Instylla's Tembo Embolic System Receives FDA Clearance for Peripheral Vascular Embolization
Key Insights
Instylla (search), Inc. has received FDA 510(k) clearance for its Tembo Embolic System (search), a bioresorbable agent for peripheral vascular embolization.
The Tembo Embolic System (search) is designed to occlude blood flow in hypervascular tumors (search) and vessels using irregularly shaped gelatin particles.
The system offers potential advantages over permanent spherical embolics due to its shape, visibility, and vessel-packing capacity.
Instylla (search), Inc., a clinical-stage company focused on peripheral vascular embolotherapy, announced that the FDA has granted 510(k) clearance for its Tembo Embolic System (search). This system is designed for the embolization of hypervascular tumors (search) and blood vessels, effectively blocking blood flow in the peripheral vasculature.
The Tembo Embolic System (search) utilizes bioresorbable embolization agents composed of irregularly shaped, dry gelatin particles ranging from 85 to 255 micrometers. These particles are intended for short-term vessel occlusion, offering a temporary alternative to permanent solutions.
Potential Advantages of Tembo Embolic System
Dr. Venkatesh Krishnasamy, Director of Interventional Oncology and Interventional Research at the University of Alabama, highlighted the potential benefits of the Tembo Embolic System (search). "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," he stated. He also noted the potential for the Tembo embolic to play a key therapeutic role in various other clinical applications and vascular territories.
Company's Perspective
Amar Sawhney, CEO of Instylla (search), Inc., expressed enthusiasm about the FDA clearance and the company's plans for the product. "We are excited to achieve 510(k) clearance for the Tembo Embolic System (search) and eagerly anticipate introducing this product to the United States market," said Sawhney. He also mentioned Instylla's commitment to providing novel resorbable embolic agents for interventional radiologists, while continuing to focus on the premarket approval process for their Embrace Hydrogel Embolic System (search).
Clinical Applications
Peripheral vascular embolization has expanded significantly over the past 30 years, now encompassing a wide range of applications. These include the treatment of vascular malformations (search), uterine artery embolization, prostatic artery embolization, hypervascular tumor embolization, genicular artery embolization, and the management of endoleaks (search).