Procyrion announced today that it enrolled the first patient in its investigational device exemption trial of the Aortix system. The DRAIN-HF study evaluates the Aortix percutaneous mechanical circulatory support (pMCS) technology. Patients in the trial present acute decompensated heart failure (ADHF) and remain unresponsive to standard medical therapy. Dr. Bassem Chehab enrolled the first patient […]
Vascular
BD launches SiteRite vascular access ultrasound system
BD announced today that it launched its new SiteRite 9 advanced ultrasound system for helping with vascular access device placement. Franklin Lakes, New Jersey-based BD designed the system to help improve clinician efficiency when placing these devices. They include peripherally inserted central catheters (PICCs), central venous catheters, IV lines and other vascular access devices. SiteRite […]
First patient enrolled in Penumbra study of computer-assisted vacuum thrombectomy
Penumbra (NYSE:PEN) today announced the first patient enrolled in STORM-PE, a trial of its Lightning Flash thrombectomy system. Lightning Flash, a mechanical thrombectomy system, received FDA clearance in January. The system features Penumbra’s novel Lightning intelligent aspiration technology with dual-clot detection algorithms. Combining it with innovative catheter engineering, Penumbra designed Lightning Flash to quickly remove […]
Teleflex enrolls first patient in registry of vascular closure device for TAVR
Teleflex announced today that it enrolled the first patient in a clinical registry evaluating its Manta vascular closure device (VCD). The company aims for the registry to examine and collect data on outcomes of contemporary on-label use of Manta in standard of care transcatheter aortic valve replacement (TAVR) procedures. It includes appropriate patient selection and […]
Surmodics has positive data on multiple drug-coated balloons
Surmodics (Nasdaq:SRDX) today announced positive study results for two of its drug-coated balloon (DCB) technologies. The company presented data supporting the SurVeil and Sundance DCBs at the 50th Annual VEITH Symposium in New York. In the TRANSCEND trial, Surmodics evaluated the safety and efficacy of SurVeil versus the Medtronic In.Pact Admiral DCB. The trial evaluated […]
Inari Medical closes LimFlow acquisition
Inari Medical announced that it completed its acquisition of chronic limb-threatening ischemia (CLTI) treatment maker LimFlow. The Irvine, California–based company earlier this month announced plans to acquire LimFlow for up to $415 million. The deal came just weeks after Paris-based LimFlow won FDA premarket approval (PMA) for its breakthrough CLTI treatment. Inari Medical intends to […]
Silk Road Medical names a new CEO
Silk Road Medical (Nasdaq:SILK) announced today that it appointed Chas McKhann as its new CEO, effective immediately. Located in Sunnyvale, California and Plymouth, Minnesota, Silk Road Medical is focused on reducing stroke risk through a carotid artery disease treatment called TransCarotid Artery Revascularization (TCAR). The company announced last month that CEO Erica Rogers intended to […]
Inari Medical plans to buy LimFlow Medical for up to $415M
Inari Medical today announced a definitive agreement to purchase LimFlow Medical for up to $415 million. The deal comes just weeks after Paris-based LimFlow won FDA premarket approval (PMA) for its breakthrough system to treat chronic limb-threatening ischemia (CLTI). San Jose, California–based Inari said it expects to complete the acquisition by the end of 2023. […]
Cardio Flow announces first commercial FreedomFlow uses, appoints new COO
Cardio Flow today announced the successful completion of the first commercial cases for its FreedomFlow orbital atherectomy platform. FreedomFlow, a device designed to treat peripheral artery disease (PAD), received FDA clearance earlier this month. Dr. Craig Walker, Dr. Pradeep Naier and Dr. McCall Walker performed the initial U.S. cases with the device. The procedures took […]
Abbott has positive data for Esprit drug-eluting resorbable scaffold
Abbott today announced data supporting its Esprit BTK everolimus-eluting resorbable scaffold system. The company designed Esprit BTK to treat people with chronic limb-threatening ischemia (CLTI), a severe stage of peripheral artery disease (PAD). Abbott said its LIFE-BTK trial met both of its primary safety and effectiveness endpoints. It demonstrated the reduction of disease progression and […]
Shockwave Medical launches new coronary IVL catheter following FDA approval
Shockwave Medical announced today that it unveiled a new coronary intravascular lithotripsy (IVL) catheter in the U.S. The planned introduction of the Shockwave C2+ coronary IVL catheter follows the receipt of FDA approval. This catheter offers 50% more pulses per catheter than the Shockwave C2 catheter that the FDA approved in June 2021. Santa Clara, California-based […]