CE mark—TrelliX embolic coil system (Shape Memory Medical)
Shape Memory Medical has received the CE mark for its TrelliX embolic coil system. A press release reports that the TrelliX embolic coil system is intended to obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The CE-marked indications include: intracranial aneurysms, other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae, arterial and venous embolisations in the peripheral vasculature. The press release adds that the TrelliX embolic coil system features proprietary shape memory polymer technology.
CE mark— Cascade Agile (Perflow Medical)
Perflow Medical has received CE mark approval for the Cascade Agile Non-Occlusive Remodelling Net (Cascade Agile). Expanding the Cascade product family, a press release reports, the Cascade Agile optimises control for distal and tortuous vessel anatomy during coil embolisation of intracranial aneurysms. The Cascade Agile is the latest addition to Perflow’s portfolio of novel neurovascular devices based on a proprietary technology platform, which includes the Stream Dynamic Neuro-Thrombectomy Net (Stream Net) and Cascade Net.
CE mark—MagicTouch range (Concept Medical)
Concept Medical BV has received the CE mark for is range of MagicTouch drug-coated balloons. The balloons are indicated for peripheral arterial disease, erectile dysfunction, arteriovenous fistula and arteriovenous graft. The CE mark approvals mean that the MagicTouch percutaneous transluminal angioplasty (PTA) catheter is the only commercially available, CE-mark certified, sirolimus-coated balloon catheter for peripheral arterial diseases.
FDA 510(k) clearance—AiCE (Canon Medical)
Canon Medical has received 510(k) clearance on its advanced intelligent Clear-IQ wngine (AiCE) for the Aquilion Precision, which further expands access to its new deep convolutional neural network (DCNN) image reconstruction technology. This technology, now available on both the Aquilion Precision and Aquilion ONE / GENESIS Edition premium computed tomography (CT) systems, uses a deep learning algorithm to differentiate signal from noise so that it can suppress noise while enhancing signal, forging a new frontier for CT image reconstruction.
FDA Breakthrough Device Desgination—CoFITM (CorFlow Therapeutics)
CorFlow Therapeutics has been granted Breakthrough Device designation from the FDA for its CorFlow Controlled Flow Infusion (CoFITM) system. According to a press release, the device is included in the Breakthrough Designation programme with the indication for use statement: “The CoFITM System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI (“stenting”), and to be a platform for controlled infusion of therapeutic agents into the microcirculation with or without vessel occlusion.”