Medtronic launches penditure stroke clip in Europe after CE Mark approval for aFib surgery

USA—Medtronic has received CE Mark approval in Europe for its Penditure surgical implant, designed to close the heart’s left atrial appendage.

This procedure aims to lower the long-term risk of stroke in patients with irregular heart rhythms, such as atrial fibrillation (afib).

The left atrial appendage is a small pouch in the heart where blood clots can form, thereby increasing the risk of stroke.

Closing this pouch during heart surgery can help prevent these dangerous clots.

The FDA approved the Penditure system in late 2023, and Medtronic has since delivered over 10,000 of these implants worldwide.

These clips are typically placed during open-heart surgery performed for other reasons.

The implant comes pre-loaded in a single-use delivery system, allowing surgeons to reposition or recapture the clip if necessary.

Medtronic acquired the Penditure system from medical device incubator Syntheon in 2023.

Clinical guidelines recommend that patients with afib who are undergoing other heart surgeries should have their left atrial appendage closed.

This can be done either with specialized implants like Penditure or by surgically removing or suturing the pouch.

Closing this appendage reduces stroke risk by preventing clot formation in this high-risk area.

Several major medical technology companies are developing devices to close the left atrial appendage.

This is driven by the rising number of afib diagnoses, which are increasing as the population ages.

Market analysts predict that the global market for these devices will reach nearly US$6 billion by 2030.

Currently, Boston Scientific and Abbott dominate the market with their catheter-based implants, the Watchman and Amplatzer Amulet, respectively.

 These devices expand inside the pouch to seal it and block blood flow.

For open surgeries, AtriCure offers the AtriClip Pro series, including the smaller AtriClip Pro-Mini, which received FDA clearance earlier this year and has begun limited deployment.

Around the same time Medtronic announced the Penditure acquisition, Johnson & Johnson MedTech acquired Laminar for US$400 million.

Laminar’s device uses a minimally invasive technique that twists inside the pouch to close it by gathering tissue.

J&J started enrolling patients in a pivotal trial for this device in 2024.

Boston Scientific is also preparing to update its Watchman device.

Following FDA approval in 2023, the company plans to conduct a clinical trial in 2026, with a market launch anticipated in late 2027 or early 2028.

Additionally, Boston Scientific is collaborating to integrate the Watchman with its Farapulse pulsed field ablation technology, which is used to treat atrial fibrillation (AFib).

This combined approach aims to reduce stroke risk through a single integrated procedure.

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