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

Category Archives: AIMD Companies

European Heart Rhythm Association Issues Very Interesting Report on New Devices for the Treatment of Heart Failure

Posted on by Posted in BioControl, Cardiac Pacing, Cardiac Stimulation (other), CardioMEMS, CVRx, Heart Failure (CHF), Impulse Dynamics, Spinal Cord Stimulation, Vagus Nerve Stimulation

Implantable devices for the treatment of heart failure, David Prutchi, PhD

 

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).

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NanoWattICs Establishes Working Relationship with Rosellini Scientific to Develop Suite of Neurostimulation Devices

Posted on by Posted in Nanowattics, Neural Stimulation, Nexeon MedSystems, Rosellini Scientific, Ultra-Low-Power ICs

Nanowattics logo custom IC ASIC design for implantable medical devices

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

Medtronic Advisa and Revo MRI SureScan Pacemakers Delays Atrial Fibrillation Disease Progression

Posted on by Posted in Atrial Flutter/Fib, Bradycardia, Cardiac Pacing, Medtronic

Medtronic Advisa www.implantable-device.com David Prutchi PhD

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.

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Medtronic Reports CRM AIMD Sales Trend Showing Stabilization + Strong Earnings from Neuromodulation AIMDs

Posted on by Posted in AIMD Business, Bradycardia, Brain Stimulation, Medtronic, Pain, Spinal Cord Stimulation, Tachycardia

Medtronic_LogoMedtronic 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.”

NeuroPace Receives FDA PMA Approval for for the RNS System to Treat Refractory Partial Epilepsy

Posted on by Posted in Brain Stimulation, Dr. David R. Fischell, Dr. Robert Fischell, Epilepsy, NeuroPace

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.

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Interesting Article in Medical Design Briefs: Designing an ASIC Chip to Control an Implantable Glucose Measurement Device

Posted on by Posted in Diabetes, Drug Delivery, Senseonics, Sensors, Sensors for Medicine and Science, Telemetry, Ultra-Low-Power ICs

Senseonics implantable glucose sensor www.implantable-device.com David Prutchi PhDSenseonics implantable glucose sensor www.implantable-device.com David Prutchi PhD

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.

St. Jude Q3 2013 AIMD Results: CRM Down 1%, Neuromodulation 3% 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 $682 million for the third quarter of 2013, a 1 percent decrease compared to the third quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales were flat.

Of that total, ICD product sales were $418 million in the third quarter, a 1 percent increase compared to the third quarter of 2012. ICD revenue increased 2 percent after adjusting for the impact of foreign currency.

Second quarter pacemaker sales were $264 million, a 5 percent decrease compared to the third quarter of 2012. On a currency neutral basis, pacemaker revenue declined 3 percent.

Neuromodulation

St. Jude Medical sales of neuromodulation products were $104 million in the third quarter of 2013, up approximately 3 percent from the prior year on a reported and currency neutral basis.

 

Neuros Medical Receives IDE Approval to Conduct Pivotal Study

Posted on by Posted in Nerve Blocking, Neuros Medical, Pain

Neuros Medical Altius www.implantable-device.com David Prutchi PhDNeuros 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 Acquires Nanostim, Announces CE Mark of World’s First Leadless Pacemaker

Posted on by Posted in AIMD Business, Bradycardia, Cardiac Pacing, Nanostim, St. Jude Medical

cbhayden@me.com

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.

httpv://youtu.be/P6PLiyzatOo

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.

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FDA Panel Majority Votes Against Effectiveness of CardioMEMS CHAMPION HF Monitoring Device

Posted on by Posted in CardioMEMS, Heart Failure (CHF), St. Jude Medical, Telemetry

CardioMEMS miniature implantable sensor for heart failure and aneurism management

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 Raises Funds for Clinical Trials of Serenity VNS IPG for Treating Tinnitus

Posted on by Posted in Micro Transponder, Tinnitus, Vagus Nerve Stimulation

MicroTransponder Serenity IPG for treatment of Tinnitus David Prutchi PhD www.implantable-device.com

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.”

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Increase in Temperature from AIMDs Dissipating Endogenous Heat

Posted on by Posted in Impulse Dynamics, MetaCure, My Portfolio, Rechargeable Batteries, Wireless Power Transmission

Analysis of Temperature Increase at the Device/Tissue Interface for Implantable Medical Devices Dissipating Endogenous HeatActive Implantable Medical Devices generate heat as a result of resistive losses in their circuitry, exothermic reaction in their batteries, eddy-current heating due to inductive recharge, friction between mechanical components, etc.  The European Standard which regulates AIMDs limits the heating of the outer surface of an AIMD to 2ºC above normal body temperature.  Despite the rapid growth in the use of AIMDs, the relationship between AIMD endogenous heat generation and tissue temperature has not been quantified.   In the attached paper we aimed at determining the limit of endogenous heat that can be dissipated in-vivo by the surface area of an AIMD to remain compliant with the 2ºC temperature increase limit.  In our study, four Sinclair mini-pigs underwent implantation of AIMD simulants instrumented to dissipate heat and measure temperature internally, as well as the device/tissue interface temperature.

We found that for a device with the surface area and geometry that we used, approximately 1W can be dissipated before reaching the 2ºC temperature increase limit. 

Click here for a preprint of this paper

 

Interesting 2012 Presentation by Setpoint Medical on Neuromodulation for Treating Chronic Inflammatory Diseases

Posted on by Posted in Inflammation, Neural Stimulation, SetPoint Medical, Vagus Nerve Stimulation

Setpoint Medical www.implantable-device.com David Prutchi PhD

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%”

 

 

 

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.”