VVT Medical announced in recent months that FDA has cleared its ScleroSafe platform, which delivers endovenous chemical ablation to treat superficial varicose veins. Kfar Saba, Israel–based VVT Medical says it specifically created ScleroSafe to provide efficient, non-thermal, non-tumescent treatment and management of varicosities in superficial veins. Its inverse-action dual syringe injects the ECA substance into […]
Vascular
Advanced NanoTherapies picks up $4M investment for drug-coated balloon development
Advanced NanoTherapies announced today that it collected a $4 million Series A extension from an undisclosed strategic investor. Los Gatos, California-based Advanced NanoTherapies received the investment from a medical device company. It also announced the successful treatment of the first cohort of study participants in its drug-coated balloon trial. The first-in-human trial evaluates initial short-term […]
Orchestra BioMed wins FDA IDE for drug-coated balloon study
Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its Virtue SAB. The IDE enables the Virtue ISR-US pivotal study. It evaluates Virtue SAB, a novel AngioInfusion balloon for treating artery disease, in treating patients with coronary ISR. New Hope, Pennslyvania-based Orchestra BioMed designed Virtue SAB to enable the protected […]
FDA approves Surmodics SurVeil drug-coated balloon
Surmodics (Nasdaq:SRDX) announced today that the FDA granted approval for its SurVeil drug-coated balloon (DCB). Eden Prairie, Minnesota-based Surmodis may now market and sell SurVeil in the U.S. for percutaneous transluminal angioplasty. Use follows appropriate vessel preparation or de novo or restenotic lesions in femoral and popliteal arteries. These arteries feature reference vessel diameters of […]
BD continues to expand in Ireland
BD (NYSE:BDX) announced that it opened a new facility in Ireland and committed a further investment within the country. Last week, the company held a grand opening ceremony for a new $4.3 million (€4 million) R&D facility in Blackrock, Dublin. BD also announced an additional $32.1 million (€30 million) investment to expand its Enniscorthy, Wexford […]
Aerami presents positive data for inhaled pulmonary hypertension treatment
Aerami Therapeutics today announced positive data supporting its inhaled imatinib for treating pulmonary hypertension (PH). Studies of AER-901 support progression into a Phase 2 clinical trial. Data backed Aerami’s treatment for both PH associated with interstitial lung disease (PH-ILD) and pulmonary arterial hypertension (PAH). AER-901 is a drug-device combination. Aerami designed it to deliver potentially […]
Fresenius Kabi launches single-needle option for extracorporeal photopheresis
Fresenius Kabi announced the availability of a single-needle venous access option for its Amicus extracorporeal photopheresis (ECP) system. The company announced its availability at the 49th annual meeting of the European Society for Blood and Marrow Transplantation (EBMT). Fresenius Kabi first launched the Amicus Blue system with online ECP in Europe in 2019 with double-needle venous […]
MedAlliance picks up FDA IDE nod for drug-eluting balloon
MedAlliance announced today that its novel sirolimus-eluting balloon received conditional FDA investigational device exemption (IDE). Geneva, Switzerland-based MedAlliance can now initiate its pivotal clinical trial for the treatment of coronary de novo lesions. MedAlliance received its first IDE for Selution SLR in below-the-knee indications in May 2022. It picked up a second IDE in August. […]
Boston Scientific to acquire majority stake in interventional tech developer Acotec
Boston Scientific (NYSE:BSX) announced that it intends to make a partial offer to acquire a majority stake in Acotec. Marlborough, Massachusetts-based Boston Scientific’s offer could add up to a maximum of 65% of Acotec’s shares. Its proposed price totals HK$20 per share. That amounts to approximately $523 million for the 65% stake at current exchange […]
B. Braun buys catheter securement device portfolio from Starboard
B. Braun Medical announced today that it acquired the Clik-FIX catheter securement device portfolio from Starboard Medical. Clik-FIX adds to B.Braun’s offerings that help improve patient experiences and outcomes for peripheral intravenous (IV) therapy. Get the full story at our sister site, MassDevice.
