Gavin Newsom Archives - Medical Design Sourcing

Medtronic wins CE mark for Affera ablation system

The all-in-one Sphere-9 catheter for mapping and ablation. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that it received CE mark approval for its Affera mapping and ablation system.

The Affera system includes the Sphere-9 catheter and Affera Prism-1 mapping software. Together, the system integrates Sphere-9 pulsed-field ablation (PFA), radiofrequency (RF) and high-density (HD) mapping. It maps and ablates atrial arrhythmias — including AFib — and provides real-time feedback through its mapping and navigation software.

Sphere-9 combines with the mapping and navigation system to generate sophisticated electro-anatomical maps. These allow the physician to deliver wide-area focal ablation lesions of choice between RF or PFA. The catheter features a nitinol 9mm ablation tip that may allow for fewer focal ablation lesion applications. Medtronic said it could result in lower procedure times compared to standard irrigated ablation catheters. The compa…

Medtronic offered early retirements as medtech industry layoffs mount
Employees in supply chain, cybersecurity and other specific roles were excluded from the offer.

Medtronic (NYSE:MDT) offered early retirement incentives in recent weeks as the world’s largest medical device company seeks to cut costs before the end of its fiscal year in April.

The medical device developer and manufacturer has said little about potential job cuts among its ranks, which it reported as more than 95,000 people worldwide at the end of the company’s last fiscal year.

Fridley, Minnesota–based Medtronic has promised “significant expense reductions” in the final quarter of its fiscal year, which ends April 28, 2023. Meanwhile, MassDevice has reported on more than 19,000 medtech workers let go across the industry since mid-2022. (If you have information to share on or off the record, get in touch with me by email or LinkedIn.)

“Medtronic continually evaluates its operations to ensure a competitive business model aimed at long-term growth aligned to the needs of our customers,” the company said in a…

The top 10 cardiac device stories of 2022

[Image from Pixabay]From pulsed-field ablation to non-invasive monitoring, this was an exciting year for cardiac device tech.

Here are the top 10 cardiac device stories from MassDevice and its sister sites:

10. Medtronic to pay Acutus $17M following EU MDR submission of left-heart access portfolio

Earlier this year, Acutus agreed to sell its left-heart access portfolio to Medtronic for $50 million.

9. Abbott confirms first implants of its dual-chamber leadless pacemaker system

The company designed its i2i technology to provide beat-by-beat communication between two leadless pacemakers, with one positioned on the right ventricle and the other in the right atrium.

8. Boston Scientific completes $1.75B Baylis Medical acquisition

The deal expanded Boston Scientific’s electrophysiology and structural heart product portfolios to include the radiofrequency (RF) NRG and VersaCross transseptal platforms. It also gained a family of guidewires, sheaths an…

Medtronic completes enrollment in pulsed-field ablation catheter trial

Medtronic’s Sphere-9 mapping and ablation catheter [Photo courtesy of Medtronic]Medtronic today announced it completed enrollment and final treatment in the Sphere Per-AF pivotal trial to study Affera’s pulsed-field ablation catheter tech.

The trial is evaluating the safety and effectiveness of the Sphere-9. The Sphere-9 is a pulsed field (PF) and radio frequency (RF) ablation and high-density mapping catheter. Along with the Affera cardiac mapping and navigation platform, it treats atrial fibrillation.

Affera designed the technology to diagnose, map and treat heart arrhythmias with ablation. It scars heart tissue to interrupt errant signals using both radiofrequency ablation and non-thermal pulsed-field ablation technology. Medtronic acquired the company for $1 billion in August.

Get the full story on our sister site, Medical Tubing + Extrusion.

Why Affera’s cardiac ablation technology is worth $1B to Medtronic

Affera’s Sphere-9 mapping and ablation catheter [Photo courtesy of Affera]

Affera started in 2014 with a simple goal that paid off when Medtronic (NYSE:MDT) bought the company for up to $1 billion this year.

Achieving that goal, however, took some unconventional and sometimes difficult design choices, Affera founder and CEO Doron Harlev said.

Newton, Massachusetts–based Affera’s system diagnoses, maps and treats heart arrhythmias with ablation. It’s a process that scars heart tissue to interrupt errant signals. Affera’s system uses both radiofrequency (RF) ablation — as well as the non-thermal pulsed-field ablation tech that has been generating buzz in medtech.

Complex arrhythmias like atrial fibrillation and ventricular tachycardia can require an electrophysiologist to perform more extensive ablation. But Harlev and his team at Affera thought a larger ablation tip could ma…

Medtronic completes Affera acquisition

Medtronic (NYSE:MDT) announced today that it completed its acquisition of cardiac mapping and ablation technology developer Affera.

Newton, Massachusetts-based Affera designs and manufactures cardiac mapping and navigation systems, as well as catheter-based cardiac ablation technologies, including a differentiated, focal pulsed-field ablation platform for treating cardiac arrhythmias like AFib.

In January, Medtronic announced an agreement to acquire Affera, with CEO Geoff Martha labeling the deal as a nearly $1 billion transaction at the J.P. Morgan Healthcare Conference, adding that it includes a $250 million contingent consideration.

The company had been a strategic investor in Affera through its minority investment portfolio. Prior to the acquisition, Medtronic held a 3% stake in the company.

According to a news release, the acquisition expands Medtronic’s cardiac ablation portfolio. The portfolio will now include its first-ever cardiac m…

What is the future of cardiac ablation?

Boston Scientific in July 2021 exercised its option to acquire the remaining shares of PFA tech developer Farapulse. [Image courtesy of Boston Scientific]Pulsed-field ablation (PFA) — a non-thermal method for cardiac ablation — has the potential to positively disrupt the atrial fibrillation market.

Amid the excitement around the technology, Medtronic announced in January that it would acquire cardiac mapping and ablation technology developer Affera for nearly $1 billion. Meanwhile, Boston Scientific in February closed its $1.75 billion acquisition of Baylis Medical — the creator of advanced transseptal puncture platforms to enhance safety, efficacy and efficiency when crossing the atrial septum to deliver therapies in the left side of the heart. Months before, Boston Scientific exercised its option to acquire the remaining shares of PFA tech developer Farapulse.

Come to DeviceTalks Boston — May 10-11, 2022 — and hear from leaders at Boston Scientific, Medtronic an…