, Q2 2019 CRM sales were $498M, compared to $494M for the same period last year, which constitutes a 0.6% increase on reported basis.
Neuromodulation grew from $202M last year to $204M, or 1.0% on reported basis.
Medtronic Micra™, Boston Scientific Empower™, and St Jude (Abbott) Nanostim™. Scale is approximate
I just came back from HRS 2019 in SF, and the implantable devices buzz this year was around leadless pacemakers and defibrillators. Most importantly, they are no longer considered a technical curiosity, but rather are entering the mainstream as a serious alternative to leaded devices.
In the bradycardia field, Medtronic showed how their MICRA™- the only commercially-available leadless pacemaker at this time – is able to pace the ventricle in sequence with the atrium through the use of a 3D accelerometer that senses the atrial contraction.
Researchers using the Boston Scientific EMPOWER™ Modular Pacing System showed how it can communicate with Boston’s EMBLEM™ S-ICD System to provide brady and ATP pacing.
On its side, Abbott is said to be working to relaunch the plagued NANOSTIM™ leadless pacemaker after early battery depletion issues caused St. Jude to issue an advisory in October 2016, followed by Abbott maintaining the worldwide halt on implantations because of problems with the device’s docking button.
More mention is also being made of EBR’s LV pacemakers as an alternative to GCV leads to deliver CRT.
EBR’s WISE wireless LV pacemaker is powered from an ultrasonic generator implanted outside the heart.
Boston Scientific announced that it has continued to improve performance in the company’s Cardiac Rhythm Management business, achieving revenue growth of 3 percent versus the prior year period on a constant currency basis from $457M to $468M.
Retrospective data for Boston Scientific’s Precision Spectra™ Spinal Cord Stimulator (SCS) System were presented at the North American Neuromodulation Society (NANS) 17th annual meeting in Las Vegas. The data show that the device provided highly significant pain relief three months after implantation.
According to the press release:
Precision Spectra is the first SCS System designed to improve pain relief using the innovative and highly advanced Illumina 3D Software, a three dimensional anatomy-driven computer model. By providing 32 contacts – twice the number of contacts available with other SCS systems – the Precision Spectra System offers more coverage of the spinal cord for the management of chronic pain.
The retrospective study of up to 213 consecutive patients at 13 centers focused on patients with chronic pain who were treated with the Precision Spectra SCS System. Results include:
A 94 percent SCS trial therapy success rate (n=213)
A highly significant reduction in pain from an average baseline score of 7.8, on a 10-point scale, to an average score of 3.2 at three months post implant (in the patients who have reached the three-month follow up, n=113)
A highly significant reduction in low back pain from an average baseline score of 7.0, on a 10-point scale, to an average of 2.9 at three months post implant (in the low back pain patients who have reached the three-month follow up, n=32)
Early results indicate improvements in function, including walking and sleeping, in addition to reductions in opioid use and disability
From today’s press release: “Improved performance in the company’s Cardiac Rhythm Management and Interventional Cardiology businesses, with CRM achieving growth of 1 percent on a constant currency basis.” Sales increased from $462M in Q3 2012 to $464M in Q3 2013, which represents a 1% change in constant-currency basis.
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.
SetPoint announced today that it has secured $27 million in financing from its current investors along with new investors Covidien Ventures, Action Potential Venture Capital Limited, the new GlaxoSmithKline (GSK) strategic venture capital fund for bioelectronic medicines and technologies, and Boston Scientific. The proceeds of the financing will be used to expand ongoing clinical development of the SetPoint bioelectronics therapy approach in rheumatoid arthritis and Crohn’s disease and advance development of the SetPoint proprietary neuromodulation platform.
Today Boston Scientific announced its Q2 2013 results. CRM sales were 3% down from $488M for Q2 2012 to $475M this year (2% on constant-currency basis).
Neuromodulation went up by a whopping 21% from last year’s Q2 $91M to $111 in Q2 2013. The press release indicated that Boston Scientific achieved global year-over-year revenue growth of 21 percent in Neuromodulation on the strength of the Precision Spectra™ Spinal Cord Stimulator (SCS) System launch.
Boston Scientific announced that it has launched a clinical trial to determine whether occipital nerve stimulation (ONS) using the Precision™ System can safely and effectively treat chronic migraine when used in conjunction with anti-migraine medications. According to the press release:
Image Credit: Boston Scientific
Boston Scientific announced today the first implantation of its Vercise™ DBS System as part of the INTREPID clinical trial. INTREPID is a prospective, multi-center, double-blinded, randomized, controlled study to evaluate the safety and effectiveness of motor function and overall quality of life in patients with the Vercise DBS System for the treatment of Parkinson’s disease. According to the press release:
Boston Scientific Corporation announced today that it generated sales of $1.761 billion and adjusted earnings per share of $0.16 for the first quarter ended March 31, 2013. These were the results for their AIMD businesses :
Boston Scientific announced today that it has acquired the fiXate™ Tissue Band and is launching it in the United States. The fiXate Tissue Band is intended to be an accessory to the leads/catheter component of Spinal Cord Stimulator/Pain Pump systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament. According to the press release:
“The fiXate Tissue Band is a novel suturing device that is designed to enable quick and simple placement of a suture to help secure a spinal cord stimulator (SCS) lead or pain pump catheter. Boston Scientific introduced the device earlier this month at the annual meeting of the American Academy of Pain Medicine in Fort Lauderdale. The product was purchased from Anulex Technologies, Inc.
Boston Scientific received FDA approval and is beginning a limited launch of the Precision Spectra Spinal Cord Stimulator (SCS) System. According to the press release:
“The Precision Spectra System is the world’s first and only SCS system with Illumina 3D™ software and 32 contacts, and is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain. Boston Scientific, the United States market leader in rechargeable SCS devices exiting 2012, is introducing the system at the annual meeting of the American Academy of Pain Medicine in Fort Lauderdale, Florida. Images of the Precision Spectra System can be downloaded here.
More than 100 million Americans suffer from chronic pain. Living in constant pain for an extended period of time can have a devastating impact on quality of life for many patients. Without relief, or the hope for relief, many patients lose the ability to sleep, work and function normally.
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.
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.