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

Monthly Archives: February 2020

Concerns over SweynTooth BLE Vulnerability Potentially Affecting Medical Devices

Posted on by Posted in Cybersecurity

Pacemaker cybersecurity

Researchers recently uncovered a suite of vulnerabilities (SweynTooth) related to the Bluetooth Low Energy (BLE) protocol that could impact medical devices that contain the affected SDKs of system-on-a-chip (SoC) BLE modules.

According to the researchers at the Singapore University of Technology and Design, SweynTooth captures a family of 12 vulnerabilities (more under non-disclosure) across different BLE software development kits (SDKs) of seven major system-on-a-chip (SoC) vendors. The vulnerabilities expose flaws in specific BLE SoC implementations that allow an attacker in radio range to trigger deadlocks, crashes and buffer overflows or completely bypass security.

SweynTooth vulnerabilities have been found in the BLE SDKs sold by major SoC vendors, such as Texas Instruments, NXP, Cypress, Dialog Semiconductors, Microchip, STMicroelectronics, Telink Semiconductor, and others.  It is still unknown if any of these vulnerabilities affect any medical devices (including the newest implantable devices that have direct BLE connectivity with a patient’s cellphone).

 

 

US EPA’s Assessment of Ethylene Oxide Affects Implantables Industry

Posted on by Posted in AIMD Business, Sterilization

Ethylene Oxide Sterilization of Active Implantable Medical Devices www.implantable-device.com David Prutchi PhD

Ethylene oxide (EtO) is a chemical that is used to sterilize more than 50% of all medical device types and is crucial for preventing infection in patients undergoing surgeries and other medical treatments. For active implantable medical devices, EtO is pretty much the only option for sterilization. Alternative methods such as steam, radiation, or other sterilants either damage the device or do not achieve the needed levels of sterility assurance.

The US Environmental Protection Agency has been waging a war against the use of EtO by establishing an unreasonably low value for EtO concentration in its Integrated Risk Information System (IRIS).  AdvaMed (the Advanced Medical Device Association) has urged the EPA to reassess its EtO value for one that is more feasible, based on the best available science and that will not potentially endanger the public health by threatening the availability of needed medical technologies.

AdvaMed President and CEO Scott Whitaker stated:

“… EPA’s EtO risk assessment standard is unworkable and not based on the best available science. The agency’s failure to address these valid scientific concerns surrounding their value threatens not only the medical technology supply chain but the tens of millions of American patients that rely on EtO-sterilized devices. We ask the agency to follow its own scientific recommendations and develop a revised EtO risk assessment standard that will effectively protect the public health and not disrupt patient access to needed medical technology.”

Click here to read AdvaMed’s complete response to the EPA.

 

 

 

 

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%

SCS Companies Developing “Low Dose” Recharge-Free Spinal Cord Stimulation Devices

Posted on by Posted in Abbott, Pain, Spinal Cord Stimulation

Image Credit: Abbott

Spinal Cord Stimulation uses quite a bit of power, which is why SCS IPGs have either been rechargeable, or operated from a primary cell, but compromised on longevity.

Because recharging is sometimes perceived by patients as a hassle, SCS companies have been developing and testing “low-dose” stimulation regimens with the intention of yielding high-longevity SCS IPGs that don’t require recharging.

In September 2019 FDA approved Abbott’s Proclaim™ XR neurostimulation system which uses Abbott’s proprietary, low energy BurstDR™ therapy coupled with the BoldXR™ low dosing protocol for safe, effective pain relief and a battery that lasts up to 10 Years (at low-dose settings).

Approval was based on the results of the “BurstDR micrOdosing stimuLation in De-novo” patients (BOLD) study, which showed 100% of 24 enrolled patients on a low-energy BurstDR dosing program experienced pain relief with less than six hours of battery use per day, while approximately 50% of those patients achieved pain relief with the lowest effective dose (less than two hours of battery use per day). Even at the highest settings, the systems were still in use only 25% of the time.

 

SCS Company Nuvectra Filed for Bankruptcy

Posted on by Posted in CCC Medical, Greatbatch, Integer, Nevro, Nuvectra, Pain, 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.

James Cavuoto, Editor and Publisher of Neurotech Reports, wrote about possible reasons for Nuvectra’s failure:

“… Some critics of Nuvectra have cited management problems and quality control issues with its Algovita device as factors leading to the filing. Fred Parks, a medical device industry veteran with little experience in the SCS market, took over for founding CEO Scott Drees in January. Others have pointed to problems managing the company’s suppliers and an overly burdensome agreement Greatbatch required as part of the spinoff. …” [2019]