The FDA issued an early alert after Baxter (NYSE:BAX) recommended the removal of certain Duo-Vent intravascular administration sets. Baxter sent all affected customers a letter on June 30, telling them to immediately identify, quarantine and return affected lots. The communication affects lots DR26C27062, DR26D14031 and DR26E13055 of the Duo-Vent solution set and male luer lock adapter. Duo-Vent […]
Vascular
Abbott gets FDA nod for longer length Esprit BTK drug-eluting scaffold
Abbott (NYSE:ABT) announced today that the FDA approved the longer length (76 mm) Esprit BTK drug-eluting scaffold system. The longer Esprit BTK system received approval for the treatment of chronic limb-threatening ischemia (CLTI), a severe form of peripheral artery disease (PAD). CLTI can cause extreme pain, open wounds that don’t heal and, in some cases, […]
Advanced NanoTherapies raises $31M for drug-coated balloon tech
Advanced NanoTherapies announced that it closed an oversubscribed Series B financing worth more than $31 million. An undisclosed strategic investor, along with S3 Ventures, co-led the round. The T45 Fund and new and existing investors also participated. Funding adds to $4 million raised in 2023. The funds support the company’s therapies for coronary and peripheral […]
Reflow Medical has positive data for coronary drug-eluting stent
Reflow Medical today announced the first six-month clinical results from a study of its Spur Elute sirolimus-eluting retrievable stent system. San Clemente, California-based Reflow designed its stent system to transfer a proprietary drug formulation to the diseased lesion without leaving a permanent metallic implant behind. The device’s retrievable scaffold therapy creates channels to increase the […]
Elixir Medical study backs DynamX bioadaptor against drug-eluting stent
Elixir Medical today announced four-year results from a study comparing its DynamX coronary bioadaptor system to a leading drug-eluting stent (DES). The BIOADAPTOR randomized controlled trial compared DynamX to the Medtronic Resolute Onyx DES, the current standard of care. It compared the therapies across Japan, Europe and New Zealand. Investigators shared findings from 445 patients […]
Abbott has positive drug-eluting scaffold data
Abbott (NYSE:ABT) today shared promising 30-day results for its Esprit BTK everolimus-eluting resorbable scaffold system. Esprit features materials similar to dissolving sutures. Unlike metal stents, it’s not a permanent implant, providing support for blocked vessels only for a few months after the blockage is cleared. At that point, the vessel can remain open on its […]
InVera wins FDA clearance for non-thermal infusion catheter
InVera Medical announced today that it received FDA 510(k) clearance for its InVera Infusion Device. Galway, Ireland-based InVera designed its minimally invasive device to help physicians deliver treatment more effectively to diseased leg veins, including varicose veins. It aims to treat chronic venous disease (CVD), which currently faces a significant gap in care, the company […]
Abbott earns CMS reimbursement win for Esprit drug-eluting scaffold
An Abbott (NYSE:ABT) official has shared a significant reimbursement win for its Esprit BTK drug-eluting scaffold system. On LinkedIn, SVP and President of Abbott Vascular, Julie Tyler, posted that the Centers for Medicare & Medicaid Services (CMS) approved transitional pass-through (TPT) payment status for Esprit BTK. TPT, a three-year program, ensures that Medicare beneficiaries can […]
Airiver Medical wins FDA breakthrough nod for drug-coated balloon, treats first patient
Airiver Medical announced today that it received FDA breakthrough device designation for its pulmonary drug-coated balloon (DCB). Additionally, Airiver announced the first treated patients in a clinical trial for the DCB. The Brooklyn Park, Minnesota-based company designed its DCB to treat central airway stenosis. Central airway stenosis (airway narrowing) can lead to prolonged intubation, tracheostomy, […]
InVera Medical wins European approval for vein infusion device
InVera Medical announced recently that it picked up European approval for its minimally invasive device for delivering vein treatments. The Galway, Ireland-based company designed its device to help deliver treatment more effectively to diseased leg veins, including varicose veins. CE mark approval enables the marketing of the InVera Infusion Device across the European Union. According […]
