Instylla has announced the US Food and Drug Administration (FDA) 510(k) clearance of the Tembo embolic system.
According to the company, Tembo is a bioresorbable embolization agent composed of irregularly shaped, dry-gelatine particles of a size range from 85 to 255µm. These particles are designed for the embolization of hypervascular tumours and blood vessels to occlude blood flow in the peripheral vasculature.
“We hope that this innovation in short-term absorbable embolics, characterised 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,” commented Venkatesh Krishnasamy (University of Alabama at Birmingham, Birmingham, USA) in the company’s press release. “The Tembo embolic also has the potential to play a key therapeutic role in various other clinical applications and vascular territories.”
Krishnasamy is director of interventional oncology and interventional research and associate professor at the University of Alabama in Birmingham, Alabama.
Additionally, Amar Sawhney, chief executive officer of Instylla and managing director of Incept stated: “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 maximise the clinical benefits of the Tembo embolic system. While our primary focus continues to be the completion of the premarket approval 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.”
