As the laboratory research host for startup company Metactive Medical, M2D2 is thrilled to spread the word about the most recent trials of their innovative devices, the Blockstent Microcatheter™ and Ballstent Microcatheter™.
Blockstent Microcatheter™
The Blockstent Microcatheter™ is a novel peripheral vascular embolization device comprising a 3.3 Fr, highly flexible .014″ guidewire-compatible microcatheter delivery system and an inflatable, detachable metallic balloon that delivers immediate, complete, and lasting vessel occlusion.
More than 400,000 peripheral artery and vein embolization procedures are performed worldwide each year using coils and vascular plugs. However there remains a need for peripheral artery and vein embolization devices that are highly flexible and deliverable, can be placed with a high degree of precision, are resistant to migration, and provide immediate, complete, and lasting artery and vein occlusion. This is where the Blockstent Microcatheter™ will come into play.
The Results
In a comparison study between the Blockstent Microcatheter™ and Amplatzer™ Vascular Plugs and Cook Nester® Embolization Coils in a Canine Model of Acute and Chronic Arterial Occlusion, Metactive found that the placement of their Microcatheter resulted in immediate and complete occlusion in all eight treatments, while the arteries treated with Amplatzer™ Vascular Plugs or Nester® Coils did not. At the 4-week follow-up, the mean arterial occlusion for the Blockstent Microcatheter was 98%, compared to 57% with Amplatzer™ Vascular Plugs and 81% with Nester® Coils.
This is exciting news because these results indicate a potential for the Metactive device to fulfill the widespread need for a better replacement to coils and vascular plugs.
Ballstent Microcatheter™
At the same time, Metactive has also been working on a novel saccular aneurysm embolization device comprising a 3.3 Fr, highly flexible .014″ guidewire-compatible microcatheter delivery system and an inflatable, detachable, intrasaccular metallic balloon that can be used with coils to provide immediate, complete, and lasting aneurysm occlusion and rapid endothelialization of the aneurysm neck.
More than 80,000 cerebral aneurysm embolization procedures are performed worldwide each year using coils, flow-diverting stents, intra-saccular devices, and liquid embolics. According to the following early results, the Ballstent Microcatheter™ may be able to fill the need for cerebral aneurysm embolization devices that are highly flexible and deliverable, can be placed with a high degree of precision within the aneurysm sac, and provide immediate, complete, and lasting aneurysm neck and sac occlusion.
The Results
The study, which compared the treatment of Carotid Artery Terminal Bifurcation, Complex Bifurcation, and Sidewall Aneurysms in Canines with the Ballstent Microcatheter™ versus commercially available coils, produced promising results. At the follow-up, nine out of ten aneurysms treated demonstrated 100% aneurysm neck and sac occlusion by histology. The remaining aneurysm demonstrated 95% occlusion, with recanalization of a small segment of the aneurysm neck that had been treated with a single coil during a follow-up procedure. All aneurysms demonstrated rapid and complete or near-complete endothelialization of the aneurysm neck, a critical requirement for an effective and durable treatment of saccular aneurysms. An additional large, narrow-necked terminal carotid artery bifurcation aneurysm was treated with 17 commercially available coils alone. This aneurysm did not show complete occlusion by angiography immediately after treatment or at four weeks, and histology demonstrated only 67% aneurysm neck occlusion with recanalization channels extending into the aneurysm sac.
“In this nonclinical study, the Ballstent Microcatheter™, when used with a few coils, delivered rapid and complete occlusion of the neck and sac of a wide range of aneurysm sizes, shapes and configurations, including hard-to-treat large, wide-necked bifurcation and terminal aneurysms,” said Dr. Kieran Murphy, Professor, Vice Chair, and Director of Research in the Department of Medical Imaging at the University of Toronto. “The study also showed good biocompatibility for the Ballstent and rapid endothelialization of the aneurysm neck after treatment. This new device has the potential to be useful for patients with large aneurysms, aneurysms arising from bifurcations, ruptured aneurysms, and aneurysms in patients who would benefit from avoiding long-term anticoagulation.”
Exciting Future Developments in Healthcare
Though still in the early stages of research and development, the results from these trials look encouraging for the future of the medical device world. With the potential for the Blockstent Microcatheter™ and Ballstent Microcatheter™ to go to market and become commercialized on the horizon, the way the healthcare industry goes about treating these prevalent conditions may soon be changing for the better. M2D2 is proud to support Metactive in their continuing endeavor to improve healthcare through innovation.
About Metactive Medical
Metactive is developing innovative new medical devices for the treatment of neurovascular and peripheral vascular diseases. Metactive’s first products enable precise and immediate occlusion and rapid sealing of cerebral aneurysms, arteries, and veins using an over-the-wire microcatheter platform. For more information, please visit www.metactivemedical.com.