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

Monthly Archives: March 2022

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