Cheers to Balt for its PMA of the Squid™ liquid embolic agent

Introduction

Balt Inc. is a medical device manufacturer that has given robust coils, catheters and stents products to the healthcare sector. With a total 950 workforce the company aims for interventional neurovascular and neuroradiology solutions. Balt met expansion for the first time after Bridgepints heavevy investment in the company in 2015. Since then, the company inaugurated 16 sites and offices globally.

Announcement

Balt Inc. shared its excitement and took a moment to celebrate Squid™ liquid embolic agents’ Premarket Approval (PMA). This new liquid is like an alternative for the embolisation of the middle meningeal artery (MMA) as a source for general/common treatment in huge symptomatic chronic subdural hematoma(s) (cSDH) patients.

Reason for this Approval

This approval for Squid™ liquid embolic agent is followed by the Squid Trial for the Embolisation of the Middle meningeal artery (STEM), which results in the solution of the chronic Sub-Dural Hematoma study. This study evaluated the force of embolisation on failed treatments, capturing a huge patient cohort. In November 2024, this study was printed in the New England Journal of Medicine.

The published lines illustrated the strength of adjunctive embolisation of the MMA together with Squid, doubling the power to bring more successful treatments in the healthcare frame without any elevated negative symptoms in both patients medically treated or surgery-based.

Trusting this study, the Squid also came in the winning light as this agent is a EVOH related device that introduces different benefits of micronised tantalum and viscosities (12, 18 and 34). This agent’s first appearance was in Europe.

Comments

The PhD (Stony Brook University Medical Center), MD, a STEM Trial Principal Investigator, David Fiorella, while explaining the strategies and efforts, commented, saying, “For the general Chronic subdural hematoma condition, most of the strategies, be it surgical or non-surgical, have met a high volume of failures. It became clear from the primary case involving Dr Adam Arthur and me, who utilised the middle meningeal artery embolization that it seemed to be convincing for the patients.”

“Still a robust data became mandatory to prove the safety and effectiveness of the operation. I feel thankful to Balt’s leadership team as they linked and worked on this vision and came ahead to support STEM. Further, with the huge contribution of STEM patients (participants) and investigators in this trial, we have transformed the neurointerventional space with this commendable new indication. The new tool in Squid is now accessible in the US market, improving patient care.”