News | Interventional Radiology | January 28, 2025

The Tembo Embolic System is a bioresorbable embolization agent comprised of irregularly shaped, dry gelatin particles of a size range from 85-255µm

Tembo Embolic System


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 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."

To learn more, please visit https://www.instylla.com/tembo/

 

1 Data on file at Instylla


Related Content

News | PET-CT

July 25, 2024 — Positron Corporation, a leading molecular imaging medical device company offering PET & PET-CT imaging ...

Time July 25, 2024
arrow
News | RSNA

July 23, 2024 — Professional registration is open for RSNA 2024, the world’s largest radiology forum. This year’s theme ...

Time July 23, 2024
arrow
News | Neuro Imaging

June 12, 2024 — Brainet, a developer of cutting-edge diagnostic tools for assessing brain health, and SimonMed Imaging ...

Time June 12, 2024
arrow
News | ARRS

May 8, 2024 — Compared to males, women in radiology are at a consistently higher risk of not matching into diagnostic ...

Time May 08, 2024
arrow
News | Pediatric Imaging

April 16, 2024 — The Society of Interventional Radiology (SIR) has published a new position statement outlining best ...

Time April 16, 2024
arrow
Feature | Radiation Oncology | By Melinda Taschetta-Millane

In a new 3-part video series on advancements in diagnostic radiology with Robert L. Bard, MD, PC, DABR, FASLMS ...

Time April 10, 2024
arrow
News | Prostate Cancer

March 27, 2024 — A minimally invasive treatment using MRI and transurethral ultrasound instead of surgery or radiation ...

Time March 27, 2024
arrow
News | SIR

March 26, 2024 — Robert J. Lewandowski, MD, FSIR, an interventional radiologist and professor at Northwestern Medicine ...

Time March 26, 2024
arrow
News | SIR

March 26, 2024 — The Society of Interventional Radiology (SIR) inducted 34 new Fellows during its Annual Scientific ...

Time March 26, 2024
arrow
News | SIR

March 25, 2024 — The Society of Interventional Radiology (SIR) Foundation today presented the Leader in Innovation Award ...

Time March 25, 2024
arrow
Subscribe Now