How Abbott designed the world’s first dual-chamber leadless pacemaker system

Abbot’s Aveir DR (left) and VR (right) leadless pacemakers communicate wirelessly with each other from different chambers of the heart. [Image courtesy of Abbott]

The lead engineer on Abbott’s Aveir project explains how his team developed a first-of-its-kind wireless pacemaker system that communicates through blood.

When Abbott’s Aveir DR pacemaker system became the first approved by the FDA for dual-chamber pacing this year, it expanded the benefits of leadless pacing to the majority of patients who need stimulation of both the atrium and ventricle chambers.

The lead engineer on the Aveir project, Matthew Fishler, was working on leadless pacemaker technology at Nanostim when it was acquired by St. Jude Medical in 2013. (Abbott then purchased St. Jude in 2017.) He traced the idea for a dual-chamber leadless system in an effort to eliminate lead failures and other complications of tradition…

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ProMed Molded Products opens new development and innovation facility

NEWS RELEASE: ProMed Molded Products opens new development and innovation facility

ProMed Molded Products, a contract manufacturer supporting applications in medical devices, drug-releasing combination devices, as well as specialized applications arenas for aerospace and defense and automotive, announces the opening of our new development facility in Plymouth, Minnesota. Located less than a mile from our main operations facility, this new 28,000 ft ² building was designed to support new development and innovation by combining R&D, prototyping, product development and tooling under a single roof.

The genesis behind the new facility was to “foster cross-functional collaboration to reduce customer project development timelines and ensure a higher quality product,” said ProMed Engineering Manager Zach Brintz, who was central to the design and execution of the project plans.

Housing approximately 40 engineers and support staff, the new facility’s services and ca…

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Device design and development tips for the future of stroke care

Michael Gilvarry is the GM of Cerenovus in Galway, Ireland. [Photo courtesy of Johnson & Johnson MedTech]

Simplicity and speed will be the most important innovations for medical devices that treat strokes in the years ahead.

That’s according to Michael Gilvarry, GM of Johnson & Johnson MedTech’s Cerenovus business. While he declined to divulge his neurovascular unit’s plans for future products, he offered advice for other device developers in a field where every minute counts.

A large vessel ischemic stroke can destroy more than 2 million brain neurons per minute before treatment restores oxygenated blood flow. A study quantifying the “time is brain” stroke mantra found that hourly neuron loss is equivalent to more than three years of normal aging.

“The drive for simplicity in stroke is very, very strong,” Gilvarry said in a Medical Design & Ou…

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Medical Design & Outsourcing wins TABPI honors for B2B journalism

Medical Design & Outsourcing today won two Tabbie Awards for business-to-business journalism from Trade, Association and Business Publications International (TABPI).

The publishing organization named Medical Design & Outsourcing‘s March 2022 edition as one of the top 25 issues in the category of best single issue. TABPI described that category as “the competition’s most comprehensive.”

Award winners for the March 2022 edition — which focused on medical device miniaturization — were Managing Editor Jim Hammerand, Senior Art Director Matthew Claney, Senior Editor Danielle Kirsh, Pharma Editor Brian Buntz and Associate Editor Sean Whooley.

Medical Design & Outsourcing’s also won an honorable mention in the category of best special section for our September 2022 Medtech Big 100 project. Award winners were Executive Editor Chris Newmarker, Hammerand, Kirsh, Whooley and Buntz.

“The data gathering for the Big 100…

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Phillips-Medisize and Modular Medical partner on insulin delivery alternatives

Phillips-Medisize designed and developed manufacturing and assembly for Modular’s MODD1 insulin delivery system. [Image courtesy of Modular Medical]

NEWS RELEASE: Modular Medical Partners with Phillips-Medisize to Expand Insulin Delivery Alternatives Modular Medical, Inc. (Nasdaq:MODD), a development stage insulin delivery technology company seeking to launch the next generation of user-friendly and affordable insulin pump technology, today announced a collaboration under which Phillips-Medisize, a Molex company and a leader in the design, engineering and manufacturing of pharmaceutical drug delivery, invitro diagnostic, medtech and specialty consumer devices, is providing Modular Medical with design, development and high-volume manufacturing capabilities.

Phillips-Medisize leveraged its global, diversified supplier base and deep medical device and diabetes disease experience to desi…

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MassMEDIC announces 2023 MedTech Ignite accelerator cohort

The Massachusetts Medical Device Industry Council (MassMEDIC) today announced the 2023 cohort for its MedTech Ignite Program.

MassMEDIC’s accelerator for medtech entrepreneurs features hybrid workshops, boot camps, conferences, networking opportunities and mentorships. The intensive three-month program runs from September to November 2023.

The regional medtech association selected eight companies developing medical device, diagnostic and digital health technologies for its cohort:

Aim Medical Robotics The company develops a portable, MRI-compatible surgical robot for use in the MRI suite and operating room. It aims to bring high levels of precision, automation and efficiency to neurosurgery. Brainbot According to MassMEDIC, the company developed the first gamified concussion recovery app. It facilitates rehabilitation through health optimization and at-home self-management. Craniosense The company aims to change the trajectory of care for trau…
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The 10 largest orthopedic device companies in the world

The goal of Stryker’s Mako robotic-arm assisted surgery is to provide more predictable outcomes. [Image courtesy of Stryker]

Two of the world’s largest orthopedic device companies expect accelerated revenue growth this year.

Stryker and Zimmer Biomet both upped their 2023 guidance during recent earnings calls, a sign that orthopedic procedures are bouncing back from the COVID-19 pandemic.

GlobalData predicted earlier this year that the recovery will lift the ortho devices market to nearly $50 billion this year. The question is whether companies can continue the momentum. Stryker and ZB are betting on innovation, building arrays of products and services around their surgical robotics systems and surgical planning and digital health tools.

During Zimmer Biomet’s second-quarter earnings call, CEO Bryan Hanson noted that ZB has 40 planned product launches between this year and the end of 2025, the …

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Shunt device startup wants to break barriers in nitinol and heart sensing

Adona Medical is designing its adjustable heart shunt device with pressure sensors on both sides of the heart. [Illustration courtesy of Adona Medical]

Medical devices have yet to tap nitinol’s shape memory properties, but that’s just one breakthrough Adona Medical hopes to achieve with its adjustable, bi-atrial-sensing heart shunt.

Adona Medical co-founder and CEO Brian Fahey’s presentation on his shunt device startup’s aspirations elicited palpable interest from the cardiologists in the room at CSI Frankfurt.

“You plan to disrupt two fields in heart failure?” asked Dr. Daniel Burkhoff, the director of heart failure, hemodynamics and MCS research at the Cardiovascular Research Foundation’s Clinical Trials Center.

“We’re going to try,” Fahey replied. “Our plan is to improve patient care.”

Fahey has publicly said little abo…

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Pay drops for Medtronic CEO and the median employee; bonus plan changes

Medtronic disclosed total compensation for its top executives as well as its median worker while revealing changes to the way Medtronic Incentive Plan bonuses will be calculated.

Medtronic (NYSE:MDT) paid Chair and CEO Geoff Martha $15.4 million in fiscal 2023, the world’s largest medical device company said in its annual disclosure of pay for top executives.

That’s a 14% decrease from the year before, primarily due to Martha receiving nothing this year under the Medtronic Incentive Plan (MIP).

Pay also dropped 14% to $67,073 for Medtronic’s median worker, which the company is required to identify for comparison to CEO pay. That CEO pay ratio increased from 215:1 to 230:1 in fiscal 2023 (ended April 28, 2023).

Dublin, Ireland-based Medtronic used the same individual employee as its median worker as it did last year, saying there was “no change in our employee population or employee compensation arrangements since that median was i…

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Boston Scientific’s Farapulse PFA system is poised for FDA approval, analysts say

The Farapulse system’s Farawave single-shot ablation catheter expands inside the patient to deliver energy for treating AFib. [Image courtesy of Boston Scientific]

Boston Scientific’s Farapulse pulsed-field ablation (PFA) system likely hit its primary endpoints, according to Needham analysts who say that means the technology is poised for FDA approval.

Boston Scientific has already said it expects FDA approval of Farapulse next year, but has not yet shared results from its ADVENT pivotal trial.

That data is set for release on Aug. 27 at the 2023 European Society of Cardiology (ESC) Congress. The device developer started that trial in March 2021 and stopped enrolling patients in June 2022.

Based on the trial’s adaptive design with a varying number of possible patients — 350, 450, 550, 650 or 750 — and the timing of enrollment, the Needham analysts say they suspect Boston Scientifi…

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Trelleborg launches BioPharmaPro product line

NEWS RELEASE: Trelleborg launches BioPharmaPro range

Trelleborg Healthcare & Medical’s BioPharmaPro range supports customers with products including fully assembled chromatography equipment with advanced composite columns. [Image courtesy of Trelleborg]

Trelleborg Healthcare and Medical launches the BioPharmaPro family of innovative products, materials and services for fluid path single-use equipment to accelerate the advancement of life-changing therapies.

Building on its history of innovation, Trelleborg Healthcare & Medical’s BioPharmaPro range delivers solutions created from a vast portfolio of materials, including silicones, other elastomers, thermoplastics, and composites, which can be manufactured into tubing, custom molded components, processing columns, up to full assemblies, and much more.

Solutions range from individual single-use components to complex assemblies and full biopharmaceut…

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Promex promotes recent hire to chief operating officer

Promex Industries Chief Operations Officer David Fromm [Photo courtesy of Promex]

Promex today said it has promoted VP of Engineering David Fromm to chief operating officer.

The Santa Clara, California-based subsystems supplier hired Fromm in March. Promex said Fromm will also remain VP of engineering and lead the operations, engineering, and business development teams.

“Dave has walked in the shoes of OEM engineers, project leads, and procurement decision-makers. He is uniquely qualified to bring a customer-focused perspective to every aspect of the Promex business,” Promex CEO Richard Otte said in a news release. “He understands how to partner for turnkey, vertically integrated approaches to creating the smallest, most complex medical devices that are enabled with microelectronics.”

Before joining Promex, Fromm worked with the company as a customer for nearly 10 years. He was previously director…

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