J&J’s Acclarent wins FDA nod for pediatric ear tube balloon dilation system

The Aera system. [Image from J&J/Acclarent]Johnson & Johnson MedTech unit Acclarent announced that it won a new FDA clearance for its Aera Eustachian tube balloon dilation system.

While Acclarent still belongs to Johnson & Johnson, Integra Lifesciences is set to buy it for $275 million next year. While the completion of that deal awaits, the company cleared a regulatory hurdle that expands the patient population for its Aera system.

The new FDA clearance expands access to children aged eight to 17 with persistent obstructive Eustachian tube dysfunction (OETD). Previously only indicated for adults, the system can now treat pediatric patients, making Acclarent the first and only company to achieve a pediatric indication for a Eustachian tube balloon dilation system, according to a news release.

Until now, according to Acclarent, children with persistent OETD only had a handful of options. Those included tympanostomy (ear) tubes, adenoidectomy (rem…

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Integra LifeSciences to buy Johnson & Johnson’s Acclarent and its ENT tech

Integra LifeSciences (Nasdaq: IART) + announced today that it entered into a definitive agreement to acquire Acclarent from Johnson & Johnson MedTech.

Acclarent, part of J&J MedTech’s Ethicon unit, enhances Integra’s position in the ear, nose and throat (ENT) treatment market. Integra already offers the MicroFrance line of ENT instruments. The company believes that, upon closing, the deal propels it into a position as a leading provider of ENT products and technologies.

Integra agreed to acquire Acclarent for $275 million in cash at closing. The deal also includes an additional $5 million upon the achievement of regulatory milestones.

“This acquisition presents Integra with a rare opportunity to become a key player in the ENT segment. Acclarent’s culture of pioneering technologies aligns with Integra’s legacy of innovation to transform care and restore patients’ lives,” said Jan De Witte, pre…

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J&J’s Acclarent wins FDA clearance for navigated shaver blade for ENT procedures

Johnson & Johnson MedTech’s Acclarent business announced FDA 510(k) clearance for its TruDi shaver blade and its advanced navigation features.

In a news release posted yesterday, Acclarent described TruDI as a single-use electromagnetically navigated blade. It’s used with the company’s Bien-Air S120 shaver for the incision and removal of soft and hard tissue or bone in ENT, maxillofacial surgery, head and neck, and ENT skull base surgery.

The TruDi shaver blade is navigable. It has distal tip sensor integration, enabling the display of the blade’s position and opening on the TruDi navigation system.

“When performing endoscopic sinus procedures, every millimeter counts, so a navigable shaver blade connected to a sophisticated mapping system that provides real-time visualization of the blade location helps me know where I am, where my trainees are, and where we are going during surgery,” said Dr. C.S. Ebert Jr. professor at the Depart…

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DTW Podcast: How Josh Makower wrote the book(s) on medtech innovation

Josh Makower, MD, quite possibly invented modern day medtech innovation.

In this interview, Makower shares his earliest inventions – kind of mind-blowing – and how his early work at Pfizer helped him create the innovation process used today by biodesign programs across the world, including Stanford Biodesign where Dr. Makower will take over as director this fall.

This interview is essential for any individual or organization that wants to innovate. Dr. Makower will share his thoughts on how innovation in any industry should be approached.

This week we’ll explore innovation and social equity. We’ll hear a portion of an interview with Martha Ha, chief privacy officer and chief counsel of corporate governance, and Jon de Csepel, CMO, vice president, medical affairs of the Americas. The pair will explain how the company is reaching out to employees of Asia and Pacific Island and helping them to understand how to better work within the corporate culture. The …

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Ex-Acclarent execs fined $1.5M in off-label marketing case

[Image from Unsplash]There will be no prison time for the two former Acclarent executives convicted of federal misdemeanor charges related to marketing a sinus balloon catheter for unapproved uses.

Former Acclarent CEO William Facteau will instead pay a $1 million fine, and the company’s ex-sales VP Patrick Fabian will pay $500,000, according to the sentence handed down yesterday by U.S. District Judge Allison Burroughs in Massachusetts.

The case goes back a decade and involves accusations that Facteau and Fabian improperly marketed the device leading up to Johnson & Johnson’s $785 million acquisition of the company in 2010.

Burroughs apologized to the two men that it took more than four years after their convictions for them to receive a sentence —  also saying that the fines were enough punishment for their “crime of greed,” according to a report from Reuters.

Facteau has been CEO of hearing tech company Earlens since 20…

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