A blog about what is new (and old) in the world of active implantable medical devices

Category Archives: AIMD Companies

Cyberonics Reports 12.4% Increase in VNS Sales for Fiscal Q1 2014

Posted on by Posted in AIMD Business, Cyberonics, Epilepsy, Vagus Nerve Stimulation

Cyberonics VNS IPGs www.implantable-device.com David Prutchi PhDNet product sales increased 12.4% to $67.4 million in the first fiscal quarter ended July 26 for Cyberonics, Inc. of Houston, TX. Including license revenue, sales were up 14.2% overall, with Europe in particular contributing a strong performance. Diluted earnings per share were adjusted by $0.17 cents due to a litigation settlement.

According to the Aug. 22, 2013 press release, “operating results for the first quarter of fiscal 2014 compared to the first quarter of fiscal 2013, and other achievements, include:

  • Net product sales of $67.4 million, an increase of 12.4%;
  • Net sales of $68.9 million (including $1.5 million of license revenue), an increase of 14.2%;
  • Worldwide unit sales of 3,354, an increase of 9.8%;
  • Record U.S. net product sales of $56.4 million, an increase of 10.8%;
  • Strong International unit sales of 899, an increase of 20.8%;
  • Adjusted non-GAAP income from operations increased by 21.9% to $21.0 million and adjusted non-GAAP income per diluted share increased by 27.9% to $0.48;¹
  • Share repurchases of $13 million; and
  • Significant progress in three clinical studies, E-36, E-37, and ANTHEM.”

 

Autonomic Technologies’ Sphenopalatine Ganglion Stimulator Treats Cluster Headaches

Posted on by Posted in Autonomic Technologies, Cluster Headaches, Migraine, Sphenopalatine Ganglion Stimulation

ATI SPG Neurostimulator for Cluster Headache and Migraine www.implantable-device.com David Prutchi PhD

Autonomic Technologies, Inc. (ATI) is a medical device company located in the San Francisco Bay Area focused on the development of neurostimulators for the treatment of severe headache. The company’s initial product, the ATI Neurostimulation System, is approved in Europe for the treatment of cluster headache and is currently being investigated in a multi-center, randomized study for the treatment of high frequency, high disability migraine.

The ATI Neurostimulation System is a rechargeable, multi-channel, peripheral nerve stimulation system. The System includes:

  • The ATI Neurostimulator: A miniaturized neurostimulator (smaller than an almond) with an integral lead designed to fit ranging facial anatomy.
  • The Remote Controller: A hand-held device with simple therapy controls that provides on-demand patient-controlled SPG therapy. Therapy settings are individualized and can be adjusted quickly by physicians using a programmer laptop.

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Cleveland FES Center’s Networked Neural Prosthesis

Posted on by Posted in Brain-Computer Interface, Cleveland FES Center, Muscular Stimulation, Paralysis, Spinal Cord Injury (SCI)

Cleveland FES - Networked Neural Prosthesis (NNP) system, www.implantable-device.com, David Prutchi, Ph.D.

The Cleveland FES Center was established in 1991 as a consortium between the Cleveland VA Medical Center (CVAMC), the private educational institution of Case Western Reserve University (CWRU), and the public hospital system of MetroHealth Medical Center (MHMC).

As part of this consortium, Dr. Hunter Peckham – biomedical engineering professor at Case Western Reserve University – and his group have developed the Networked Neuroprosthetic System (NNPS), which is based on a network of small implanted modules they call “neuroprosthetic building blocks”.  These modules are distributed throughout the body, and each is dedicated to a specific function.  Modules are linked to a centralized power source via a network cable through which they also communicate with each other.

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SetPoint Medical Secures $27M to Develop VNS Device to Treat Inflammatory Diseases

Posted on by Posted in Boston Scientific, Inflammation, SetPoint Medical, Vagus Nerve Stimulation

SetPoint Medical implantable device for rheumatoid arthritis and Crohn's Disease

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.

Medtronic Implants first Activa® PC+S DBS IPG Capable of Sensing and Recording Brain Activity While Delivering Therapy

Posted on by Posted in Alzheimer's, Brain Stimulation, Medtronic, OCD, Parkinson's Disease

Activa PC+S deep brain stimulator with sensing and recording of brain activity David Prutchi PhD www.implantable-device.com

Medtronic today announced the first implant of the novel Activa® PC+S deep brain stimulation (DBS) system that, for the first time, enables the sensing and recording of select brain activity while simultaneously providing targeted DBS therapy.

According to the press release:

This initiates research on how the brain responds to the therapy and could yield insights that one day significantly change the way people with devastating neurological and psychological disorders, such as Parkinson’s disease, essential tremor, dystonia, and treatment-resistant obsessive-compulsive disorder, are treated.

The Activa® PC+S DBS system delivers proven Medtronic DBS Therapy while at the same time sensing and recording electrical activity in key areas of the brain using sensing technology and an adjustable algorithm, which enable the system to gather brain signals at various moments as selected by a physician. Initially, this new technology will be made available to a select group of physicians worldwide for use in clinical studies. These physicians will use the system to map the brain’s responses to Medtronic DBS Therapy and explore applications for the therapy across a range of neurological and psychological conditions.

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Medtronic SureScan Neurostimulators Cleared by FDA for Full-Body MRI

Posted on by Posted in Medtronic, MRI-safe, Pain, Spinal Cord Stimulation

Medtronic Restore Sensor MRI www.implantable-device.comFollowing Medtronic’s announcement in February of this year that it had 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, the Company announced today that FDA has approved the system for use in the US.  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.

The press release states:

“With the first U.S. implants of its new RestoreSensor® SureScan® MRI neurostimulation systems, Medtronic, Inc. (NYSE: MDT) is introducing the first and only implantable neurostimulation (also known as spinal cord stimulation, or SCS) systems for use in the treatment of chronic, intractable back and/or limb pain that are approved by the U.S. Food and Drug Administration (FDA) for conditionally safe* full-body Magnetic Resonance Imaging (MRI) under specific conditions.

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Sydney-based Saluda Medical Developing Closed-Loop SCS System for Pain

Posted on by Posted in Pain, Saluda Medical, Spinal Cord Stimulation

Saluda_MedicalStart-up company Saluda Medical has been awarded $5M by Australia’s New South Wales Government to support the development of a closed-loop spinal cord stimulation system for the treatment of pain.

The difference between other SCS systems and Saluda Medical’s is that the latter – the Implanted Neural Sensing & Stimulation product (INS2) – is that it both stimulates and senses nerve responses.

Saluda was spun out of NICTA – Australia’s largest publicly-funded information and communications technology research organization – earlier this year after successfully raising an initial $5M in private investment.  A new $5M grant was provided to Saluda from the inaugural round of the NSW Government’s Medical Devices Fund (MDF), a competitive technology development and commercialization program funded by the NSW Government through the NSW Ministry of Health.

 An excellent technical/business presentation video on the INS2 is available at: http://www.onemedplace.com/database/list/cid/14611/

Boston Scientific’s Q2 2013 AIMD Results: CRM Down 3%, Neuromodulation Up 21%

Posted on by Posted in AIMD Business, Boston Scientific

Boston Scientific LogoToday 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 Launches OPTIMISE Trial of Precision™ Neurostimulator for Treatment of Chronic Migraine

Posted on by Posted in Boston Scientific, Migraine, Occipital Nerve Stimulation

Precision Spectra Spinal Cord Stimulator by Boston Scientific www.implantable-device.com David Prutchi, Ph.D.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:

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WiTricity Developing Long-Range Transcutaneous Energy Transfer Solutions for AIMDs

Posted on by Posted in Rechargeable Batteries, Thoratec, WiTricity

WiTricity Logo www.implantable-device.comThis 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.”

 

 

St. Jude Q2 2013 AIMD Results: CRM Down 4%, Neuromodulation 2% Up

Posted on by Posted in AIMD Business, St. Jude Medical

logo_StJudeMedical

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.”

 

 

Algostim – Greatbatch’s Own Spinal Cord Stimulation System

Posted on by Posted in Greatbatch, Greatbatch Medical (Power), Pain, Spinal Cord Stimulation

 

Greatbatch Algostim System David Prutchi PhD www.implantable-device.comGreatbatch 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.

 

Enopace Receives Additional $5M Investment for Development of Stimulator for Treatment of Heart Failure

Posted on by Posted in Aortic Stimulation, Enopace Biomedical, Heart Failure (CHF), Sorin, Yossi Gross (Rainbow Medical)
Enopace's implantable device

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:

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Neuromodulation Startup NeuroTronik Raises $13.1M for Development of System for Treating Acute Heart Failure Syndrome

Posted on by Posted in Heart Failure (CHF), Neural Stimulation, NeuroTronik

NeuroTronik Neuromodulation www.implantable-device.comNeuroTronik, 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 Submits PMA of the Maestro VBLOC System for Treatment of Obesity

Posted on by Posted in Diabetes, EnteroMedics, Gastric Stimulation, Obesity

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.”