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

FDA/CE MR-Conditional Approvals for Impulse Dynamics’ OPTIMIZER Smart IPG

Posted on by Posted in Heart Failure (CHF), Impulse Dynamics, MRI-safe, My Portfolio

Impulse Dynamics – the company for which I am CTO and Executive VP – received MR-conditional approval (1.5 T head/limbs with peripheral coils) from both FDA and the European Union.

From the press release:

IMPULSE DYNAMICS ANNOUNCES FDA APPROVAL FOR MAGNETIC RESONANCE IMAGING FDA

Clears Potential Hurdle for Many Heart Failure Patients

MARLTON, N.J.–(BUSINESS WIRE)–Impulse Dynamics, a company dedicated to improving the lives of people with heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has approved the conditional use of Magnetic Resonance Imaging (MRI) for Optimizer® CCM® delivery systems. This approval represents a significant advance because the population that benefits most from cardiac contractility modulation therapy (patients with moderate to severe HF) often requires advanced diagnostic imaging procedures.

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FDA Clears Vital Data Sensor in Biotronik’s Biomonitor IIIm ICM

Posted on by Posted in Atrial Flutter/Fib, Biotronik, Bradycardia, ECG Monitoring

Image Credit: Biotronik

FDA has cleared Biotronik’s Vital Data Sensor to identify body temperature increases potentially associated with fever as part of its new Biomonitor IIIm injectable cardiac monitor (ICM).

The device has shown to achieve a 72 percent reduction in false positives while maintaining 100 percent of AF-related sensitivity. It removes single ectopic beats out of the AF detection algorithm, enhancing diagnostic accuracy.

According to Biotronik, “BIOMONITOR IIIm is the industry leader in battery longevity with 5.5 years of continuous service, providing long-term post-ablation or cryptogenic stroke monitoring. It is also backed by the Patient App, which allows patients to include vital symptom data, providing physicians with symptom-rhythm correlation which strengthens diagnostic precision.”

Astellas Acquires Iota Biosciences for $304M

Posted on by Posted in AIMD Business, Neural Stimulation, Ultrasound

Image Credit: iota Biosciences

iota Biosciences was established in 2017, building up on the concept of “neural dust” technology invented at the University of California, Berkeley by iota co-founders and co-CEOs Jose Carmena, Ph.D. and Michel Maharbiz, Ph.D.

iota’s “neural dust” consists of a small implantable device (a few mm long) that is powered from an external ultrasound generator. According to iota, their devices can record electrical information, stimulate nerves and communicate with other machines through ultrasound. Iota claims that “neural dust” devices can modulate the information transmitted through nerves, enabling doctors to better treat conditions from arthritis to cardiovascular disease

In 2018 iota completed a $15 million series A funding round aimed at developing a sensing platform. In September 2019, iota entered into a joint R&D agreement with Japanese Astellas Pharma to “design detailed specifications of implantable medical devices and conduct preclinical studies for several diseases with high unmet medical needs.”

Astellas today announced that it would acquire Iota in a deal that includes an initial payment of about $127.5M, covering the equity that Astellas did not acquire in 2018.  An additional $176.5M are development-related milestone payments.  Iota will be an independent subsidiary under Astellas’ U.S. umbrella.

Eventually, iota hopes to shrink the device to the size of grain of sand that can simultaneously sense neural activity and stimulate nerves to enable highly-targeted closed-loop therapies.

iota Biosciences’ website is at: https://iota.bio/

CCM Therapy Delivered by the Optimizer System Wins R&D 100 Award

Posted on by Posted in Cardiac Stimulation (other), David Prutchi's Portfolio, Heart Failure (CHF), Impulse Dynamics

Impulse Dynamics, Inc., a company dedicated to improving the lives of people with heart failure, today announced its innovative CCM® therapy delivered by the Optimizer® system received an award from the R&D 100 Awards, a prestigious program honoring research and development pioneers and their revolutionary ideas in science and technology.

“Winning this award is a tremendous accomplishment for our company as it represents the recognition by fellow scientists and engineers for the enormous effort that has gone into developing this breakthrough technology. The therapy serves a huge unmet need for a very large group of heart failure patients who suffer every day with their symptoms, so it’s great for the technology to receive recognition at this level,” said David Prutchi, Ph.D., Chief Technology Officer and Executive Vice President at Impulse Dynamics. “I am pleased to congratulate all my colleagues that helped evolve what was initially an intriguing electrophysiological discovery into the transformational therapy that it is today.”

Impulse Dynamics’ website: www.impulse-dynamics.com

CVRx® Publishes Results of BeAT-HF Trial in JACC

Posted on by Posted in Baroreceptor Stimulation, CVRx, Heart Failure (CHF)

Image Credit: CVRx

CVRx’s BeAT-HF phase III randomized clinical trial results were published in the Journal of the American College of Cardiology (“JACC”). Results from the trial were used to obtain FDA PMA for the BAROSTIM NEO device for improvement of symptoms in patients with heart failure.

The main results for the study were:

  • BAROSTIM NEO is safe to use for patients with HFrEF, with a MANCE-free rate of 97%.
  • Clinically-significant improvements in patient-centered symptomatic endpoints as compared to the control group:
    • Improved quality of life score by 14.1 (p<0.001) points in MLWHFQ.
    • Improved exercise capacity by 60 meters (p<0.001) as measured by the standardized 6-minute hall walk test.
    • Improved functional status as assessed by NYHA classification: 65% BAROSTIM NEO versus 31% control patients experienced NYHA class improvement (p<0.001).
  • Significant 25% reduction in NT-proBNP (p<0.001).

FDA Approves Abbott’s Gallant ICD and CRT-D Line

Posted on by Posted in Abbott, Cardioversion/Defibrillation, Heart Failure (CHF), Tachycardia
Abbott Gallant ICD CRT-D family with Bluetooth connection www.implantable-device.com

Image Credit: Abbott

Abbott today announced that the FDA has approved its next-generation Gallant™ line of ICD and CRT-D devices. According to the announcement:

“The devices bring new benefits to patients with heart rhythm disorders, including a patient-preferred design without compromising battery longevity and MRI compatibility. In addition, the new devices offer Bluetooth technology and a new patient smartphone app for improved remote monitoring, allowing for increased patient/physician engagement and streamlined communications.

The new Gallant system pairs with Abbott’s secure myMerlinPulse™, an iOS- and Android™- compatible mobile smartphone app that helps streamline communication between doctors and their patients. The app provides people with access to data, device performance, and transmission history, which helps them take an active role in their healthcare. Through the myMerlinPulse app, physicians can continuously monitor their patients remotely allowing for identification of asymptomatic episodes as well as patient-triggered transmissions, which can lead to earlier intervention and reduce clinical burden.”

Abbott received the CE Mark for these devices back in February 2020.

FDA Clears Boston Scientific’s LUX-Dx™ Insertable Cardiac Monitor

Posted on by Posted in Boston Scientific, ECG Monitoring

Image Credit: Boston Scientific

FDA has 510(k)-cleared the LUX-Dx™ Insertable Cardiac Monitor (ICM), which is a long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope

According to the announcement:

“The new LUX-Dx ICM System is designed with a dual-stage algorithm that detects and then verifies potential arrhythmias before an alert is sent to clinicians, thereby providing actionable data for clinical decision-making. Further, the remote programming capabilities of the device via the LATITUDE Clarity™ Data Management System website allow physicians and care teams to adjust event detection settings without requiring an in-person patient appointment, a feature unavailable on any other ICM currently on the market.

…

The dual-stage algorithm within the LUX-Dx ICM System can be programmed to identify AF, atrial flutter, rhythm pause, bradycardia and tachycardia episodes and allows the device to detect arrhythmias each time established thresholds or parameters are exceeded. An additional level of verification filters is then applied, which was developed to catch false positive detections before an alert is sent. Additionally, after implant, patients are provided with a mobile device preloaded with the MyLUX™ app which connects via Bluetooth® to their ICM device. The app transmits device data daily, or as needed, to the LATITUDE Clarity Data Management System giving physicians and care teams timely access to vital information.”

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Medtronic Receives Approval for its Percept™ PC Neurostimulator with BrainSense™ Technology

Posted on by Posted in Brain Stimulation, Epilepsy, Medtronic, OCD, Parkinson's Disease

Image Credit: Medtronic

Medtronic announced that it received FDA approval for the Percept™ PC Deep Brain Stimulation (DBS) system.

According to the announcement:

“BrainSense™ technology makes Percept the first and only DBS neurostimulation system with the ability to chronically capture and record brain signals while delivering therapy to patients with neurologic disorders associated with Parkinson’s disease, essential tremor, dystonia, epilepsy or obsessive-compulsive disorder (OCD). Physicians can now track patient brain signals and correlate these with patient-recorded actions or experiences, such as symptoms, side-effects, or medication intake. This enables more personalized, data-driven neurostimulation treatment.

…

In addition to BrainSense technology, the Percept PC DBS system features several leading-edge innovations, including:

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Setpoint Medical Receives FDA IDE Approval to Implant its “Microregulator” for Treating Rheumatoid Arthritis

Posted on by Posted in Rheumathoid Arthritis, SetPoint Medical, Vagus Nerve Stimulation

Image Credit: SetPoint Medical

SetPoint Medical is a company based in Valencia, California developing an implantable-device-based therapy for chronic autoimmune diseases.  It announced in May that it has received FDA IDE approval to study its device in patients with rheumatoid arthritis (RA).

The multicenter, double-blind, randomized, sham controlled pivotal trial will enroll up to 250 patients at 40 sites across the U.S. The trial will evaluate the safety and effectiveness of the SetPoint “microregulator” in patients with moderate-to-severe RA who are incomplete responders or are intolerant to biologic or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs).

Neuspera Medical Implants first of its Miniature Sacral Stimulators in Clinical Trial for the Treatment of Urinary Urgency Incontinence

Posted on by Posted in Incontinence, Neuspera, Neuspera Mid Field Powering, Sacral Root Stimulation

Image Credit: Neuspera Medical

Neuspera is a startup company located in San Jose, CA.  They are developing miniaturized neuromodulation implants that are externally powered from a wearable device.

According to Neuspera, their “Mid-Field Powering” technology uses evanescent and propagating electromagnetic waves to power implanted medical devices to beyond 10cm of depth. Their technology is claimed to use the body as a natural waveguide to focus power ensuring energy is delivered to where it is needed.

In December 2019, Neuspera announced that it had received FDA’s approval to implant their systems under IDE.  Neuspera now announced that it had performed the first human implants as part of their SANS-UUI two-stage seamless pivotal clinical trial to support FDA approval for patients with Urinary Urgency Incontinence (UUI), a symptom of overactive bladder.

Neuspera’s website: http://neuspera.com

Image Credit: Neuspera Medical

Cirtec buys Nuvectra’s Assets

Posted on by Posted in AIMD Business, Brain Stimulation, CCC Medical, Cirtec, Engineering & OEM Services, Integer, Nuvectra, Sacral Root Stimulation, Spinal Cord Stimulation

Image Credit: Nuvectra

Back in 2013, implantable-grade component manufacturer Greatbatch Medical (now Integer Holdings) briefly entered the finished devices market with its own Algostim Spinal Cord Stimulator.

However, when Greatbatch acquired CCC Medical in 2014, having the Algostim SCS was seen as a conflict of interest by some of CCC’s SCS customers (e.g. Nevro), so in 2015/2016 Greatbatch divested its SCS business into a new company called Nuvectra.

Nuvectra never caused much of an impact in the SCS market, and trailed well behind Abbott, Boston Scientific, Medtronic, and Nevro.  After limping along for a number of years, on November 12, 2019, Nuvectra filed for Chapter 11 bankruptcy.

Cirtec Medical, a competitor of Integer’s CCC in the development of implantable devices, acquired Nuvectra’s IP and assets. Cirtec intends to leverage this technology to support customers’ development of neuromodulation products, providing an FDA approved platform with a complete design history file for a variety of therapeutic applications.

The Nuvectra assets acquired by Cirtec include all owned intellectual property associated with the SCS, SNS, and DBS platforms developed by Nuvectra.

FDA Approves Mainstay Medical’s ReActiv8 Neurostimulator

Posted on by Posted in Mainstay Medical, Muscular Stimulation, Pain

Image Credit: Mainstay Medical

Dublin, Ireland-headquartered Mainstay Medical announced that FDA has approved its ReActiv8 neurostimulator is intended to treat chronic low back pain caused by arthrogenic muscle inhibition.  This is a neuroprotective condition in which the brain reflexively attempts to limit motor stimulation and movement in muscles surrounding a joint in response to damage or injury to the joint. In patients with this type of back pain, an initial injury triggers this reflexive inhibition, and the brain tries to limit painful movement by altering nerve transmissions to the deep stabilizing muscles of the spine, causing a loss of motor control, an unstable spine, and greater susceptibility to reinjury.

According to Mainstay, arthrogenic muscle inhibition causes the vicious cycle of recurring pain, instability, and reinjury commonly seen in patients with chronic nonspecific low back pain.  The ReActiv8 System attempts to interrupt this cycle by using neurostimulation to reactivate the motor control system driving the deep stabilizing muscles of the spine.  Stimulation is delivered via two leads which are placed bilaterally near the medial branch of the dorsal ramus nerve at the L3 vertebra.  An external wireless activator is used to start and stop stimulation sessions typically for 30 minutes twice a day.

According to the announcement:

“The FDA approval grants Mainstay the right to market ReActiv8 in the United States as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging or physiological testing in adults who have failed therapy, including pain medications and physical therapy, and are not candidates for spine surgery.”

Benchmark Electronics Closes Angleton Plant

Posted on by Posted in AIMD Business, Intermedics (1974-1999)

My ex-colleagues from Intermedics may remember the Benchmark Electronics plant across the street in Angleton that used to manufacture some of our external devices.  Benchmark announced that it plans  to close the Angleton facility within a year, impacting approximately 190 plant employees.

Benchmark Electronics was founded in 1979 as “Electronics, Inc.”  in Clute, Texas, as a manufacturing subsidiary to Intermedics. The company specialized in low-volume, complex assembly of medical products.  It was bought from Intermedics by its managers in 1986, and went public in 1990.   In 1994 Benchmark moved its headquarters to 3000 Technology Drive in Angleton, right across from Intermedics’ headquarters.

Benchmark continued growing, acquiring along the way plants and design centers in the US, Europe, and Asia.

In 2017 Benchmark Electronics relocated its corporate headquarters to Arizona so it could consolidate corporate headquarters staff in one location, expand its engineering capabilities through a partnership with Arizona State University, and position the company closer to its aerospace and defense customers.

On June 4, 2020, Benchmark will shutter the 109,000 sq. ft. plant in Angleton at some point between Jan. 1 and Jul. 1, 2021. According to the announcement, workers from the Angleton plant will be eligible to apply for open positions in other company locations.

 

Second Sight (Developer of Implantable Visual Prosthetics) Winds Down Operations

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

Image Credit: Second Sight Medical

Second Sight Medical Products, a developer, manufacturer and marketer of implantable visual prosthetics that are intended to create an artificial form of useful vision for blind individuals, announced in March that because of the impact of COVID-19 on its ability to secure financing, it would lay off the majority of its employees as a first step to an orderly wind-down of its operations.

Second Sight had created the only FDA-approved implantable visual prosthetic treatment (Argus II) for severe retinitis pigmentosa.  To date, more than 350 patients have received an Argus II implant.  More recently, the company developed the Orion implant, which is placed directly onto the visual cortex of the patient’s brain. Signals received from a miniature camera integrated within a pair of glasses are fed to the implant and interpreted as “vision” by the brain.  At the time of the closure announcement, the company was conducting a feasibility study with the Orion device implanted in six blind patients.  Second Sight had been working towards a larger “pivotal” trial of the Orion implant, while all of the patients taking part in the small-scale study had reached the 12-month mark.

The closure announcement was made shortly after Second Sight provided its 2019 financials that showed  an operating loss of $34 million during the year, on sales of less than $4 million.  Operating capital came mostly from $35 million cash that the company raised in a shareholder rights issue about a year ago.

On May 5, 2020, Second Sight closed an offering of its common stock worth approximately $6.8 million.  Second Sight intends to use the proceeds for “accrued expenses, working capital and general corporate purposes. Those expenditures may include partnerships, business combinations, acquisitions or investments.”

Second Sight Medical’s assets are going up for auction tomorrow (June 25):

“The auction will feature Second Sight’s medical device manufacturing equipment, laboratory assets and office furniture located in Sylmar, Calif. Items available include laser systems, oscilloscopes, spectrum analyzers, scientific microscopes, laboratory refrigerators and freezers, ultrasonic cleaners, vacuum pumps, probe systems, computers, office equipment and more, according to a auction company GA Global Partners.”