CE mark— Masters HP 15mm and Amplatzer Piccolo Occluder (both Abbott)
Two of Abbott’s paediatric devices—Masters HP 15mm rotatable mechanical heart valve and the Amplatzer Piccolo Occluder—have received European approval (CE mark). A press release reports that the devices, available in the USA, offer young paediatric patients and their families “hope when no other suitable treatment option may exist”. 

FDA approval—ARTIS icono (Siemens Healthineers)
The FDA has cleared the ARTIS icono (Siemens Healtineers)—a high-precision family of angiography systems that are designed to permit a wide range of minimally invasive procedures to be performed in a single interventional suite. The ARTIS icono biplane system is engineered for optimal use in neuroradiology and abdominal imaging, while the ARTIS icono floor is a floor-mounted, single-plane system for vascular, interventional cardiology, surgical, and oncology procedures. Both systems in the ARTIS icono family expand the reach of precision medicine.

FDA Breakthrough Designation—Virtue SEB (Orchestra BioMed)
Orchestra BioMed, in partnership with Terumo, has secured Breakthrough Device Designation by the FDA for its Virtue sirolimus-eluting balloon (SEB) in the treatment of below-the-knee peripheral arterial disease. A press release reports that currently approved therapeutic options for peripheral arterial disease are limited and have been shown to be marginally effective, leaving substantial unmet need for more effective treatment options for below-the-knee atherosclerosis.

FDA Breakthrough Designantion– NUsurface Meniscus implant (Active Implants)
Active Implants has announced that the NUsurface Meniscus implant has been granted a Breakthrough Device Designation from the FDA. A press release reports that the NUsurface Meniscus implant is the first “artificial meniscus” to be marketed in Europe and, if cleared by the FDA, would be the first artificial meniscus in the USA.

FDA 510(k) clearance and CE mark—Avenir coil system (Wallaby Medical)
Wallaby Medical announces CE mark approval and FDA 510(k) clearance of its differentiated embolic coil system—the Avenir coil System. The intended use for the Avenir coil system is for endovascular embolisation of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The Avenir coil system is also intended for arterial and venous embolisation in the peripheral vasculature.

FDA Fast Track Designation—Farixga (AstraZeneca)
The FDA has granted Fast Track Designation for the development of dapagliflozin (Farixga, AstraZeneca) to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF). The FDA’s Fast Track programme is designed to accelerate the development and review of new medicines for the treatment of serious conditions where there is an unmet treatment need.

FDA IDE approval—pDVA (LimFlow)
LimFlow has received FDA approval for its investigational device exemption (IDE) for the PROMISE II pivotal study of the LimFlow percutaneous deep vein arterialisation (pDVA) system. PROMISE II is a multicentre, prospective, single-arm study to be conducted in the USA and Japan. Using an adaptive statistical design, the study plans to enrol 60 to 120 “no option” chronic limb-threatening ischaemia (CLTI) patients.

MDR—Class III (Biotronik)
Biotronik has become the world’s first manufacturer to receive European Medical Device Regulation (MDR) certification for a Class III (highest risk) medical device. Following a successful conformity assessment, the company also obtained MDR certification for its quality management system.