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

Monthly Archives: June 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.

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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.

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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.”