EndoStim announced that Argentina’s National Administration of Drugs, Food and Medical Technology (ANMAT) approved its Lower Esophageal Sphincter (LES) Stimulation System for Gastroesophageal Reflux Disease (GERD). EndoStim is currently available in Europe, Asia and several other countries in Latin America such as Chile and Colombia.
Researchers at Harvard University and the University of Illinois at Urbana-Champaign have created and tested 3D printing inks that are electrochemically active, and with which microbatteries can be fabricated.
The ink for the anode incorporates nanoparticles of one lithium metal oxide compound, while the ink for the cathode has another type of nanoparticles. A 3D printer laid the ink onto the teeth of two gold combs to create tightly interlaced stack of anodes and cathodes. The whole setup gets packaged into a tiny container and filled with an electrolyte solution to complete the battery.
Harvard engineering professor Jennifer Lewis said: “Not only did we demonstrate for the first time that we can 3D-print a battery; we demonstrated it in the most rigorous way.” Lewis is the senior author of a study on the batteries published online in the journal Advanced Materials. The researchers say their tiny batteries have electrochemical performance is comparable to commercial batteries in terms of charge and discharge rate.
Cyberonics reported $70.1 million in sales for the quarter (fiscal Q2 2014), up around 12% from than $62.9 million booked in the fiscal 2013 second quarter. Net income grew, but at a more moderate pace. It surpassed $13.8 million, versus $13.5 million in net income booked during the same period a year ago. Operating result highlights for Q2 2014 included:
As a result, Cyberonics boosted its guidance for the rest of the 2014 fiscal year. Net sales are now expected to climb to between $281 million and $285 million, versus the $279 million to $283 million stated in previous guidance.
A position paper was published yesterday by the European Heart Rhythm Association reporting on the performance of new devices for the treatment of heart failure (HF). The report has been endorsed by the Heart Failure Association.
The abstract for the paper titled “New devices in heart failure: an European Heart Rhythm Association report” reads:
Several new devices for the treatment of heart failure (HF) patients have been introduced and are increasingly used in clinical practice or are under clinical evaluation in either observational and/or randomized clinical trials. These devices include cardiac contractility modulation, spinal cord stimulation, carotid sinus nerve stimulation, cervical vagal stimulation, intracardiac atrioventricular nodal vagal stimulation, and implantable hemodynamic monitoring devices. This task force believes that an overview on these technologies is important. Special focus is given to patients with HF New York Heart Association Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex. An overview on potential device options in addition to optimal medical therapy will be helpful for all physicians treating HF patients.
The report places special focus to patients with HF New York Heart Association (NYHA) Classes III and IV and narrow QRS complex, who represent the largest group in HF compared with patients with wide QRS complex (who are candidates for treatment with cardiac resynchronization therapy – CRT).
ASIC designer NanoWattICs (Uruguay) and Rosellini Scientific (Dallas, TX) have announced they have entered into a collaborative relationship for the development of a suite of neurostimulation devices comprising implantable, wireless and non-invasive technologies. From the press release:
Rosellini Scientific, LLC (“Rosellini Scientific”; Dallas, TX, USA) and NanoWattICs SRL (“NanoWattICs”; Montevideo, UY) are pleased to formally announce their collaborative working relationship. For the past twelve months, NanoWattICs has provided support for the engineering efforts required by portfolio companies belonging to Rosellini Scientific.
Rosellini Scientific and NanoWattICs share common developmental interests and possess complementary strengths and expertise, which has produced a fruitful collaboration to date. The continuation of this long-term alliance will allow NanoWattICs to continue growing its team while participating in the development of innovative medical technologies guided by Rosellini Scientific.
“NanoWattICs are world-class engineers striving to develop the next generation of innovative medical technologies,” said Austin Duke, Director of Emerging Therapies at Rosellini Scientific. “We believe that combining their engineering expertise with the Rosellini Scientific vision will greatly enhance the process of bringing high-quality, life-changing medical technologies to the global market.”
“We are extremely pleased and excited about this collaboration opportunity with Rosellini Scientific. The combined knowledge of the two teams can hardly be matched by other players of our size in the industry,” said Pablo Aguirre, Director and Co-Founder of NanoWattICs. “We look forward to expanding our team and together bringing to market the next generation of medical devices.”
Currently, Rosellini Scientific and NanoWattICs are developing a suite of neurostimulation devices comprising implantable, wireless and non-invasive technologies. This work is being supported in part by a recently awarded grant funded by Agencia Nacional de Investigación e Innovación (ANII) in Uruguay. The devices are being developed for a variety of clinical indications, including cardiac arrhythmias, migraines and neuropathic pain.
Previously, NanoWattICs provided engineering support for Rosellini Scientific to assist in the development of a non-invasive medical imaging system (Spectral MD Inc.) and wireless telemetry capabilities for a novel glaucoma implant (collaborative development with ISTAR Medical SA).
UPDATE Jan 19, 2017: Rosellini Scientific merged with Nexeon MedSystems
Results for the MINERVA Trial were presented at the AHA Meeting, showing that Medtronic Advisa and Revo MRI(TM) SureScan(TM) pacemakers reduce the progression of permanent AF by 61%. According to the press release:
Presented as a late breaking clinical trial at the American Heart Association’s Scientific Sessions 2013, the MINERVA (MINimizE Right Ventricular pacing to prevent Atrial fibrillation and heart failure) study found that Medtronic pacemakers with atrial antitachycardia pacing (Reactive ATP(TM)), managed ventricular pacing (MVP®) and atrial intervention features were able to significantly decrease the incidence of mortality, cardiovascular hospitalizations or permanent AF at two years compared to pacemakers without these features. The effects of these features were most evident by a significant delay in the progression of atrial tachyarrhythmias to permanent AF, with a 61 percent relative risk reduction at two years.
Medtronic released today its earning reports for the second quarter of fiscal year 2014, which ended October 25, 2013.
Medtronic states in the press release: “Second quarter revenue from Implantable Cardioverter Defibrillators (ICDs) was $713 million, an increase of 4 percent on a constant currency basis in a market that continues to show a trend toward stabilization. Pacing revenue was $477 million, an increase of 2 percent on a constant currency basis.”
On related news from the release: “Neuromodulation revenue of $479 million increased 6 percent on both a constant currency and an as reported basis. Growth was driven by strong performance from Activa® deep brain stimulation systems, as well as the launch of the RestoreSensor® SureScan® MRI spinal cord stimulator in the United States.”
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.
On November 14, 2013, NeuroPace has now received FDA pre-market approval for the NeuroPace RNS System as a treatment for adults with partial onset seizures that have not been controlled with two or more antiepileptic drugs.
According to the press release:
The RNS System has been evaluated in three clinical trials, including a prospective, randomized, double-blinded, sham stimulation controlled pivotal study. The pivotal study primary effectiveness endpoint was met by demonstrating a 37.9 percent reduction in seizure frequency in patients treated with responsive stimulation compared to a 17.3 percent reduction in patients who were implanted with the device but were not receiving responsive stimulation during a three month blinded period. The difference is statistically significant (p=0.012). For those subjects who reached two years post-implant, 55% of the subjects experienced a 50% or greater reduction in seizures.
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.
A new technical information report (TIR) provides guidance to design active implantable medical device manufacturers for use in patients who may need magnetic resonance imaging (MRI) scans.
ANSI/AAMI/ISO TIR10974:2012, “Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device” was adopted and published by AAMI is meant to inform manufacturers about device behavior and patient risks so that MR-conditional AIMDs can be designed and labeled appropriately. The introduction to the TIR explains:
Test methods described in this Technical Specification are primarily designed and intended as bench-top tests using equipment and techniques to simulate the fields (B0 static, gradient, and RF) found in MR 1.5 T scanners. Although, in a few cases, clinical scanner tests are implied, in all others, the AIMD manufacturer assumes the burden for development and validation of clinical scanner-based test methods. Furthermore, the test signals and parameters specifically described within this Technical Specification for bench-top testing are not being encouraged or recommended for use on clinical scanners and to do so might result in scanner damage.
WISE (Wiringless Implantable Stretchable Electronics), a Milan- and Berlin-based medical device companyraised a seed-round of € 1 M to advance the development of its first product aimed at the spinal cord stimulation market.
WISE’s technology relies on Supersonic Cluster Beam Implantation (SCBI) for the metallization of polymers and elastomers. SCBI allows to fabricate complex microelectronic circuits and interconnects on stretchable and conformable supports that preserve their electrical performances after extensive cycles of stretching and bending of the substrates. The devices can be efficiently fabricated on biocompatible platforms, and are therefore suitable for the production of implantable biomedical devices.
The current issue of Medical Design Briefs carries an interesting article titled “Designing an ASIC Chip to Control an Implantable Glucose Measurement Device” by Uwe Guenther of ZMDI (Dresden, Germany) and Andrew DeHennis of Senseonics (formerly known as “Sensors for Medicine and Science, Inc.” in Germantown, MD).
Zentrum Mikroelektronik Dresden AG (ZMDI), Dresden, Germany, partnered with Senseonics and developed a new microchip for use in Senseionics’ fluorescence-based implantable glucose sensor. According to the article, “ZMDI’s design specifications for this application-specific integrated circuit (ASIC), which is implemented as a system- on-a-chip (SoC) for control and analysis had to meet the following main requirements: LED driver, measurement and analysis of reflected light, data pre-processing, memory, wireless interface for data transfer, no battery due to extremely low power and low voltage requirements, medical certification, and special form factor.”
Click here for the online article. Click here for a local pdf printout.
Nyxoah was founded in 2009 by Robert Taub and Dr. Adi Mashiach to develop neurostimulation treatments focused for Obstructive Sleep Apnea.
Nyxoah is currently engaged in clinical tests of a tiny, battery-less implantable neurostimulator that can electrically control the nerves of the tongue and so prevent airway blockage.
According to Nyxoah, the implantable device is 20mm high and 2.5mm wide (although it looks more like 20mm diameter x 2.5mm thick to me…). It’s designed to be implanted close to the nerves of the tongue muscle by a single small incision in a procedure that reportedly takes only 15 minutes.
The implant is powered and controlled by a disposable external adhesive patch. Every evening the OSA sufferer uses a new disposable patch that has been powered by the charger. The patch, measuring only 55 x 90 mm, is attached to the skin under the chin and has enough power to wirelessly activate the implant for a full night sleep session.
EnerSys, a global leader in stored energy solutions for industrial applications, announced that it has entered into an agreement to acquire Quallion LLC, a manufacturer of lithium ion cells and batteries for high integrity applications for $30 million. Quallion’s innovative cells – especially rechargeable Zero-Volt ™ lithium-ion batteries – are used in quite a few implantable devices.
According to the press release:
Headquartered in Sylmar, CA, Quallion’s products include lithium ion cells and batteries for diverse applications including medical devices, defense, aviation and space. The closing of the transaction is subject to customary closing conditions.
There has been some discussion in Europe over the last year to tighten the rules for medical device approvals. This discussion arose due to some scandals with breast implants in recent years. One of the things being considered was a regulatory approval process similar to the PMA process in the US. The European Parliament has just voted this down, which is great news for our industry.
They did agree on some stricter requirements for Notified Bodies, specifically the following:
These new rules will need to be approved by the EU members states so this is by no means final, but they are expected to have an impact on future AIMD development and approval.
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.