Instylla’s Tembo Embolic System [Image courtesy of Instylla]

Instylla的Tembo栓塞系统[图片由Instylla提供]

Instylla today said it has won FDA 510(k) clearance for its Tembo Embolic System.

Instylla今天表示，其Tembo栓塞系统已获得FDA 510（k）的许可。

Bedford, Massachusetts-based Instylla said the Tembo system is a bioresorbable embolization agent with particles designed for embolization of hypervascular tumors and blood vessels to occlude blood flow in the peripheral vasculature. Those irregularly shaped, dry gelatin particles range in size between 85 and 255 micrometers..

总部位于马萨诸塞州贝德福德的Instylla说，Tembo系统是一种生物可吸收的栓塞剂，其颗粒设计用于栓塞高血管肿瘤和血管，以阻断外周脉管系统的血流。这些不规则形状的干明胶颗粒的尺寸在85到255微米之间。。

“We plan to collaborate with leading experts in interventional radiology to maximize the clinical benefits of the Tembo Embolic System,” Instylla CEO Amar Sawhney said in a

Instylla首席执行官Amar Sawhney在

news release

新闻稿

. “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.”

“虽然我们的主要重点仍然是完成我们的旗舰产品“拥抱水凝胶栓塞系统”的PMA过程，但我们为向专门为新的和现有的栓塞疗法设计的介入放射科医生提供新型可再吸收栓塞剂而感到自豪。”

Sawhney is also managing director of Incept, which founded Instylla in 2017.

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Dr. Venkatesh Krishnasamy, director of interventional oncology and interventional research and associate professor at the University of Alabama said the new system could address limitations associated with currently available permanent spherical embolics.

阿拉巴马大学介入肿瘤学和介入研究主任兼副教授Venkatesh Krishnasamy博士说，新系统可以解决与目前可用的永久性球形栓塞相关的局限性。

“This innovation in short-term absorbable embolics [is] characterized by its irregular shape, easy preparation and use, high visibility, and capacity to pack treated vessels densely. … The Tembo Embolic also has the potential to play a key therapeutic role in various other clinical applications and vascular territories,” Krishnasamy said in the news release..

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