FDA OKs Rapid Medical’s TIGERTRIEVER 25 Thrombectomy Device

Rapid Medical has achieved U.S. Food and Drug Administration (FDA) clearance of the TIGERTRIEVER 25, along with the first clinical cases showing its performance in treating large vessel occlusion (LVO) stroke.

TIGERTRIEVER 25 was designed for large clot burden in proximal vessels. It combines a 53 mm capture length with proprietary real-time force control, allowing physicians to actively control clot interaction during procedures. This aims to drive consistent performance where conventional devices are limited, including long thrombi and stenotic vessels.

According to Rapid Medical, TIGERTRIEVER 25 is the largest thrombectomy device available, engineered to address occlusions in proximal vessels like the internal carotid artery (ICA) and M1 segment, which are among the most challenging cases in stroke intervention. The device merges extended capture length, active operator-controlled expansion, and a distal net designed to maintain clot engagement over long segments.

“With every thrombectomy, we aim at our first pass being the last,” said Edgar Samaniego, MD, MS, University of Iowa, who performed the first U.S. case. “The TIGERTRIEVER 25 demonstrated excellent conformability to the vessel anatomy, accommodating the MCA diameter with a smooth transition into the terminal ICA. This adaptability allows for effective engagement across long segments and makes it particularly valuable in large vessel occlusions with high clot burden, even in challenging, angulated anatomy.”

“Acute ischemic stroke intervention today demands a diverse and adaptable toolkit to effectively address the wide spectrum of anatomical and clinical scenarios we encounter, and I am very impressed with the versatility of the TIGERTRIEVER 25 device,” added Demetrius Lopes, MD of Advocate Health Care. “Its design streamlines the procedural approach and has the potential to simplify the pathway to achieving first-pass success—an outcome that remains critical for improving patient outcomes in mechanical thrombectomy.”

In March, Rapid Medical shared positive results from the DISTALS multicenter, controlled trial showing that its TIGERTRIEVER 13 achieved superior brain tissue reperfusion with an excellent safety profile when compared with medical management in medium vessel occlusion (MVO) stroke.