Implantable Devices to treat specific conditions
Neuros Medical received an Investigational Device Exemption to conduct a pivotal clinical trial to evaluate the Altius™ System High Frequency Nerve Block technology for the management of intractable limb pain of amputees. The prospective, randomized, controlled pivotal clinical trial will consist of 130 patients at 15 institutions in the U.S. to evaluate the safety and efficacy of Neuros Medical’s Altius System.
St. Jude Medical today announced the completion of its acquisition of Nanostim, Inc., a privately-owned developer of miniaturized, leadless pacemakers. The acquisition adds the world’s first and only leadless pacemaker to the St. Jude Medical product portfolio.
According to the press release:
Unlike conventional pacemakers that require a more invasive surgery, the Nanostim™ leadless pacemaker is designed to be implanted directly into the heart via a minimally invasive procedure. The device is delivered using a steerable catheter through the femoral vein, eliminating the need to surgically create a pocket for the pacemaker and insulated wires (called leads) that have historically been recognized as the most vulnerable component of pacing systems. The Nanostim leadless pacemaker recently received CE Mark approval and will be available soon in select European markets. It also recently received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and pivotal clinical trial protocol to begin evaluating Nanostim leadless technology in the U.S.
Although the FDA advisory panel found CardioMEMS’ CHAMPION HF Pressure Measurement System to be safe, on October 9, 2013, the majority of panel members decided that the implantable sensor monitor to help guide treatment in patients with congestive heart failure is not effective.
According to Forbes, one panel member said it was difficult to connect the dots between use of the monitor and decreased hospitalization and lack of data on use in women.
This is not the first time that CardioMEMS attempts to receive PMA approval. In 2011 FDA rejected the Champion implantable monitoring system for heart failure for premarket approval, in part due to questions about the validity of presented data. Last year, CardioMEMS received an FDA Warning Letter.
MicroTransponder, Inc. of Dallas, TX has raised $3.4 million to carry out clinical trials of its Vivistim System to help restore functionality in the upper limbs of stroke patients, and its Serenity System designed to “rewire” the auditory cortex of tinnitus patients. The company intends to secure a CE mark for both systems next year, and then raise more funds to support a clinical trial for a pre-market approval in the U.S.
According to the company’s website, the Serenity System™ pairs Vagus Nerve Stimulation (VNS) with listening to tones. VNS is approved by the FDA and has been used to treat over 60,000 patients for epilepsy and depression, but has not yet been evaluated for safety or efficacy to treat tinnitus. The device is fully implantable and can easily be used at home. During the therapy, an individual sits in a comfortable chair and wear headphones. They listen to tones while receiving small bursts of neurostimulation, which activate the vagus nerve. UT Dallas says that “preclinical tests demonstrated that this approach “rewires” damaged brain circuitry associated with tinnitus, potentially yielding long-term reversal of symptoms. The initial human trial in Belgium provided encouraging results.”
Surgically accessing the Vagus Nerve is not trivial, and implanting a VNS system involving cuff electrodes is risky and recovery is lengthy. Enter ElectroCore Medical of Bernards Township, New Jersey – it is developing non-invasive VNS therapies that treat or prevent symptoms of serious headache conditions, including migraines and cluster headaches, and bronchoconstriction including asthma and chronic obstructive pulmonary disorder (COPD).
Its gammaCore® therapy is applied using a hand-held, non-invasive neurostimulator device, and is used to treat primary headaches in adults, including migraine, cluster headache, and medication overuse headache. According to ElectroCore, “gammaCore relies on the activation of afferent A-fibers in the vagus nerve which is not implicated in negative cardiac or respiratory effects.” Results from studies of the therapy as both an acute and preventative against these headache types have been promising, and are ongoing around the world.
I found online the PowerPoint presentation for: R Zitnik, Y Levine, M Faltys, T Arnold, “Harnessing the Inflammatory Reflex: Using Neuromodulation as a Novel Approach to Treat Chronic Inflammatory Diseases”, North American Neuromodulation Society Meeting 2012.
The presentation shows some preliminary animal results, presents an artist’s conception of the implantable system, and concludes as follows:
“- Inflammatory diseases are a $30B market with significant unmet need
– Using neuromodulation to drive the inflammatory reflex has a sound biological foundation: Use in clinic is supported by strong preclinical evidence
– This is the first demonstration that an implantable neuromodulation device improves clinical manifestations of RA:
- Significant and clinically meaningful improvement in signs and symptoms
- Response rates were comparable to those with current biologic agents
- Further larger controlled studies in RA and other chronic inflammatory diseases are warranted.
- Our microregulator offers significant advantages over current vagal nerve stimulation devices
SetPoint intends to offer a novel therapy that will significantly increases patient QOL, while bending per-patient cost curves down by more than 60%”
Net 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:
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 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.
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 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.
Following 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.
Start-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 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:
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.