FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days

MedDevice Startups Staff · Aug 14 · 3 min read · Via FDA 510(k) database, K261523

FDA cleared Jupiter Endovascular's Vertex Thrombectomy System on August 4. The traditional 510(k), K261523, covers non-surgical removal of emboli and thrombi from the pulmonary arteries under product code QEW. It also covers injection and aspiration of contrast and other fluids. FDA received the submission on May 7, so the decision took 89 days. The clearance surfaced in FDA's database. Jupiter has not announced it, and its August 13 release naming Catalin Toma chief medical officer did not mention it.

Vertex is a 26F fixation catheter, a 20F aspiration catheter and an extraction set, used with a commercial vacuum pump. The fixation catheter's shaft is soft for delivery and stiffens on demand when pressurized with saline. That is the Transforming Fixation technology Jupiter spun out of Neptune Medical. The predicate was the Symphony Thrombectomy System (K252057), with the FlowTriever 24 System (K191710) as a reference device.

The 510(k) summary reports SPIRARE II in full: 123 patients at 19 sites in the U.S. and Europe, mean age 61. RV/LV ratio fell from 1.44 to 1.05 at 48 hours, a mean reduction of 0.39. The major adverse event rate was 2.4% against a 25% performance goal. Toma presented those data at EuroPCR in May as global co-principal investigator and joined the company nine days after the clearance.

Jupiter exited stealth in August 2024 with $21M from Sonder Capital and strategic investors. In October 2025 it closed an oversubscribed Series B above its $40M target, led by Sonder with Senvest Management and LB Investment. An 89-day traditional 510(k) with a 123-patient trial attached is fast. Filing with the dataset locked, rather than while the analysis was still open, is the part to copy.

Questions & Answers

What did FDA clear under K261523?

FDA cleared Jupiter Endovascular's Vertex Thrombectomy System on August 4, 2026, for non-surgical removal of emboli and thrombi from the pulmonary arteries, product code QEW. The traditional 510(k) was received on May 7, 2026, an 89-day review.

What were the SPIRARE II trial results for Jupiter Endovascular's Vertex system?

SPIRARE II enrolled 123 patients at 19 sites in the U.S. and Europe. RV/LV ratio fell from 1.44 to 1.05 at 48 hours, a mean reduction of 0.39. The major adverse event rate was 2.4% against a 25% performance goal.

How much has Jupiter Endovascular raised?

Jupiter Endovascular exited stealth in August 2024 with $21M from Sonder Capital and strategic investors. In October 2025 it closed an oversubscribed Series B above its $40M target, led by Sonder with Senvest Management and LB Investment.

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