November 2023 Medical Device Handbook: Breaking new ground in medtech



 

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

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Moon Surgical thinks Maestro’s light touch can win the surgical robotics arms race

Breaking new ground in medtech

This year has brought a flurry of firsts from medical device manufacturers as they develop new and improved products despite continued supply chain and economic challenges.

These device innovations have been in the works for years, pushed forward by teams ranging from small startups to the world’s largest medtech companies — and all with help from outsourcing partners.

All of these industry players have come together once again in our latest edition of the Medical Design & Outsourcing Medical Device Handbook to offer uniquely relevant and actionable advice for device designers and engineers.

This edit…

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Inari Medical closes LimFlow acquisition

The LimFlow System. [Illustration courtesy of LimFlow]Inari Medical (Nasdaq: NARI) + announced that it completed its acquisition of chronic limb-threatening ischemia (CLTI) treatment maker LimFlow.

The Irvine, California–based company earlier this month announced plans to acquire LimFlow for up to $415 million. The deal came just weeks after Paris-based LimFlow won FDA premarket approval (PMA) for its breakthrough CLTI treatment. Inari Medical intends to pay a total upfront consideration of $250 million in cash at closing.

Contingent consideration of up to $165 million in additional cash payments hinges on certain commercial and reimbursement milestones. Inari expects to pay those tranches out between 2025 and 2027. The company said it funded the acquisition at close from existing cash resources.

LimFlow designed its system for transcatheter arterialization of deep veins. It diverts blood from a diseased tibial art…

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Inari Medical plans manufacturing operations in Costa Rica

Inari Medical executives attended a ceremony in Costa Rica announcing the new manufacturing site. [Photo courtesy of CODE Development Group]

Inari Medical plans to have up to 600 employees at a manufacturing facility in Costa Rica’s Evolution Free Zone, the high-tech business park said.

The medical device developer will initially invest $15 million for a building totaling more than 7,000 m² in Tacares de Grecia, Evolution Free Zone said in a news release.

Inari Medical will have more than 300 employees in the first phase and plans to double that in the second phase.

“The rapid market uptake of our specially designed tools for treating patients with venous thromboembolism (VTE) and other vascular diseases led us to make the decision to build a high-volume manufacturing facility, which will help us meet this growing global demand,” Inari Medical Operations SVP Paul Koehn said in th…

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Inari Medical plans to buy LimFlow Medical for up to $415M

The LimFlow System for Transcatheter Arterialization of Deep Veins diverts blood from a diseased tibial artery to a tibial vein to deliver oxygen to a patient’s ischemic foot. [Illustration courtesy of LimFlow]Inari Medical (NASDAQ: NARI) + today announced a definitive agreement to purchase LimFlow Medical for up to $415 million.

The deal comes just weeks after Paris-based LimFlow won FDA premarket approval (PMA) for its breakthrough system to treat chronic limb-threatening ischemia (CLTI).

San Jose, California–based Inari said it expects to complete the acquisition by the end of 2023. Inari will pay $250 million in cash at closing, plus up to $165 million based on certain commercial and reimbursement milestones.

Medical Design & Outsourcing: How LimFlow’s foot-saving system prevents amputations in patients with no other options

Inari CEO Drew Hykes said the LimFlow acquisition “is closely aligned …

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