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FDA clearedFDA cleared. Stage 4 of 4 (Authorized)

Penumbra Launches Link Clot Capture Device for Use With Lightning Bolt Thrombectomy

The device grips organized clot while Penumbra's computer assisted vacuum thrombectomy pulls it into the catheter; the company released one physician's account but no trial data.

By News DeskSeptember 10, 20262 min read
An empty catheterization lab with an X-ray C-arm, patient table and overhead monitors
A catheterization laboratory in Germany. Not a Penumbra product or a procedure described in this article. Neoflash, CC BY-SA 3.0, via Wikimedia Commons · CC BY-SA 3.0
FDA cleared510(k)FDA cleared. Stage 4 of 4 (Authorized)

The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.

Key points

  • Penumbra launched Link, a clot capture device designed to work with its Lightning Bolt aspiration technology in arterial thrombectomy.
  • The FDA's 510(k) database shows clearance K260599 for the 'INDIGO Aspiration System – INDIGO Link' on April 24, 2026; Penumbra's announcement did not cite a clearance number.
  • The launch announcement included one physician's early experience and no clinical trial results.

Penumbra has launched Link, a clot capture device meant to be used alongside its Lightning Bolt computer assisted vacuum thrombectomy (CAVT) technology to remove blood clots from arteries, the Alameda, California, company said in a post on its website dated September 9. Endovascular Today reported the launch on September 10.

According to Penumbra, Link "is designed to lock and hold clot, connecting to the power of computer assisted vacuum thrombectomy (CAVT®) to secure and maximize clot extraction." The device is deployed into the thrombus, where it engages and mobilizes organized clot while aspiration pulls the clot into the aspiration catheter, the company said.

A mechanical option added to aspiration

Penumbra said Link is designed to fit existing Lightning Bolt workflows and can be added when physicians want more mechanical engagement with a clot, "without requiring a fundamentally different procedural approach." The company said the device's architecture is engineered to minimize contact with the vessel wall during extraction.

"Link expands the toolkit available to physicians by providing an additional mechanical clot engagement option that can help address resistant thrombus while maintaining aspiration with CAVT," said James F. Benenati, Penumbra's chief medical officer.

Shruthi Narayan, Penumbra's president, said: "Link represents an important advancement in our CAVT portfolio, providing an additional option for engaging and removing challenging blood clots."

The only clinical experience described in the announcement is a statement from one physician. Thomas Heafner, who used Link with the company's Bolt 7 catheter, said: "Link appeared to provide a secure hold on the embolus, allowing Bolt to more effectively aspirate the residual thrombus." He added: "Combining Link with Lightning Bolt resulted in rapid and effective clot clearance." Penumbra did not release trial data with the launch, and its post states: "The clinical results presented herein are for informational purposes only and may not be predictive for all patients."

The FDA record

Penumbra's announcement did not name a regulatory clearance. The FDA's 510(k) database lists submission K260599 from Penumbra, Inc. for the "INDIGO® Aspiration System – INDIGO Link," received February 24, 2026, and found substantially equivalent on April 24, 2026. The record classifies the device as peripheral mechanical thrombectomy with aspiration, product code QEW, under regulation 870.5150, reviewed by the cardiovascular panel as a traditional 510(k).

Penumbra's post refers readers to the product's instructions for use for its full indications, and says US federal law restricts the device to sale by or on the order of a physician.

Where it fits in Penumbra's line

Narayan described Link as combining "secure clot engagement with the power of modulated aspiration." Endovascular Today, summarising the company's release, reported that Link is intended to support removal of arterial thrombus when used with Lightning Bolt technology, and that Heafner's comments came from his early use of the two together.

Narayan said the launch "reflects our continued commitment to developing technologies that advance vascular care and improve patient outcomes." The company did not disclose pricing or how many centres are using the device.

Sources

  1. Penumbra Launches Link, Expanding Vascular Thrombectomy Options for Physicians, Penumbra, September 9, 2026
  2. Penumbra Launches Link Clot Capture Device for Vascular Thrombectomy, Endovascular Today, September 10, 2026
  3. 510(k) Premarket Notification K260599: INDIGO Aspiration System – INDIGO Link, US Food and Drug Administration, April 24, 2026