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

Monthly Archives: February 2022

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.”