Surmodics (Nasdaq:SRDX) announced results from a sex-specific analysis of real-world patients in a study of its Pounce thrombectomy system. The analysis evaluated 160 acute, subacute and chronic thrombotic limb ischemia patients from the PROWL registry. Dr. Peter Monteleone presented findings at the 2025 Transcatheter Cardiovascular Therapeutics … [Read more...] about Surmodics reports real-world Pounce thrombectomy system findings
Catheters
Hyperion completes first-in-human study of Ivy robotic vascular access platform
Hyperion Surgical announced today that it completed the world's first robotic-assisted intravenous (IV) catheterization using its Ivy platform. Ivy integrates advanced imaging, AI and robotic precision in a robotic vascular access platform to enable a no-touch approach to IV placements. Miami-based Hyperion's clinical team performed the procedure … [Read more...] about Hyperion completes first-in-human study of Ivy robotic vascular access platform
FastWave Medical reports first-in-human findings for Sola laser IVL system
FastWave Medical today announced new first-in-human and pre-clinical data for its Sola coronary laser intravascular lithotripsy (L-IVL) system. Minneapolis-based FastWave designed Sola to treat cardiovascular calcium with sleek, rupture-resistant balloon catheters. Its custom laser energy source produces actuating, circumferential sonic pressure … [Read more...] about FastWave Medical reports first-in-human findings for Sola laser IVL system
CMS finalizes renal denervation coverage that benefits Medtronic, Recor
CMS today issued its final National Coverage Determination (NCD) on renal denervation (RDN), marking a major win for Medtronic [WtwhTicker symbol="MDT"](NYSE: MDT)[/WtwhTicker] and Recor Medical. Both companies develop their own RDN systems. Recor Medical received the first FDA nod for its Paradise ultrasound RDN (uRDN) system in November 2023. … [Read more...] about CMS finalizes renal denervation coverage that benefits Medtronic, Recor
Boston Scientific shares positive Agent drug-coated balloon findings
Boston Scientific (NYSE: BSX) today shared findings from new analyses of its Agent drug-coated balloon (DCB). Agent serves as an alternative to traditional therapies like balloon angioplasty, additional layers of stenting or radiation. The paclitaxel-coated balloon transfers a therapeutic dose of drug to the vessel wall, helping to prevent … [Read more...] about Boston Scientific shares positive Agent drug-coated balloon findings
Orchestra BioMed enrolls first patient in Sirolumus AngioInfusion balloon trial
Orchestra BioMed (Nasdaq:OBIO) today announced the first patient enrollments in a study of its Virtue Sirolimus AngioInfusion Balloon (SAB). The FDA investigational device exemption (IDE) trial compares the Virtue SAB to the Boston Scientific Agent paclitaxel-coated balloon. Agent is currently the only FDA-approved drug-coated balloon (DCB) for … [Read more...] about Orchestra BioMed enrolls first patient in Sirolumus AngioInfusion balloon trial
Penumbra study backs mechanical thrombectomy for treating pulmonary embolism
Penumbra (NYSE:PEN) today announced positive results from its landmark STORM-PE randomized controlled trial. The study found that the use of the company's computer-assisted vacuum thrombectomy (CAVT) system, a form of mechanical thrombectomy (MT), with anticoagulation achieved superior reduction in right heart strain compared to anticoagulation … [Read more...] about Penumbra study backs mechanical thrombectomy for treating pulmonary embolism
Jupiter Endovascular reports positive first-in-human pulmonary embolectomy system findings
Jupiter Endovascular today announced positive results from the first-in-human study of its Vertex pulmonary embolectomy system. SPIRARE I evaluates the Vertex system featuring transforming fixation (TFX) technology in patients with acute, intermediate-risk pulmonary embolism (PE). Vertex incorporates Jupiter’s novel technology into an endovascular … [Read more...] about Jupiter Endovascular reports positive first-in-human pulmonary embolectomy system findings
Medtronic reports 3-year blood pressure reductions with Symplicity Spyral RDN
Medtronic (NYSE: MDT) today announced new long-term results from its final report of the SPYRAL HTN-ON MED trial. SPYRAL HTN-ON MED is a global, randomized, sham-controlled trial investigating the blood pressure-lowering effect and safety of renal denervation (RDN) with the radiofrequency-based Symplicity Spyral RDN system in hypertensive patients … [Read more...] about Medtronic reports 3-year blood pressure reductions with Symplicity Spyral RDN
Pulse Biosciences enrolls first patient in NANOCLAMP PFA trial
Pulse Biosciences (Nasdaq:PLSE) today announced the enrollment of the first patient in its NANOCLAMP AF study for treating AFib. In September, the FDA granted investigational device exemption (IDE) for Pulse's nanosecond pulsed field ablation (nsPFA) system. Approval gave Pulse the green light to proceed with the initiation of the NANOCLAMP AF … [Read more...] about Pulse Biosciences enrolls first patient in NANOCLAMP PFA trial
