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

Category Archives: AIMD Companies

NeuroVista Publishes Study Results for their Implantable Seizure-Warning Device

Posted on by Posted in EEG Monitoring, Epilepsy, NeuroVista

 

NeuroVista implantable device for seizure detection www.implantable-device.com David Prutchi PhD

Seattle-based NeuroVista was founded in 2002 by Dr. Daniel DiLorenzo to develop an implantable device for the early detection of epileptic seizures.  The NeuroVista seizure advisory system is based on an implantable device that senses EEG irregularities that precede a seizure. Early warning allows patients to take medicine and find a safe place to lie down. Although some epilepsy sufferers can feel seizures coming, many cannot.

In NeuroVista’s Seizure Advisory System (SAS), intracranial EEG signals are recorded through electrodes implanted between the skull and the brain surface. Data storage and signal telemetry takes place within the pectorally-implanted can that transmits signals wirelessly to an external handheld device that processes the data and transmits visual and audible signals to the patient. The external pager-like receiver displays a blue light when there is a low likelihood of seizures, white indicates medium susceptibility, and red alerts to a high likelihood of impending seizure.

Results of the system on 11 patients were published in the Lancet an a paper entitled “Prediction of seizure likelihood with a long-term, implanted seizure advisory system in patients with drug-resistant epilepsy: a first-in-man study.”  From the paper:

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St. Jude Launches Allure Quadra™ CRT-P IPG with Quadripolar Lead Technology

Posted on by Posted in Bradycardia, Cardiac Pacing, Heart Failure (CHF), St. Jude Medical

St. Jude Launches Allure Quadra™ CRT-P IPG with Quadripolar Lead TechnologySt. Jude Medical today announced CE Mark approval and European launch of its Allure Quadra™ Cardiac Resynchronization Therapy Pacemaker (CRT-P), which brings the quadripolar lead technology to the pacemaker market for the first time.  According to the press release:

“Quadripolar leads allow for increased implant efficiencies, which clinical data indicates can result in fewer surgical revisions. The Allure family of devices also offer enhanced heart failure (HF) diagnostics, including CorVue™ Impedance Monitoring, for improved patient management.

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Boston Scientific’s Q1 3013 AIMD Results: CRM Down 4%, Neuromodulation Up 6%

Posted on by Posted in AIMD Business, Boston Scientific

Boston Scientific Logo

Boston Scientific Corporation announced today that it generated sales of $1.761 billion and adjusted earnings per share of $0.16 for the first quarter ended March 31, 2013.  These were the results for their AIMD businesses :

  • Cardiac Rhythm Management declined 5% (4% using constant-currency basis) to $478M in Q1 2013 compared to $501M in Q1 2012.
  • Neuromodulation was up 6% to $89M in Q1 2013 vs. $84M in Q1 2012.

 

 

 

 

Impulse Dynamics Launches CE-Marked OPTIMIZER IVs System for the Treatment of Heart Failure

Posted on by Posted in Cardiac Stimulation (other), Dr. Shlomo Ben-Haim (Medinvest), Heart Failure (CHF), Impulse Dynamics, My Portfolio

Impulse Dynamics OPTIMIZER IVs IPG for treatment of heart failure

Impulse Dynamics (yes, the company for which I work) launched its new, CE-marked OPTIMIZER™ IVs implantable device for the treatment of heart failure at the 79th Annual Meeting of the German Cardiac Society (Mannheim, Germany, 3–6 April 2013).

The OPTIMIZER™ IVs Implantable Pulse Generator (IPG) is a programmable telemetric device intended to treat moderate to severe heart failure resulting from left ventricular dysfunction by monitoring intrinsic cardiac electrical activity and delivering Cardiac Contractility Modulation (CCM) signals during the ventricular absolute refractory period.  These electrical signals are intended to influence myocardial properties in patients, thereby reducing their symptoms and improving quality of life and exercise tolerance.

The OPTIMIZER™ IVs IPG was designed to deliver CCM signals during the ventricular absolute refractory period in synchrony with locally-sensed electrical activity. The microprocessor controlled implantable device comprises intracardiac electrogram sensing circuits, control logic, communications circuitry, and circuitry to generate the CCM signals.  Electrogram signals are detected from and CCM signals are delivered to the heart using standard chronically-implantable bipolar pacing leads.  The implant procedure is similar to implantation procedures for other cardiac rhythm management devices.

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St. Jude’s Q1 2013 AIMD Results: CRM Down 7%, Neuromodulation Down 4%

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

logo_StJudeMedical

St. Jude Medical announced sales results for Q1 2013.  AIMD results from their press release:

“Cardiac Rhythm Management (CRM)

Total CRM sales, which include implantable cardioverter defibrillator (ICD) and pacemaker products, were $678 million for the first quarter of 2013, an 8 percent decrease compared to the first quarter of 2012. After adjusting for the impact of foreign currency, total CRM sales decreased 7 percent.

Of that total, ICD product sales were $427 million in the first quarter, a 5 percent decrease compared to the first quarter of 2012. ICD revenue decreased 4 percent after adjusting for the impact of foreign currency.

First quarter pacemaker sales were $251 million, a 12 percent decrease compared to the first quarter of 2012.”

…

“Neuromodulation

St. Jude Medical sales of neuromodulation products were $99 million in the first quarter of 2013, down 4 percent from the prior year.”

 

 

Boston Scientific Acquires and Launches Fixate Tissue Band for Spinal Cord Stimulator Leads and Pain Pump Catheters

Posted on by Posted in Boston Scientific, Drug Delivery, Pain, Spinal Cord Stimulation

Fixate Tissue Band for Spinal Cord Stimulator Leads and Pain Pump Catheters David Prutchi PhD www.implantable-device.com

Boston Scientific announced today that it has acquired the fiXate™ Tissue Band and is launching it in the United States.   The fiXate Tissue Band is intended to be an accessory to the leads/catheter component of Spinal Cord Stimulator/Pain Pump systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.  According to the press release:

“The fiXate Tissue Band is a novel suturing device that is designed to enable quick and simple placement of a suture to help secure a spinal cord stimulator (SCS) lead or pain pump catheter. Boston Scientific introduced the device earlier this month at the annual meeting of the American Academy of Pain Medicine in Fort Lauderdale. The product was purchased from Anulex Technologies, Inc.

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Boston Scientific’s Precision Spectra™ 32-Contact SCS Launched in the US

Posted on by Posted in Boston Scientific, Pain, Spinal Cord Stimulation

Precision Spectra SCS David Prutchi PhD www.implantable-device.comBoston Scientific received FDA approval and is beginning a limited launch of the Precision Spectra Spinal Cord Stimulator (SCS) System.  According to the press release:

“The Precision Spectra System is the world’s first and only SCS system with Illumina 3D™ software and 32 contacts, and is designed to provide improved pain relief to a wide range of patients who suffer from chronic pain. Boston Scientific, the United States market leader in rechargeable SCS devices exiting 2012, is introducing the system at the annual meeting of the American Academy of Pain Medicine in Fort Lauderdale, Florida. Images of the Precision Spectra System can be downloaded here.

More than 100 million Americans suffer from chronic pain. Living in constant pain for an extended period of time can have a devastating impact on quality of life for many patients. Without relief, or the hope for relief, many patients lose the ability to sleep, work and function normally.

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Medtronic’s Fully Implantable Percutaneous Nerve Stimulation (PNS) System for Treatment of Lower Back Pain

Posted on by Posted in Medtronic, Pain, PNS, Spinal Cord Stimulation

Medtronic Activa PC used by Functional Neurostimulation for treating Alzheimer'sIn May 2011 Medtronic received the CE Mark for the first 16-electrode, fully implantable system for the percutaneous delivery of peripheral nerve stimulation (PNS) in the management of chronic back pain.

PNS involves an implant of electrical leads just under the skin of the lower back.  These leads are connected to a stimulator which delivers mild electrical impulses to the nerves, interrupting pain signals traveling through the nervous system to the brain.

Medtronic today announced the first patient enrollments in the SubQStim II pivotal clinical trial to pursue FDA approval PNS (also known as subcutaneous nerve stimulation or SQS), for the reduction of chronic, intractable post-surgical back pain.

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St. Jude’s DBS Systems First to Receive CE Mark for Both Primary and Secondary Dystonia

Posted on by Posted in Brain Stimulation, Dystonia, Parkinson's Disease, St. Jude Medical

St Jude Medical implantable devices for dystonia David Prutchi PhD www.implantable-device.com

St. Jude Medical announced CE Mark approval of its Brio™, Libra™ and LibraXP™ deep brain stimulation (DBS) systems for managing the symptoms of intractable primary and secondary dystonia, a neurological movement disorder that causes a person’s muscles to contract and involuntarily spasm, reducing the ability to control movement. This approval represents the first by a regulatory agency for the use of deep brain stimulation to manage both primary and secondary dystonia.

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Vibrant’s Vibrating Capsule for Treating Constipation

Posted on by Posted in Constipation, Vibrant Ltd.

Vibrant Capsule for tretment of constipation www.implantable-device.com

I know that it’s April 1st, but this post is not an April Fool’s joke.  Israeli company Vibrant Ltd. has developed a vibrating capsule that the Company claims to provide chemical-free and safe treatment for patients suffering from constipation.  According to Vibrant:

“The capsules, mechanically operated, aid in treating constipated patients without side effects.

Constipation relief is achieved by the capsule’s vibrations on the large intestinal wall, consequently inducing natural peristaltic activity, generating spontaneous additional bowel movement.

Vibrant capsule is easy to swallow. The capsule is controlled through algorithms, predefined by Vibrant’s R&D and gastroenterologist.

The capsule is activated by a base unit that transfers the data of the predefined algorithm into the capsule, before swallowing it.

The capsule operates inside the large intestine and is washed out of the body with the bowel movement.”

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Sorin Receives Conditional FDA IDE Approval to Study its Paradym CRT-D IPG and SonRtip Hemodynamic Sensor Lead

Posted on by Posted in Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), Sorin, Tachycardia

Sorin Paradym CRT-D David Prutchi PhD www.implantable-device.comSorin announced it received U.S. Food and Drug Administration (FDA) conditional approval for its Investigational Device Exemption (IDE) application and clinical trial protocol for RESPOND CRT. The trial will study the safety and effectiveness of the innovative SonR cardiac resynchronization therapy (CRT) optimization system in patients with advanced heart failure. RESPOND CRT is a multi-center, randomized, two-arm, double-blinded, prospective trial that will enroll more than 1,000 patients in the United States and other geographies.

The SonR optimization system is comprised of the SonR hemodynamic sensor embedded in the SonRtip atrial pacing lead and the PARADYM RF SonR CRT-D device, which includes a unique algorithm to automatically optimize the patient’s atrioventricular (AV) delay and interventricular (VV) delay timing. While there are several CRT systems on the market, studies have shown that approximately one-third of patients with advanced heart failure do not effectively respond to CRT. The SonR system is the first and only CRT hemodynamic sensor based system designed to automatically adjust on a weekly basis. The timing of electrical impulses delivered to the heart is based on the patient’s heart activity and need – with the goal of improving the patient’s response to CRT. Typically this device re-programming is done manually in the clinic using echocardiography.

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Biotronik’s Iforia DF4 ICD/CRT-D CE-Approved as Compatible with MRI

Posted on by Posted in Biotronik, Cardiac Pacing, Cardioversion/Defibrillation, Heart Failure (CHF), MRI-safe, Tachycardia

Iforia MRI-compatible ICD/CRT CRT-D David Prutchi PhD www.implantable-device.comBiotronik announced that it had received CE-approval for the world’s first DF4 ICD/CRT-D series approved for MRI. In addition, this series contains one of the world’s smallest ICDs– the Iforia single chamber ICD.

Aside from featuring ProMRI®technology, which allows patients to undergo potentially life saving MRI scans, Iforia also includes the industry standard DF4 connector system, which is designed to simplify and shorten the implantation procedure. The DF4 connector combines the traditional three connectors into one, allowing for a more convenient implantation procedure without compromising safety.

Click here for the press release.

CircuLite Receives Approval to Start IDE Trial of its SYNERGY Circulatory Support System

Posted on by Posted in Circulatory Support, CircuLite, Heart Failure (CHF)

CircuLite Vascular Support Pump www.implantable-device.com David Prutchi PhDThe SYNERGY Circulatory Support System is a micro-blood pump that provides up to 4.25 liters of blood per minute and reduces the heart’s workload, while improving blood flow to vital organs. The system is surgically implanted using a mini-thoracotomy and the micro-pump is placed in a pacemaker-like pocket. The system’s less invasive procedure is intended to reduce the surgical risks associated with cardiopulmonary bypass support. In addition, SYNERGY is intended to reduce rehospitalizations associated with heart failure symptoms. SYNERGY is designed and manufactured in Aachen, Germany.

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Retina Implant AG Publishes Study Results on its Alpha IMS Implant

Posted on by Posted in Blindness, Retina Implant AG, Retinal Stimulation, retinitis pigmentosa

Retina Implant AG www.implantable-device.com David Prutchi PhD

Retina Implant AG published study results on its Alpha IMS Implant for functional vision restoration.  According to the press release, “Retina Implant AG, the leading developer of subretinal implants for patients blinded by retinitis pigmentosa (RP), announced results from part of its multicentre study were published today in the peer-reviewed journal Proceedings of the Royal Society B. The research found that, during the course of a three to nine month observation period, functional vision was restored in the majority of nine German patients implanted with a subretinal microchip as part of the first module of the Company’s second human clinical trial. In addition, visual acuity for two of the nine patients surpassed the visual resolution of patients from the Company’s first human clinical trial.

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Second Sight Receives FDA Clearance for Argus II Retinal Prosthesis

Posted on by Posted in Alfred E. Mann, Blindness, Retinal Stimulation, retinitis pigmentosa, Second Sight

Second Sight Argus II Retinal Prosthesis www.implantable-device.com David Prutchi PhD

On February 4, 2013, after more than 20 years of research and development, Second Sight Medical Products, Inc., announced that its Argus® II Retinal Prosthesis System (“Argus II”) has received U.S. market approval from the Food and Drug Administration (FDA) to treat individuals with late stage retinitis pigmentosa (RP). This announcement follows receipt of the European approval in 2011, and a unanimous recommendation by the FDA’s Ophthalmic Devices Advisory Panel in September 2012 that this revolutionary product be made available to treat this patient population in the U.S.

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