Orchestra BioMed (Nasdaq:OBIO) announced today that it entered into a termination and right of first refusal agreement with Terumo. The agreement relates to the New Hope, Pennsylvania–based company's Virtue Sirolimus AngioInfusion Balloon (SAB). It supersedes and terminates a prior distribution agreement between the companies and grants Terumo a … [Read more...] about Orchestra BioMed, Terumo terminate drug-eluting balloon distro deal in $30M agreement
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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
Multiple studies back Cordis Selution SLR drug-eluting balloon
Cordis today announced new findings from a duo of studies supporting the use of its Selution SLR drug-eluting balloon (DEB) system. Miami Lakes, Florida-based Cordis announced results from the SELUTION DeNovo and SELUTION 4ISR trials at the 2025 Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Both randomized clinical … [Read more...] about Multiple studies back Cordis Selution SLR drug-eluting balloon
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
Terumo enters U.S. imaging market with FDA nod for dual-sensor system
Terumo Interventional Systems announced today that it received FDA 510(k) clearance for its OpusWave dual-sensor imaging system. OpusWave features the DualView imaging catheter, which received FDA 510(k) clearance alongside the entire system. The platform combines optical frequency domain imaging (OFDI) and intravascular ultrasound (IVUS). It aims … [Read more...] about Terumo enters U.S. imaging market with FDA nod for dual-sensor system
Abbott gets FDA breakthrough nod for dual-energy ablation catheter
An Abbott [WtwhTicker symbol="ABT"](NYSE: ABT)[/WtwhTicker] official posted on social media to announce FDA breakthrough device designation for a new ablation catheter. Abbott SVP Uri Yaron said on LinkedIn that the FDA granted the breakthrough nod for the TactiFlex Duo Sensor-Enabled catheter. The catheter features a dual-energy modality for the … [Read more...] about Abbott gets FDA breakthrough nod for dual-energy ablation catheter
