Instylla Receives FDA Clearance for Embolic System

Instylla Receives FDA Clearance for Embolic System

tim.hodson Wed, 01/29/2025 - 11:07 Jan. 28, 2025 — Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, has announced the FDA 510(k) clearance of the Tembo Embolic System. The Tembo Embolic System is a bioresorbable1 embolization agent comprised of irregularly shaped, dry gelatin particles of a size range from 85-255µm1. These particles are designed for the embolization of hypervascu…

New interventional embolotherapy system lands FDA clearance

The bioresorbable agent is made from small irregularly shaped, dry gelatin particles designed for the embolization of hypervascular tumors and blood vessels.

Instylla’s Tembo Embolic System Receives FDA Clearance - Endovascular Today

January 28, 2025—Instylla, Inc., a developer of solutions for peripheral vascular embolotherapy, announced the FDA 510(k) clearance of the Tembo embolic system. According to the company, Tembo is a bioresorbable embolization agent composed of irregularly shaped, dry-gelatin particles of a size range from 85 to 255 µm. These particles are designed for the embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripher…