Category Archives: Uncategorized

Image Credit: Atacor

 AtaCor Medical, Inc., a privately-held medical device company, announced the enrollment of the first patient in the ALARION-EV study to evaluate its Atala™ parasternal extravascular lead with an Abbott implantable cardioverter-defibrillator (EV-ICD).

The Atala™ lead is implanted through a small left parasternal incision, with the lead positioned through a rib space and electrodes placed against the pericardium.  The lead allows the IPG to be placed in either a lateral or pectoral device pocket.

The ALARION-EV trial is a prospective, multi-center, single-arm study that will enroll up to 280 patients in up to 40 sites in the US and the Netherlands, aiming to demonstrate the safety and effectiveness of the Abbott investigational parasternal EV-ICD System through at least six months of follow-up to support a PMA.

The historical device display at HRS received a wonderful reception, and I am grateful to everyone who stopped by to look, ask questions, and share memories.

Together with Dr. James Ong, Dr. Jason Jacobs, and Dr. Aileen Ferrick, I had the privilege of curating a display centered on the evolution of power sources used for cardiac pacing. The exhibit traced the story from Albert Hyman’s crank-driven pacemaker, Paul Zoll’s mains-powered externals, Earl Bakken’s battery-powered wearable pacemaker, through the NiCd-powered implantable pacemakers of the late 1950s and 1960s, to the first lithium-powered pacemakers of the mid-1970s. We also included the always crowd-pleasing nuclear-powered pacemakers, along with the lesser-known but fascinating RF-powered pacemakers and Pacesetter rechargeable devices.

The response from attendees was deeply gratifying. These devices are more than technological artifacts; they represent decades of clinical need, engineering creativity, patient courage, and relentless innovation in cardiac rhythm management.

I would like to thank Germaine Schaefer, HRS Vice President of Meetings and Events, for organizing such a magnificent conference, and to thank my colleagues for the hard work we put into cleaning up the vast HRS collection and curating this display.

It was a pleasure to help bring this important history to life at HRS.

I’m excited to announce that I’ve been invited to deliver a keynote at the 2026 AIMD Workshop to be held at the University of Delft!

From the announcement:

“We’re excited to announce David Prutchi, Ph.D. participation as a speaker at the AIMD Workshop 2026!

His keynote, “How Early Pacemakers Shaped Modern AIMDs” will explore the origins of implantable cardiac pacing through an engineering lens, drawing on his recently published paper “Pioneering Rhythm Management: A Design Analysis of the Earliest Battery-Powered Implantable Pacemakers” (co-authored with Daniel Villamil). The talk will revisit the first pacemakers developed by Elmqvist and Greatbatch, highlighting their convergent design choices, early power-source strategies, and the elegant simplicity that shaped modern implantable therapies.

David is CTO and Executive VP at Impulse Dynamics and brings over 30 years of MedTech industry experience. A leader in active implantable medical device development, he has guided technologies from early R&D through regulatory approval, clinical trials, and commercialization. He is also the author of several industry-defining books, with more than 40 scientific publications and over 80 patents to his name.

For more information and registration visit https://lnkd.in/deYwYuHy

Event co-organized by ADCORPUS & Delft University of Technology (Nicolas Barabino, Wouter Serdijn, Francesc Varkevisser)”

There is currently a shortage of ventilators to help patients with severe respiratory distress due to COVID-19.

Many DIY designs are thus popping up on the Internet showing how mechanisms to pump a bag valve mask (BVM, AKA by the proprietary name “Ambu bag”) could be used as a makeshift ventilator.

Unfortunately, these can do a lot more harm than good.  I would like to point anyone thinking about constructing such mechanism to first watch the following video:

In the US, even under these emergency circumstances, these quickly-built “Ventilators for Emergency Mass Use” (VEMU) or “Emergency Use Ventilators” (EUV) MUST receive authorization by FDA before they can be used to ventilate patients.

FDA has issued an Emergency Use Authorization (“EUA”) that allows certain ventilators – as well as anesthesia gas machines modified for use as ventilators, positive pressure breathing devices modified for use as ventilators, ventilator tubing connectors and ventilator accessories – to be distributed in the U.S., notwithstanding the fact that the devices have not obtained the FDA marketing authorizations that would otherwise be required prior to marketing the products.

To be authorized under the EUA, a device must meet certain requirements, and must be added by FDA to a list of authorized products .  Detailed information about the EUA, including regarding the criteria that must be satisfied for a product to be authorized was issued by FDA on March 24, 2020 and is available here.

In this letter you will see that the requirements are not simple at all, and that the vast majority of DIY designs that simply pump an ambu bag don’t even start to scratch the surface of what would be needed to fulfill even the most basic requirements for safety and performance set by FDA under this emergency.

AAMI published a DRAFT Emergency Use Ventilator (EUV) Design Guidance which describes the minimum requirements of ISO 80601-2-80 that must be fulfilled by an EUV.

If you are considering the design of a VEMU, please start by learning about the requirements for safety and performance rather than by building yet another contraption that can do much more harm than good in this emergency.

Image Credit: Abbott

Abbott announced that it received FDA’s approval for the treatment  of Parkinson’s, Essential Tremor, and some other movement disorders by stimulating the Internal Globus Pallidus (GPi) with its Infinity™ Deep Brain Stimulation (DBS) system.

This is the first approval by FDA using the Internal Globus Pallidus (GPi) as an alternative target to the subthalamic nucleus (STN) and ventral intermediate nucleus (VIM) for the treatment of these movement disorders.

Image Credit: Medtronic

Back in November 2019 Medtronic announced results from the MARVEL 2 (Micra Atrial Tracking Using A Ventricular accELerometer) study showing that an investigational set of algorithms in the Micra™ leadless pacemaker improves synchrony and cardiac function in patients with  atrioventricular (AV) block.  At the time, Medtronic submitted to FDA for approval of the Micra AV pacemaker, to expand the indicated population to AV block and normal sinus rhythm.

Medtronic announced this week that it received FDA’s approval for its Micra AV™ leadless pacemaker to treat AV block.

According to this week’s announcement:

“Micra AV is unique in the history of pacemakers. Until now, pacemakers sensed the heart’s electrical signals and used that information to provide pacing. But Medtronic scientists figured out how to re-purpose sensors, already inside the original Micra pacemaker, to recognize certain physical, or mechanical movements, within the heart – an approach to pacing that’s never been done before. Micra AV can detect the mechanical movement of a beat in one chamber of the heart – the atrium – and then pace another chamber where Micra is implanted – the ventricle – so the atrium and ventricle beat in synchrony.”

Not new, but recently came across while researching some information about related devices…

The NASA Tech Briefs of May 1999 described a device that telemeters pressure changes to detect intrauterine contractions.  According to the brief:

A biotelemetric system for monitoring key physiological parameters of a fetus and its uterine environment is undergoing development. The main purpose of the monitoring is to detect preterm labor in order to enable timely treatment. At the present stage of development, the system monitors pressure changes and temperature. The pressure changes serve as direct indications of intrauterine contractions that could be associated with the onset of preterm labor. Future versions of the system are expected to monitor additional parameters, including pH and the heart rate of the fetus.

Transient Electronics Dissolves in Water

A collaboration of Tufts Univeristy, University of Illinois and the Defense Advanced Research Projects Agency (DARPA) resulted in the development of electronic devices that dissolve in water or biological fluids dissolves and break down in traces of silicon and magnesium. Because of the small amount, these components can be harmlessly assimilated by biosystems like the human body, potentially opening the path to the development of implantable electronic devices that require only temporary implant, but instead of being surgically explanted, are simply allowed to get absorbed by the body after their mission is over.

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Image Source: IOP Science

Scientists at Wake Forest University School of Medicine in Winston-Salem, North Carolina reported using a neural implant to stimulate higher-level thinking in monkeys, providing the first demonstration in primates of the sort of brain prosthesis that could eventually help people with damage from dementia, strokes or other brain injuries.  The study was published on Sept. 14 in IOP Publishing’s Journal of Neural Engineering.

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Image Credit: Boston Scientific

Boston Scientific announced today that FDA has approved revised product labeling for  its INCEPTA™, ENERGEN™, PUNCTUA™, COGNIS® and TELIGEN® ICDs and CRT-Ds to reflect increased longevity projections for these devices.  The longevity projections are based on data submitted to the FDA and vary for each device dependent on the model type and settings.

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Reported by dotMedNews.com: 

FCC could open spectrum to wireless body sensors

Image Credit: St. Jude Medical

St. Jude today announced FDA approval of its Ellipse™ ICD.  The device’s shape was designed with feedback from more than 200 physicians from around the world.  The Ellipse ICD offers physicians unique design advancements, resulting in a high-energy ICD that occupies barely 30cc.

According to the announcement, “The Ellipse ICD’s unique shape was conceptualized by physicians during focus groups where they crafted in clay their vision for the ideal device design. The physician-inspired shape is unlike any device currently available and designed to increase patient comfort and physician ease-of-use. The angled header and rounded edges were designed to improve the way a lead wraps around the device once connected, which can result in a smaller incision and reduced pocket size for the device.”

Medtronic received FDA approval for the expanded use of CRT-D in mildly-symptomatic heart failure patients.  The expanded indication includes New York Heart Association (NYHA) Class II heart failure patients with a left ventricular ejection fraction (LVEF) of less than or equal to 30 percent, left bundle branch block (LBBB), and a QRS duration greater than or equal to 130 milliseconds. Nearly 200,000 Americans are considered NYHA Class II, with another 620,000 people worldwide fitting this designation.

The FDA’s decision for the expanded indication rests on data from the pivotal REVERSE (REsynchronization reVErses Remodeling in Systolic left vEntricular dysfunction) and landmark RAFT (Resynchronization/Defibrillation in Ambulatory Heart Failure Trial) clinical trials, which showed that CRT-D can benefit mildly symptomatic heart failure patients by reducing mortality and heart failure hospitalization rates.The expanded indication includes New York Heart Association (NYHA) Class II heart failure patients with a left ventricular ejection fraction (LVEF) of less than or equal to 30 percent, left bundle branch block (LBBB), and a QRS duration greater than or equal to 130 milliseconds. Nearly 200,000 Americans are considered NYHA Class II, with another 620,000 people worldwide fitting this designation.

Click here for press release from Medtronic.