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

Impulse Dynamics Announced First Implant for Integra CCM-D™ Clinical Trial in May 2023

Posted on by Posted in Cardiac Contractility Modulation, Cardiac Pacing, Cardiac Stimulation (other), Cardioversion/Defibrillation, David Prutchi's Portfolio, Heart Failure (CHF), Impulse Dynamics, My Portfolio, Tachycardia
Impulse Dynamics OPTIMIZER Integra CCM-D IPG

Image credit: Impulse Dynamics

Impulse Dynamics, the company where I am the CTO and Executive VP of Product Development, announced on May 18, 2023 the completion of the first implantation for the INTEGRA-D clinical trial, designed to evaluate the safety and efficacy of two proven cardiac therapies combined — CCM® and an implantable cardioverter defibrillator (ICD) — in a single device (CCM-D). The Optimizer® IntegraTM CCM-D System delivers CCM therapy to improve quality of life and reduce heart failure symptoms, and ICD therapy to treat life-threatening arrhythmias that may cause sudden cardiac death. The investigational technology is rechargeable with long battery life, potentially reducing the need for replacement procedures.

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Impulse Dynamics Launched Optimizer Smart Mini in April 2022

Posted on by Posted in Cardiac Contractility Modulation, Cardiac Stimulation (other), David Prutchi's Portfolio, Heart Failure (CHF), Impulse Dynamics, My Portfolio
Impulse Dynamics OPTIMIZER Smart Mini IPG by Impulse Dynamics

Image Credit: Impulse Dynamics

Back on April 29, 2022, Impulse Dynamics, the company where I am the CTO and Executive VP of Product Development, announced both FDA and CE Mark approval and the official commercial launch of the Optimizer® Smart Mini System.

According to the press release:

The Optimizer Smart Mini delivers CCM therapy — Impulse Dynamics’ proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM therapy is indicated to improve 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent.

The OPTIMIZER Smart Mini offers increased battery longevity of 20 years (compared to 15 years in the previous generation), advanced HF diagnostic monitoring capabilities (e.g., heart rate, heart rate variability, patient posture and position), and remote patient monitoring features that will be activated in the near future.

Renewing Activity on Implantable-Device.com

Posted on by Posted in Administrative

I haven’t updated this blog in over a year, mostly because of issues with my hosting provider.  I finally got fed up with them and migrated the website to a new host, which so far has proven to be fast and reliable.

Much has happened in our Industry over the last year, so I have a lot to catch up on this blog.  I’ve also added historical IPGs to my collections, so telling their story is another thing that I need to do.

I hope you visit often to read the updates!

– David

Resonetics buys EaglePicher’s medical battery division

Posted on by Posted in AIMD Business, Eagle Pitcher, Resonetics
Resonetics implantable-grade battery

Image Credit: Resonetics

Resonetics announced  that it has acquired EaglePicher Technologies’ Medical Power business, a leading manufacturer of implantable batteries for critical medical devices based near Vancouver, British Columbia.

Resonetics was founded in 1987 as a provider of engineering and manufacturing solutions for the life sciences industry. Resonetics offers laser processing, centerless grinding, nitinol processing, thin-wall stainless steel & precious metal tubing, photochemical machining, microfluidics manufacturing, and sensor technology.  The acquisition of EaglePicher’s medical battery division expands on the components that it can provide to the AIMD industry.

From the announcement:

“EaglePicher Medical Power has been designing and manufacturing batteries for medical devices for over 25 years and produced one of the first lithium-ion cells for an implantable medical device. The Vancouver site features a modern 60,000 square foot facility with extensive application engineering resources and manufacturing expertise. Chris Huntington, President, EaglePicher Medical Power, will join Resonetics as its Chief Commercial Officer.”

Intelligent Implants’ SmartFuse TLIF Cage to Aid Spinal Fusion

Posted on by Posted in Bone Fracture/Fusion, Bone Growth Stimulation, Intelligent Implants

Image Credit: Intelligent Implants

Intelligent Implants is a company based in Cork, Ireland.  Their SmartFuse® platform is a wirelessly enabled orthopedics platform that has been designed to remotely stimulate, control, and monitor bone growth. The goal of the SmartFuse system is to accelerate bone growth and provide remote monitoring of the patient to support real-time clinical decision-making. The first indication for the SmartFuse system will be for use in lumbar spinal fusions.

In an interview with MedGadget, Intelligent Implants’ CEO Ben Hertzog said about the implants’ remote monitoring functions:

“In addition to stimulation, we can also use the implant to measure the electrical properties of the surgical site. The electrical properties of the mature (healed) bone are quite different than that of the immediate post-operative surgical site, so by measuring these properties, over time, we can actually detect the new bone being formed and present this data to the surgeon in a way that is indicative of healing. Our SmartFuse Cloud system enables the physician to access the data in real-time. We can also track patient compliance and system status. Overall, we can provide the surgeon with an unprecedented view into the patient’s post-operative journey, including how well they are healing. We believe this ability to accelerate bone growth AND monitor healing and patient compliance has the potential to improve outcomes dramatically.”

FDA granted SmartFuse with Breakthrough Technology designation back in May of 2021.

Impulse Dynamics Implants First Patient in AIM HIGHer Trial to Treat HF with High EF

Posted on by Posted in Cardiac Contractility Modulation, Heart Failure (CHF), Impulse Dynamics, My Portfolio

On March 14, 2022, Impulse Dynamics (of which I am the CTO and Executive VP) conducted the first implant of a patient in its AIM HIGHer trial.  The goal of the blinded study is to evaluate the performance of CCM Therapy  to treat heart failure in a population with high ejection fraction (LVEF between 40% and 60%, inclusive).

According to the press release:

“Patients can have HF with severely reduced, moderately reduced, or even preserved ejection fraction (e.g., EF close to the normal range of 60% or above.) Those patients with severely reduced or moderately reduced EF have therapeutic options, including many classes of pharmaceuticals and device therapies such as CCM. However, HF patients with higher EF (e.g., above 40%) have had few therapeutic options thus far to alleviate their symptoms and treat their disease. The purpose of AIM HIGHer is to assess the potential of CCM to improve performance and reduce cardiovascular morbidity and mortality for these patients.

…

The Optimizer delivers cardiac contractility modulation therapy — a proprietary technology of Impulse Dynamics — to the heart. Impulse Dynamics has designed CCM therapy to significantly improve heart contraction, allowing more oxygen-rich blood to be pushed out through the body. This breakthrough device has demonstrated its capability of enhancing the quality of life for HF patients no longer responding adequately to medication meant to manage their symptoms.”

AIM HIGHer is the largest randomized sham-controlled therapeutic cardiac device trial to ever be conducted.

Axonix Receives FDA Approval for F15 Stimulator for Treating Bladder and Bowel Dysfunction

Posted on by Posted in Axonics, Bowel Discfunction, Incontinence, Sacral Root Stimulation

 

Image Credit: Axonix

On March 7, 2022 Axonix announced that it had received FDA Approval for its 10cc F15 Recharge-Free Sacral Neuromodulation System for the treatment of bladder and bowel dysfunction.  The device features 15+ years of functional life at typical stimulation parameters and 20+ years at lower energy settings.

 

LivaNova starts clinical trial on ImThera’s device for Obstructive Sleep Apnea

Posted on by Posted in Hypoglossal Neurostimulation, ImThera Medical, LivaNova, Obstructive Sleep Apnea
ImThera IPG

Image Credit: LivaNova

In December 2017, LivaNova acquired San Diego-based ImThera – a privately held company focused on neurostimulation for the treatment of obstructive sleep apnea (“OSA”).

The aura6000 is based on ImThera’s Targeted Hypoglossal Neurostimulation (THN) Sleep Therapy™ delivering neurostimulation to the tongue during sleep. The system is comprised of a surgically‐placed multi‐contact electrode specifically designed for the Hypoglossal nerve, and a lead that connects the electrode to a programmable, rechargeable implantable pulse generator (IPG) that is placed in the anterior chest wall. The device delivers muscle tone to key tongue muscles, preventing the tongue from collapsing into the upper airway, thus permitting normal breathing during sleep.

In March 2022, LivaNova announced that it had implanted the first patient with an InThera aura6000 in the “OSPREY” “Treating Obstructive Sleep Apnea using Targeted Hypoglossal Neurostimulation” IDE trial

Medtronic Receives FDA Approval for Interstim X™ for Bowel and Bladder Control

Posted on by Posted in Bowel Discfunction, Incontinence, Medtronic, Sacral Root Stimulation

Image Credit: Medtronic

Medtronic announced that it received approval from the U.S. Food and Drug Administration (FDA) for its InterStim X™ sacral neuromodulation system for the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention.

According to the announcement, the InterStim X device features a proprietary 5th generation battery chemistry that offers more than 10 years of battery life without the need to recharge, providing patients with more freedom and less maintenance. With low energy settings, the device may last up to 15 years.

What Happens to Patients when AIMD Company Vanishes? IEEE Damning Report of Second Sight

Posted on by Posted in Blindness, Retinal Stimulation, Second Sight
Second Sight Argus II Retinal Prosthesis www.implantable-device.com David Prutchi PhD

Image Credit: Second Sight

IEEE published a damning report on Second Sight’s lack of support for patients who were implanted with their Argus and Argus II retinal prostheses.  It is unfortunate that investors and creditors are placed in font of patients who act as subjects to advance our Industry.  As the IEEE report puts it:

“After Second Sight discontinued its retinal implant in 2019 and nearly went out of business in 2020, a public offering in June 2021 raised US $57.5 million at $5 per share. The company promised to focus on its ongoing clinical trial of a brain implant, called Orion, that also provides artificial vision. But its stock price plunged to around $1.50, and in February 2022, just before this article was published, the company announced a proposed merger with an early-stage biopharmaceutical company called Nano Precision Medical (NPM). None of Second Sight’s executives will be on the leadership team of the new company, which will focus on developing NPM’s novel implant for drug delivery.”

This is not the first time that the fate and interest of patients have been been placed behind that of investors and creditors.  James Cavuoto, the Editor of Neurotech Reports proposed solutions a few years ago after a number of neurostim companies closed their doors:

‘Bankruptcy courts should put implanted patients high on the priority list of creditors. Firms or institutions that volunteer to support existing patients should get IP priority on any technology that was used. And the government should underwrite funds needed for ongoing care of orphaned patients. We owe it to patients to live up to the adage, “Do no harm.” ‘

 

 

Second Sight Acquires Drug-Delivery Company Nano Precision Medical

Posted on by Posted in Diabetes, Drug Delivery, Second Sight

From US9814867B2 – Device having titania nanotube membrane for drug delivery

Visual prosthesis maker Second Sight announced that it will issue 134M shares to acquire full ownership of Nano Precision Medical. Second Sight shareholders will own ~23% of the combined company.

Nano Precision Medical is based in the San Francisco Bay Area, and has been developing miniaturized implants using their proprietary NanoPortal™ technology for the delivery of medicines to treat chronic diseases.  Looking through cofounder Adam Mendelosohn’s patents shows passive implants that control the rate of release of therapeutic substances from a reservoir by the use of nanoporous membranes.  NPM’s lead program, NPM-119, is a near clinical stage GLP-1 receptor agonist which is being developed to treat patients with Type 2 diabetes for up to 6 months.

Second Sight had a somewhat rocky 2020 and 2021.  In 2020 they winded down operations, and then in 2021 combined with Pixium Vision.  Now they seem to be diversifying by adding completely different business fields within the implantables industry.  According to the press release:

“According to Second Sight Chairman of the Board Gregg Williams, “The merger with NPM aligns with our expanded vision to become a top device and drug implant company, allows us immediate access to NPM’s experienced executive leadership team, and provides the two companies with a myriad of opportunities to leverage potential synergies.” “

 

 

Abbott Implants World’s First Dual-Chamber Leadless Pacemaker

Posted on by Posted in Abbott, Bradycardia, Cardiac Pacing

Image Credit: Abbott

Abbott announced today the world’s first patient implants of a dual-chamber leadless pacemaker system as part of its AVEIR DR i2i™ pivotal clinical study.  Abbott’s “i2i technology” is used to provide beat-by-beat communication between two leadless pacemakers, one positioned in the right ventricle and one positioned in the right atrium to allow for true dual-chamber leadless pacing.

The Aveir DR i2i study is a prospective, multicenter, international, single-arm, pivotal investigational study designed to evaluate the clinical safety and efficacy of the Aveir DR leadless pacemaker in patients who were indicated for a DDD(R) pacemaker.   The study plan is to enroll up to 550 patients from up to 80 sites, and all patients will be followed for a minimum of 12 months post-implant.

Boston Scientific Results for Q4 21 and Full-Year 2021: CRM/Neuro 11.8% up (Q4), 19.7% (FY21)

Posted on by Posted in AIMD Business, Boston Scientific

Boston Scientific Logo

Boston Scientific announced its financial results for Q4 and full-year 2021, reporting a Q4 growth in Rhythm and Neuro of 11.8% reported basis, 13.2% operational, and 6.1% organic.  CRM had 14% growth, and Neuromodulation 5.2%.  For the full year, Rhythm and Neuro grew by 19.7% (reported basis), with CRM growing by 18.5% and Neuromodulation by 19.5%.

The press release mentioned the following implantable-related developments:

  • “Initiated the MODULAR ATP clinical trial to evaluate the safety, performance and effectiveness of the mCRM™ Modular Therapy System. The mCRM System consists of two cardiac rhythm management devices intended to work together to coordinate therapy: the EMBLEM™ MRI Subcutaneous Implantable Defibrillator System and the EMPOWER™ Modular Pacing System, designed to be the first leadless pacemaker capable of delivering both bradycardia pacing support and antitachycardia pacing (ATP).

  • Presented positive late-breaking clinical trial data on the COMBO randomized control trial at the 2022 North American Neuromodulation Society (NANS) meeting demonstrating the durable effectiveness of the WaveWriter™ Spinal Cord Stimulator (SCS) System, capable of delivering combination therapy for the treatment of chronic pain, designed to offer more opportunities to customize SCS therapy and optimize outcomes.”

 

FDA Panel Rejects BrainsGate’s Spheno-Palatine Ganglion Stimulator to Treat Ischemic Stroke

Posted on by Posted in Brainsgate, Ischemic Stroke, Sphenopalatine Ganglion Stimulation, Yossi Gross (Rainbow Medical)

Image Credit: BrainsGate

BrainsGate is an Israeli company that was established in 2000.  It developed an implantable device for the stimulation of the Spheno-Palatine Ganglion (SPG) to modulate the brain-blood barrier and increase cerebral blood flow.

On December 10, 2021, BrainsGate’s clinical study was discussed by an FDA panel, which although agreed on the safety of the system, did not find the device sufficiently effective as a treatment for stroke, whereby its benefits would outweigh the risks.

The voting was:

  • Safety:  13 votes in favor
  • Effectiveness: 3 votes in favor, 7 against, 3 abstain
  • Benefits outweigh risk: 3 votes in favor, 7 against, 3 abstain

FDA does not have to follow the recommendations of its panels, but it mostly does (approximately 80% of the time), and such low vote of confidence does not bode well for BrainsGate’s SPG stimulation as a treatment for ischemic stroke.

Image Credit: BrainsGate

 

Boston Scientific Starts Trial of EMBLEM™ S-ICD with EMPOWER™ Leadless Pacemaker

Posted on by Posted in Boston Scientific, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Tachycardia

Image Credit: Boston Scientific

Boston Scientific announced that it has initiated the MODULAR ATP clinical trial to evaluate the safety, performance and effectiveness of the mCRM™ Modular Therapy System. The mCRM System consists of the EMBLEM™ MRI S-ICD and the EMPOWER™ Modular Pacing System (MPS), which is designed to be the first leadless pacemaker capable of delivering both bradycardia pacing support and antitachycardia pacing (ATP).

The EMPOWER leadless pacemaker is meant to complement the S-ICD System by providing the ability to deliver Antitachycardia Pacing (ATP).

I’m interested in how leadless pacemakers pacemakers will fare given FDA’s recent warning of serious complications after implantation of Medtronic’s Micra leadless pacemaker.