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

Monthly Archives: October 2019

Boston Scientific Reports Q3 2019: CRM up 0.6%, Neuromodulation up 17.5%

Posted on by Posted in AIMD Business, Boston Scientific

Boston Scientific Logo

Boston Scientific announced today its financial results for Q3 2019.  According to the press release, Cardiac Rhythm Management went up from $475M in Q3 2018 to $478M in Q3 2019.

In its neuromodulation business, Q3 2019 brought $222M compared to $189M for the same period last year.

Among recent developments, Boston Scientific “Announced the U.S. Food and Drug Administration (FDA) approval of ImageReady™ MRI labeling for the Vercise Gevia™ Deep Brain Stimulation (DBS) System to be used in a full-body magnetic resonance imaging (MRI) environment .”

GTX and NeuroRecovery Technologies Merge

Posted on by Posted in GTX Medical, Spinal Cord Injury (SCI), Spinal Cord Stimulation

Image Credit: GTX Medical

GTX Medical of The Netherlands and Switzerland, and NeuroRecovery Technologies, of San Juan Capistrano, California announced they intend to merge as GTX Medical with the goal of developing devices for restoring movement and the ability to walk in patients with paralysis and spinal cord injuries.

Shareholders and investors include the  Christopher and Dana Reeve Foundation, LSP, Inkef, Wellington Partners, and GIMV.

The joint company will focus on developing two technologies to improve the functional recovery of people with spinal cord injuries:

  1. Targeted Epidural Spine Stimulation (TESS) – an implantable spinal cord stimulation system with real-time motion feedback
  2. Transcutaneous Spinal Cord Stimulation (tSCS) – a noninvasive device aimed at restoring upper limb movement and hand function

Medtronic Initiates Worldwide Pivotal Study for its Extravascular ICD

Posted on by Posted in Cardiac Pacing, Cardioversion/Defibrillation, Medtronic, Tachycardia
Medtronic EV ICD

Image Credit: Medtronic

Medtronic announced today that it started a worldwide pivotal study evaluating its investigational Extravascular Implantable Cardioverter Defibrillator (EV ICD) system. The EV ICD system is designed to deliver lifesaving defibrillation and pacing therapy via a device the same size as traditional, transvenous ICDs, but with an extravascular lead placed outside the heart and veins.

According to the press release:

“The EV ICD pivotal study is a prospective, multicenter, single-arm, non-randomized, pre-market clinical study that will assess the Medtronic EV ICD system in up to 400 patients at up to 60 sites in North America, Europe, the Middle East, Asia, Australia and New Zealand.

The study’s primary effectiveness endpoint is defibrillation testing success rate at implant. The primary safety objective is freedom from major system and/or procedural complications at six months after implant. Patients will be assessed at two weeks, three months, six months, and every six months thereafter.”

Medtronic Submits InterStim™ Micro Neurostimulator to FDA

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

Image Credit: Medtronic

Medtronic announced today that it had submitted its new InterStim™ Micro neurostimulator and matching InterStim™ SureScan™ MRI leads for PMA approval by FDA.

According to the press release:

“InterStim Micro is a rechargeable, implantable sacral neuromodulation (SNM) device to treat patients affected by overactive bladder, urinary urge incontinence, unobstructed urinary retention and fecal incontinence. The SureScan™ leads, which will be used in future implants of the recharge-free InterStim II system and rechargeable InterStim Micro system, are designed to provide full-body 1.5 and 3 Tesla MRI conditional labeling, pending FDA approval.”

It’s not common for companies to announce their submissions – usually one waits for approval – but this may be Medtronic’s way of signaling the market that it’s not far behind Axonics, which received FDA approval for a similar device last month.