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Technologies & Devices

CMS finalizes renal denervation coverage that benefits Medtronic, Recor

October 28, 2025 By Sean Whooley

Recor Medical Paradise uRDN system Medtronic Symplicity Spyral RDN side by side

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

Filed Under: Applications, Business, Cardiology, Catheters, Regulatory, Technologies & Devices Tagged With: medtronic, ReCor Medical

Pleural Dynamics reports positive data for automatic effusion shunt

October 28, 2025 By Sean Whooley

Pleural Dynamics ACES shunt (1)

Pleural Dynamics today announced positive results from a prospective, multicenter study evaluating its ACES (automatic continuous effusion shunt) device. Plymouth, Minnesota-based Pleural Dynamics developed ACES to treat chronic pleural effusions. It describes it as the first and only fully implantable automatic effusion shunt that uses the motion … [Read more...] about Pleural Dynamics reports positive data for automatic effusion shunt

Filed Under: Shunts, Technologies & Devices Tagged With: Pleural Dynamics

Orchestra BioMed, Terumo terminate drug-eluting balloon distro deal in $30M agreement

October 28, 2025 By Sean Whooley

Orchestra BioMed Virtue sirolimus angioinfusion balloon (SAB)

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

Filed Under: Applications, Balloons, Cardiology, Technologies & Devices, Uncategorized Tagged With: Orchestra BioMed, Terumo

Boston Scientific shares positive Agent drug-coated balloon findings

October 27, 2025 By Sean Whooley

Boston Scientific Agent drug-coated balloon DCB

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

Filed Under: Applications, Balloons, Cardiology, Catheters, Technologies & Devices Tagged With: Boston Scientific

Orchestra BioMed enrolls first patient in Sirolumus AngioInfusion balloon trial

October 27, 2025 By Sean Whooley

Orchestra BioMed Virtue sirolimus angioinfusion balloon (SAB)

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

Filed Under: Applications, Balloons, Cardiology, Catheters, Technologies & Devices Tagged With: Orchestra BioMed

Penumbra study backs mechanical thrombectomy for treating pulmonary embolism

October 27, 2025 By Sean Whooley

Penumbra Lightning Flash 2 computer-assisted thrombectomy system

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

Filed Under: Applications, Cardiology, Catheters, Technologies & Devices Tagged With: penumbra

Multiple studies back Cordis Selution SLR drug-eluting balloon

October 26, 2025 By Sean Whooley

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

Filed Under: Applications, Balloons, Cardiology, Technologies & Devices Tagged With: Cordis

Jupiter Endovascular reports positive first-in-human pulmonary embolectomy system findings

October 26, 2025 By Sean Whooley

Jupiter Endovascular Vertex Pulmonary Embolectomy System

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

Filed Under: Applications, Cardiology, Catheters, Technologies & Devices Tagged With: Jupiter Endovascular

Medtronic reports 3-year blood pressure reductions with Symplicity Spyral RDN

October 26, 2025 By Sean Whooley

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

Filed Under: Applications, Cardiology, Catheters, Technologies & Devices Tagged With: medtronic

Pulse Biosciences enrolls first patient in NANOCLAMP PFA trial

October 24, 2025 By Sean Whooley

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

Filed Under: Applications, Cardiology, Catheters, Pulsed Field Ablation, Technologies & Devices Tagged With: Pulse Biosciences

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