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:
This month’s Medical Device and Diagnostic Industry (MD+DI) magazine carried an interesting article by David Schatz – WiTricity’s VP Sales – on their efforts to develop highly resonant wireless power transfer technology for use in AIMDs. The article is available online at http://www.mddionline.com/article/wireless-power-medical-devices.
The article mentions the work that WiTricity has been doing with Thoratec to wirelessly power a HeartMate II® LVAD, and which was announced back in May 2011. David told me that for this project, WiTricity has been able to transfer 20 Watts over 20 cm, with SAR and temperature-rise compliance, and without the use of resonant repeaters.
If these levels scale well to small receiver units, I believe that this technology would enable not only the development of deep-implant AIMDs that are currently outside the range of classical resonant-inductive TET, but would also allow the development of more patient-friendly rechargeable AIMDs that don’t require dedicated recharge sessions, but rather receive their charge from a WiTricity transmitter under the patient’s bed while the patient sleeps. From the MD+DI article:
“A circulatory assist device like an LVAD is just one example of a medical device that can harness the benefits of highly resonant wireless power transfer. There is also promise for other implanted devices, including neurostimulators, implantable defibrillators and pacemakers, implantable drug-delivery pumps, electronic ophthalmic and cochlear implants, and rechargeable hearing aids.
In this broad range of implanted medical devices, high-resonance wireless power transfer can enable higher charge rates than would be possible with traditional magnetic induction. Higher charge rates allow for device implantation deeper within the body and enable more flexible charger configurations outside of the body.
For example, the wireless charger for ophthalmic or cochlear implants could be deployed in a pair of eyeglasses or a pillow. The wireless charger for a neurostimulator implanted in the lower back could be deployed in a chair or bed. Hearing aids could be recharged by simply placing them in a charging box on one’s nightstand, without requiring precise fixturing or galvanic contacts as do today’s rechargeable hearing aids.”
From today’s press release:
“Cardiac Rhythm Management (CRM)
Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $718 million for the second quarter of 2013, a 4 percent decrease compared to the second quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales decreased 2 percent.
Of that total, ICD product sales were $454 million in the second quarter, a 1 percent decrease compared to the second quarter of 2012. ICD revenue was flat after adjusting for the impact of foreign currency.
Second quarter pacemaker sales were $264 million, an 8 percent decrease compared to the second quarter of 2012. On a currency neutral basis, pacemaker revenue declined 6 percent.”
…
“Neuromodulation
St. Jude Medical sales of neuromodulation products were $108 million in the second quarter of 2013, up approximately 2 percent from the prior year.”
Greatbatch Medical, which moved its headquarters to the Dallas, TX area last year, announced that it has set a target of at least 5%/yr organic growth. To accomplish this growth, the Company recently announced consolidating operations of its various divisions in order to create efficiency.
In addition however, Greatbatch is diversifying from being strictly a developer of implantable-grade components into a firm capable of developing complete medical devices. Greatbatch’s CEO Thomas Hook announced in March 2013 that Greatbatch is internally developing its own spinal cord stimulation system. The device, called Algostim, is nearing completion of development and will be moving into the commercialization phase. The company is looking for a partner to take the Algostim device into the $1.4 billion spinal cord stimulation market, which has been growing at more than 10%/yr.
Click here for an extract describing Algostim from Greatbatch’s investor day of March 2013.
From Patent Application Publication: US 2011/0137370 A1
Sorin recently announced a $5 million investment in Israeli startup Enopace Biomedical, which is developing an endovascular neurostimulation system for heart failure. Back in October 2011 Sorin invested $7 million to finance the initial clinical studies of Enopace’s technology as well as ongoing product development.
Very scant details are available besides that it is developing a neuromodulation system to treat patients with congestive heart failure. According to the company, its technology consists of a minimally invasive, implantable neurostimulation device that increases cardiac efficiency by reducing left ventricular workload.
From Enopace’s patent applications, it seems that Enopace’s device consists of a stimulation unit that is placed within the aorta close to the heart, and which is driven wirelessly from a coil that is placed within a vein closeby to the artery. The transmitting coil is in turn driven from an implanted control unit that is implanted subcutaneously.
Israeli business news website “Globes” interviewed Enopace’s CEO Amir Dagan, and reported in February 2013:
NeuroTronik, a recent spin-off from Synecor, a Chapel Hill business accelerator, announced that it has raised $13.1M for the development of a neuromodulation system intended for the treatment of acute heart failure syndrome.
Douglas Reed, a partner in the VC group backing NeuroTronik said that the device aims to shorten hospital stays and reduce the need of patients to return to the hospital a few weeks later. According to Reed:
“It’s a way of stimulating the heart to increase the pumping effectiveness, the effectiveness of the contractions, so it improves cardiac function while the device is in place.”
EnteroMedics reported that it has submitted its pre-market approval application for FDA review of its Maestro Rechargeable System’s VBLOC vagal blocking therapy as a treatment for obesity
This is an important step for an implantable device company that faced very tough times in 2009 after its US clinical trial failed to meet a critical effectiveness goal. EnteroMedics conducted a pivotal trial, and believes that the data are positive, leading it to submit the PMA application.
According to the press release, EnteroMedics president & CEO Mark Knudson said that “the Maestro System is a unique, neuroscience-based approach to the treatment of this epidemic disease, one which offers the potential to fill a significant gap in the obesity treatment spectrum. In the hundreds of patients treated to date, in addition to showing clinically meaningful weight loss, VBLOC Therapy has demonstrated an excellent benefit-to-risk profile; a criterion identified by the Agency as central to the review and approvability of new obesity treatment devices.”
Image Credit: NeuroPace
NeuroPace is a privately-held company in Mountain View, CA. Their RNS® implantable stimulator, along with depth leads and cortical strip leads are designed for the treatment of medically refractory partial epilepsy.
Unlike Cyberonics’ VNS IPGs, the RNS neurostimulator is designed to detect abnormal electrical activity in the brain and respond by delivering electrical stimulation to normalize brain activity before the patient experiences seizure symptoms. The neurostimulator is implanted in the cranium and connected to one or two leads that are implanted near the patient’s seizure focus.
NeuroPace recently disclosed that it has raised about $18 million of a planned $50 million in new funding. NeuroPace has raised about $180 million since it was founded in 1997.
AIGISRx® is an Antibacterial Envelope that is made from knitted polypropylene mesh substrate, coated with a polyarylate bioresorbable polymer containing two antimicrobial antibiotics, minocycline and rifampin. AIGISRx is a dual component (resorbable and non-resorbable), sterile prosthesis designed to reduce infection and to stabilize the implantable pacemaker or defibrillator when implanted in the body.
Miniature, ultra-flexible electrode (credit: EPFL)
Aleva Neurotherapeutics is a spinoff of the Swiss Federal Institute of Technology (EPFL) Microsystems Laboratory. Aleva is developing unique microfabricated devices to more specifically target deep-brain stimulation.
kurtzweilai.net recently published an interesting blog about the technology. From the post:
“Miniature, ultra-flexible electrodes could be the answer to more successful treatment for Parkinson’s diseases, according to Professor Philippe Renaud of the École Polytechnique Fédérale de Lausanne (EPFL) in Switzerland.
He has developed soft arrays of miniature electrodes in his Microsystems Laboratory that open new possibilities for more accurate and local deep brain stimulation (DBS).
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Mainstay Medical was founded in 2008 by entrepreneur Dr. Danny Sachs. The company’s ReActiv8 neurostimulator is intended to treat chronic low back pain caused by arthrogenic muscle inhibition. This is a neuroprotective condition in which the brain reflexively attempts to limit motor stimulation and movement in muscles surrounding a joint in response to damage or injury to the joint. In patients with this type of back pain, an initial injury triggers this reflexive inhibition, and the brain tries to limit painful movement by altering nerve transmissions to the deep stabilizing muscles of the spine, causing a loss of motor control, an unstable spine, and greater susceptibility to reinjury.
Neuros Medical, a Cleveland, Ohio based neuromodulation company, developed the Altius implantable system to deliver Electrical Nerve Block therapy for the treatment of chronic pain in a variety of applications including neuroma/residual limb pain, chronic post surgical pain, and chronic migraine.
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Medtronic’s press release:
MINNEAPOLIS – June 26, 2013 – In June 2013, Medtronic, Inc. (NYSE: MDT) initiated four medical device notifications to customers worldwide about the SynchroMed® Implantable Infusion System. These notifications provide clinicians with information to help identify and manage issues that impact the safe and reliable delivery of therapy using the SynchroMed Implantable Infusion System.
The United States Food and Drug Administration (FDA) has classified three of these notifications as Class I recalls.The fourth notification is an update to a 2011 action related to pump refill which was previously classified by the FDA as a Class I recall.
Patients are encouraged to maintain regular follow-up appointments with their physicians; however, if they experience a change or return of symptoms or hear a device alarm, they should contact their physician immediately. No action is required of physicians beyond the recommendations provided in the notifications.
Medtronic’s intrathecal drug delivery systems are used to treat chronic, intractable pain and severe spasticity of cerebral or spinal origin. These notifications do not involve Medtronic external insulin pumps for diabetes.
Specifically, the Neuromodulation business of Medtronic has initiated the following field corrective actions:
St. Jude Medical today announced CE Mark approval of its next-generation quadripolar device, the Quadra Assura MP™ cardiac resynchronization therapy defibrillator (CRT-D). The device features MultiPoint™ Pacing (MPP) technology that enables physicians to pace multiple locations on the left side of the heart. This gives the clinician more choices to best optimize cardiac resynchronization therapy (CRT) pacing to meet individual patient needs.
According to the press release:
The Quadra Assura MP CRT-D is designed to work with the Quartet™ Lead, which has four electrodes to offer maximum flexibility for different pacing configurations. The new MPP capability allows physicians to program simultaneous or sequential delivery of two left ventricular (LV) pulses per pacing cycle, rather than the standard single pacing pulse. The capability to deliver two LV pulses per cycle allows physicians to tailor CRT pacing for each patient, potentially leading to more effective outcomes compared to single site pacing, which may be particularly beneficial in patients not responding to traditional bi-ventricular pacing therapy.