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

Category Archives: Boston Scientific

What happened to the BION®?

Posted on by Posted in Advanced Bionics, Alfred E. Mann, Axonics, Bluewind Medical, Boston Scientific, Electrode Materials, General Stim, Incontinence, Muscular Stimulation, Nalu, Neural Stimulation, Neuspera, Paralysis, University of Southern California, Valencia Technologies
RF-powered Bion stimulator

First-generation RF-powered BION (RFB1) microstimulator. Image Credit: Alfred Mann Institute for Biomedical Engineering

In 1991, Dr. Gerald Loeb, at the time a Professor of Physiology and Biomedical Engineering at Queen’s University (Kingston, Canada), first proposed a miniature, injectable, RF-powered device for the stimulation of tissue or motor neurons. The BION® device was developed based on this concept as a joint project between Queens University (Kingston, ON, Canada), IIT (Chicago, IL), and the Alfred E. Mann Foundation (Valencia, CA) with funding from the NIH Neural Prosthesis Program. The RF BION 1 (RFB1) was then manufactured by the Alfred Mann Institute for Biomedical Engineering at USC.

Continue reading→

FTC scrutinizing Boston Scientific’s $3.7B bid to acquire Axonix

Posted on by Posted in AIMD Business, Axonics, Boston Scientific, Incontinence, Sacral Root Stimulation
Axonix rechargeable stimulator

Image Credit: Axonix

In January of this year Boston Scientific announced it had entered into a definitive agreement to acquire Axonics a publicly-traded developer of devices to treat urinary and bowel dysfunction. The purchase price was set at  $3.7B.     However, the proposed deal is facing scrutiny by the FTC, most probably because the companies are dominant providers of some treatments for incontinence.

The Axonics product portfolio includes the Axonics R20 and the Axonics F15 Systems used to deliver sacral neuromodulation (SNM) therapy. In clinical studies, Axonics Therapy has demonstrated meaningful improvement in patients’ quality of life in follow-up out to two years, with no serious device-related adverse events reported.

Boston Scientific Acquires Axonics

Posted on by Posted in AIMD Business, Axonics, Boston Scientific, Incontinence, Sacral Root Stimulation

Image Credit: Axonix

Boston Scientific Corporation  announced it has entered into a definitive agreement to acquire Axonics, a company that develops implantable sacral neuromodulation devices to treat urinary and bowel dysfunction. According to the announcement, the purchase price is $71 in cash per share, reflecting an equity value of approximately $3.7 billion.

 

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.”

 

Boston Scientific Starts Trial of EMBLEM™ S-ICD with EMPOWER™ Leadless Pacemaker

Posted on by Posted in Boston Scientific, Bradycardia, Cardiac Pacing, Cardioversion/Defibrillation, Tachycardia

Image Credit: Boston Scientific

Boston Scientific announced that it has initiated the MODULAR ATP clinical trial to evaluate the safety, performance and effectiveness of the mCRM™ Modular Therapy System. The mCRM System consists of the EMBLEM™ MRI S-ICD and the EMPOWER™ Modular Pacing System (MPS), which is designed to be the first leadless pacemaker capable of delivering both bradycardia pacing support and antitachycardia pacing (ATP).

The EMPOWER leadless pacemaker is meant to complement the S-ICD System by providing the ability to deliver Antitachycardia Pacing (ATP).

I’m interested in how leadless pacemakers pacemakers will fare given FDA’s recent warning of serious complications after implantation of Medtronic’s Micra leadless pacemaker.

Boston Scientific Recalls 48,000 Ingenio Pacemakers

Posted on by Posted in Boston Scientific, Bradycardia, Cardiac Pacing, Heart Failure (CHF)

Boston Scientific has recalled approximately 48,000 Ingenio pacemakers and cardiac resynchronization devices distributed between November 2011 and August 2020.  The potentially defective devices, which were manufactured only through December 2018, are no longer available for implant. The recall was initiated on June 3, 2021, and now FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

There have been 65 reported incidents, including three injuries which required patients to receive temporary external pacing. There have been no reports of death.

The issue is that after several years of use, the batteries  reach a high level of internal impedance. At that point, a sudden decrease in battery voltage may occur during telemetry, incorrectly triggering a system reset. If the system resets three times within 48 hours, it’s sent into safety mode.  However, in safety mode, there is a risk of inappropriate loss of pacing due to sensing of muscle contractions. If the device goes into safety mode, the device cannot be reprogrammed and must be replaced.

According to FDA, the use of affected product may cause serious adverse health consequences, including early device replacement, loss of pacing or ability to regulate heart rate with serious or life threatening injury (for example, need of temporary pacing where a healthcare provider delivers controlled electric pulses to pace a heart), worsening of heart failure and death.

Boston Scientific’s Q1 2021 Results: CRM up 7.4%, Neuromodulation up 3.5%

Posted on by Posted in AIMD Business, Boston Scientific

Boston Scientific Logo

Boston Scientific announced today its Q1 2021 results, showing CRM up 7.4% from $437M last year to $467M.  Neuromodulation also increased 3.5% from $191M last year to $198M.

Among its accomplishments related to AIMDs, it listed:

  • Launched Vercise Genus™ Deep Brain Stimulation (DBS) System in the U.S. Additionally, the system is being used with the world’s first 16-channel directional leads—Cartesia™ X and HX leads—in the eXTend 3D Study in Europe.
  • Commenced U.S. launch of the WaveWriter Alpha™ portfolio of spinal cord stimulator (SCS) systems, consisting of four full-body MR conditional, Bluetooth-enabled devices, new FAST paresthesia-free therapy and all supported by Cognita™ Solutions—a suite of digital tools that helps physicians and patients navigate the pain management journey.
  • Presented five-year outcomes from the EFFORTLESS study, the largest post-market registry of the Subcutaneous Implantable Defibrillator (S-ICD) System, further validating the long-term efficacy of the device. Results demonstrated 98% overall efficacy over five years, consistent with results of previous S-ICD studies and comparable to or higher than many large transvenous ICD studies.

Boston Scientific Receives FDA Approval for the Vercise Genus™ DBS System

Posted on by Posted in Boston Scientific, Brain Stimulation, Parkinson's Disease

Image Credit: Boston Scientific

Boston Scientific Corporation received U.S. Food and Drug Administration (FDA) approval of its fourth-generation Vercise Genus™ Deep Brain Stimulation (DBS) System. According to the announcement, The portfolio consists of a family of Bluetooth-enabled, rechargeable and non-rechargeable, MR-conditional, implantable pulse generators (IPGs) that power Cartesia™ Directional Leads.

 

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.”

Continue reading→

Boston Scientific’s EMBLEM™ S-ICD System Suggested as First-Line Therapy for ICD Patients without Pacing Indications

Posted on by Posted in Boston Scientific, Cardioversion/Defibrillation, Tachycardia

Boston Scientific presented the final results from the UNTOUCHED study of the EMBLEM™ Subcutaneous Implantable Defibrillator (S-ICD) System presented at HRS 2020 SCIENCE.

The global, prospective, non-randomized UNTOUCHED study evaluated the safety and efficacy of the EMBLEM S-ICD System for primary prevention of SCD, specifically in patients with a LVEF ≤35%.

Data demonstrated S-ICD therapy had an inappropriate shock-free rate of 95.9% at 18-months post-procedure, meeting the primary endpoint with a rate comparable to or lower than those seen in previous S-ICD and transvenous implantable cardioverter-defibrillator (TV-ICD) studies, conclusively showing high efficacy and safety of the EMBLEM S-ICD for patients without pacing indications.

Results for the investigator-sponsored, prospective, randomized, head-to-head PRAETORIAN trial using the EMBLEM S-ICD were also presented, indicating that the S-ICD can be the preferred therapy choice for the majority of ICD-indicated patients without a need for pacing as it offers comparable performance while avoiding lead-related complications and serious infections associated with TV-ICDs.

 

Boston Scientific Q4 and FY2019 Results: CRM Down, Neuromodulation Up

Posted on by Posted in AIMD Business, Boston Scientific

Boston Scientific Logo

On February 5 Boston Scientific announced results for the fourth quarter and full year 2019.  For implantable devices, the relevant numbers are:

Q4:

  • Cardiac Rhythm Management $473M in Q4 2019 vs $488M in Q4 2018, or a reported drop of 3.3%
  • Neuromodulation $261M in n Q4 2019 vs $220M in Q4 2018, or a reported increase of 18.7%

FY 2019:

  • Cardiac Rhythm Management $1,939M in 2019 vs $1,951M in 2018, or a reported drop of 0.6%
  • Neuromodulation $873M in 2019 vs $779M in 2018, or a reported increase of 12.0%

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 .”

FDA Approves Boston Scientific’s ImageReady™ MRI For Vercise Gevia™ DBS

Posted on by Posted in Boston Scientific, Brain Stimulation, MRI-safe, Parkinson's Disease

 

Image Credit: Boston Scientific

Boston Scientific announced the U.S. Food and Drug Administration (FDA) approval of its ImageReady™ MRI labeling for the Vercise Gevia™  Deep Brain Stimulation (DBS) System to be used in a full-body MRI (1.5 Tesla MRI conditional when all conditions of use are met).  This system, with the Vercise Cartesia™ Directional Lead, is designed to treat the symptoms of Parkinson’s Disease (PD) by delivering precisely targeted electrical stimulation in the brain to provide optimal symptom relief and better control of unwanted side effects.

 

Boston Scientific Reports Weak CRM and Neuromodulation Growth

Posted on by Posted in AIMD Business, Boston Scientific, Cardiac Pacing, Cardioversion/Defibrillation, Neural Stimulation

Boston Scientific Logo

Boston Scientific’s Q2 2019 results are out, and they show very weak growth for Cardiac Rhythm Management.

According to the announcement, Q2 2019 CRM sales were $498M, compared to $494M for the same period last year, which constitutes a 0.6% increase on reported basis.

Neuromodulation grew from $202M last year to $204M, or 1.0% on reported basis.