Embolic System from Instylla Nets FDA Clearance
Instylla, Inc. announced FDA 510(k) clearance of the Tembo Embolic System a bioresorbable embolization agent comprised of irregularly shaped, dry gelatin particles of a
size range from 85-255µm. These particles are designed for the embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature.
Over the past 30 years, peripheral vascular embolization has significantly expanded, now encompassing a wide range of applications, including the treatment of vascular malformations, uterine artery embolization, prostatic artery embolization, hypervascular tumor embolization, genicular artery embolization, and the management of endoleaks, among other uses.
Dr Venkatesh Krishnasamy, Director of Interventional Oncology and Interventional Research and Associate Professor at the University of Alabama, commented, "We hope that this innovation in short-term absorbable embolics, characterized by its irregular shape, easy preparation and use, high visibility, and capacity to pack treated vessels densely, will potentially address the limitations associated with currently available permanent spherical embolics. The Tembo Embolic also has the potential to play a key therapeutic role in various other clinical applications and vascular territories."
"We are excited to achieve 510(k) clearance for the Tembo Embolic System and eagerly anticipate introducing this product to the US market. We plan to collaborate with leading experts in interventional radiology to maximize the clinical benefits of the Tembo Embolic System," said Amar Sawhney, CEO of Instylla, Inc. and Managing Director of Incept, LLC. "While our primary focus continues to be the completion of the PMA process for our flagship product, Embrace Hydrogel Embolic System, we pride ourselves on providing novel resorbable embolic agents to interventional radiologists specifically designed for new and existing embolotherapies."
