Radical Catheter's New 6F Device Cleared, Advancing Brain Treatments

LOS GATOS, Calif. – April 13, 2026 – Radical Catheter Technologies announced today it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its new 6F neurovascular access catheter, a move poised to enhance precision and expand options for minimally invasive brain procedures. The clearance marks the third such approval for the NeuroTechnology Investors (NTI) portfolio company, signaling a significant step in its plan to address long-standing challenges in neuroendovascular surgery.

The device is designed to improve access and performance in complex anatomies, particularly for middle-meningeal artery (MMA) embolization—a growing treatment for chronic brain bleeds—and procedures performed via the wrist’s radial artery, a less invasive approach gaining widespread favor.

A Leap in Precision for Neurovascular Interventions

For years, neurointerventionalists have navigated a delicate balance, requiring catheters that are flexible enough to traverse the brain's tortuous vascular pathways but also stable and supportive enough to deliver therapeutic devices accurately. Radical Catheter Technologies asserts its new device directly confronts what its CEO, Brian Martin, calls “performance gaps physicians have long identified.”

The catheter is built upon a proprietary “ribbon technology,” a patented design intended to deliver simultaneous flexibility, pushability, and stability. This engineering aims to provide physicians with superior control and durability when navigating challenging anatomy. Furthermore, the device features a thinner wall construction, which allows for a larger inner diameter relative to its outer profile. This critical design choice enables the smooth passage of a wider array of therapeutic tools, such as coils and stents, potentially improving procedural efficiency and success rates.

This combination of features has already garnered praise from clinical experts. “The FDA clearance of the 6F Radical catheter is a meaningful advancement for our patients,” said Johanna Fifi, MD, a neurovascular surgeon and Professor at The Mount Sinai Hospital in New York. “The 6F’s lower profile delivers best-in-class performance across both radial and femoral access. Built on the foundation Radical Catheter Technologies has already established, the 6F becomes an immediate top choice, particularly in challenging cases.”

Riding the Wave of Radial Access

The clearance is particularly timely as it aligns with a major clinical shift toward transradial access (TRA) for neurovascular procedures. Traditionally performed through the femoral artery in the groin, these interventions are increasingly being initiated through the radial artery in the wrist. The trend, which mirrors a similar evolution in cardiology, is driven by significant patient benefits.

Clinical data shows that TRA is associated with fewer major bleeding events, reduced access site complications, and greater patient comfort. Patients can often sit up and move around sooner after a procedure, leading to faster recovery and potentially shorter, more cost-effective hospital stays. The global market for transradial access products reflects this momentum, with projections showing growth from approximately $2.4 billion in 2024 to over $4.1 billion by 2032.

However, the radial route presents its own technical hurdles, including a more tortuous path to the cerebral arteries. Radical’s 6F catheter, with its lower profile and enhanced navigability, is specifically engineered to overcome these challenges, providing a tool optimized for this patient-centric approach.

Targeting New Frontiers in Brain Bleed Treatment

Beyond improving access, the new catheter is set to play a key role in the expanding application of middle meningeal artery (MMA) embolization for treating chronic subdural hematomas (cSDH), a common condition, especially among the elderly, involving a slow bleed on the surface of the brain. While traditionally managed with open surgery, MMA embolization offers a minimally invasive alternative that is rapidly gaining traction.

Academic interest and clinical adoption of this technique have surged in recent years, with the market for MMA embolization devices projected to nearly double from roughly $312 million in 2024 to over $613 million by 2033. The success of this procedure hinges on the ability to safely navigate to the target artery and deliver embolic agents. A low-profile, highly navigable access catheter like the 6F is a critical component of the procedural toolkit, enabling physicians to perform this delicate work with greater confidence and efficiency.

A Strategic Play in a Competitive Market

The FDA clearance positions Radical Catheter Technologies to compete in the formidable neurovascular device market, an arena currently dominated by industry giants like Stryker, Medtronic, and Penumbra. The global market, valued at over $3.4 billion, is projected to more than double by 2033, fueled by an aging population and the increasing prevalence of neurological conditions like stroke and brain aneurysms.

This launch is not just about a single product but is part of a larger, integrated strategy orchestrated by its parent investment group, NeuroTechnology Investors (NTI). NTI is building a portfolio of synergistic companies to create a comprehensive neurotechnology ecosystem. The press release highlights a plan to integrate Radical’s access and delivery capabilities with technologies from other NTI companies, such as Serenity Medical’s River™ stent for idiopathic intracranial hypertension.

“We have spent years developing a truly innovative, best-in-class catheter platform,” said Brian Martin, CEO and co-founder of Radical Catheter Technologies. “With our novel technology, we are exceeding these expectations and positioning the Radical platform to serve as the foundation for continued innovation in neuroendovascular procedures.”

This collaborative commercialization model aims to unite compelling technologies and provide the infrastructure to bring them to market more effectively. “This commercialization model unites some of the most compelling technologies in the neurovascular space, while providing the infrastructure to advance and support the best-in-class solutions we represent,” added Alex Thomson, the company’s Vice President of Commercial.

Radical Catheter Technologies plans to showcase its platform at the Society of Neurointerventional Science’s (SNIS) 23rd Annual Meeting in Seattle this July, where it will appear alongside fellow NTI portfolio companies Synchron, Serenity Medical, and Borvo Medical. This joint appearance underscores the group’s unified strategy to advance a new generation of transformative neurological solutions.