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Stent Restenosis Articles & Analysis: Older

13 news found

£1.1 million project to develop new biodegradable stents

£1.1 million project to develop new biodegradable stents

However, these metal stents are associated with early blood clots and long-term chronic inflammation at the stented site. This triggers recurrence of blockages within one to two years (also known as in-stent restenosis) leading to readmissions, repeated revascularisation and huge hospital costs. ...

ByArterius Limited


ELIXIR MEDICAL COMPLETES ENROLLMENT IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

ELIXIR MEDICAL COMPLETES ENROLLMENT IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

JAMA Cardiol.2019;4(12):1261–1269. doi:10.1001/jamacardio.2019.4101 Nakamura M, Yock PG, Bonneau HN, et al. Impact of peri-stent remodeling on restenosis: a volumetric intravascular ultrasound study. ...

ByElixir Medical Corporation


Orchestra BioMed Announces Peer-Reviewed Publication of MODERATO II Study Results Showing a Statistically Significant Reduction in Blood Pressure in Pacemaker-Indicated Patients Treated with BackBeat Cardiac Neuromodulation Therapy

Orchestra BioMed Announces Peer-Reviewed Publication of MODERATO II Study Results Showing a Statistically Significant Reduction in Blood Pressure in Pacemaker-Indicated Patients Treated with BackBeat Cardiac Neuromodulation Therapy

Together, the companies plan to initiate a U.S. pivotal trial for the use of Virtue SAB in the treatment of coronary in-stent restenosis in 2021 which will be the first in a series of pivotal trials aimed at achieving regulatory approvals in multiple indications worldwide. ...

ByOrchestra BioMed, Inc.


Orchestra BioMed Announces Clinical Data Demonstrating a Significant and Sustained Reduction in Blood Pressure in MODERATO II Control Patients After Crossover to BackBeat Cardiac Neuromodulation Therapy

Orchestra BioMed Announces Clinical Data Demonstrating a Significant and Sustained Reduction in Blood Pressure in MODERATO II Control Patients After Crossover to BackBeat Cardiac Neuromodulation Therapy

Together, the companies plan to initiate a U.S. pivotal trial for the use of Virtue SAB in the treatment of coronary in-stent restenosis in 2021 which will be the first in a series of pivotal trials aimed at achieving regulatory approvals in multiple indications worldwide. ...

ByOrchestra BioMed, Inc.


Orchestra BioMed Announces Clinical Data Showing Significant and Sustained Reduction in Systolic Blood Pressure Out to Two Years with BackBeat Cardiac Neuromodulation Therapy

Orchestra BioMed Announces Clinical Data Showing Significant and Sustained Reduction in Systolic Blood Pressure Out to Two Years with BackBeat Cardiac Neuromodulation Therapy

Together, the companies plan to initiate a U.S. pivotal trial for the use of Virtue SAB in the treatment of coronary in-stent restenosis in 2021 which will be the first in a series of pivotal trials aimed at achieving regulatory approvals in multiple indications worldwide. ...

ByOrchestra BioMed, Inc.


ELIXIR MEDICAL EXPANDS BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

ELIXIR MEDICAL EXPANDS BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

Nakamura M, Yock PG, Bonneau HN, et al. Impact of peri-stent remodeling on restenosis: a volumetric intravascular ultrasound study. ...

ByElixir Medical Corporation


B. Braun Interventional Systems Inc., an Affiliate of B. Braun Medical Inc., and Infraredx, a Nipro Company, Announce Strategic U.S. Collaboration to Execute the IDE Clinical Trial for the SeQuent Please ReX Drug Coated PTCA Balloon Catheter

B. Braun Interventional Systems Inc., an Affiliate of B. Braun Medical Inc., and Infraredx, a Nipro Company, Announce Strategic U.S. Collaboration to Execute the IDE Clinical Trial for the SeQuent Please ReX Drug Coated PTCA Balloon Catheter

The companies are ideally positioned to leverage shared resources to accelerate the initiation of the U.S. clinical trial of the SeQuent Please ReX to study the treatment of coronary in-stent restenosis (ISR), which is defined as the gradual re-narrowing of a coronary artery following stent implantation. Despite a significant reduction in ISR ...

ByInfraredx, Inc.


ELIXIR MEDICAL ANNOUNCES COMMENCEMENT OF INFINITY-SWEDEHEART RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

ELIXIR MEDICAL ANNOUNCES COMMENCEMENT OF INFINITY-SWEDEHEART RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

JAMA Cardiol.2019;4(12):1261–1269. doi:10.1001/jamacardio.2019.4101 Nakamura M, Yock PG, Bonneau HN, et al. Impact of peri-stent remodeling on restenosis: a volumetric intravascular ultrasound study. ...

ByElixir Medical Corporation


ELIXIR MEDICAL ANNOUNCES FIRST PATIENT TREATED IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

ELIXIR MEDICAL ANNOUNCES FIRST PATIENT TREATED IN BIOADAPTOR RANDOMIZED CONTROLLED TRIAL OF DYNAMX CORONARY BIOADAPTOR SYSTEM

JAMA Cardiol.2019;4(12):1261–1269. doi:10.1001/jamacardio.2019.4101 Nakamura M, Yock PG, Bonneau HN, et al. Impact of peri-stent remodeling on restenosis: a volumetric intravascular ultrasound study. ...

ByElixir Medical Corporation


Orchestra BioMed Enhances Management Team with Appointment of Regulatory Affairs and Combination Product Expert Bob Laughner as Vice President, Regulatory Affairs

Orchestra BioMed Enhances Management Team with Appointment of Regulatory Affairs and Combination Product Expert Bob Laughner as Vice President, Regulatory Affairs

Together, the companies plan to initiate a U.S. pivotal trial for the use of Virtue SAB in the treatment of coronary in-stent restenosis in 2020 which will be the first in a series of pivotal trials aimed at achieving regulatory approvals in multiple indications worldwide. ...

ByOrchestra BioMed, Inc.


Orchestra BioMed Secures $20 Million Financing Facility from Silicon Valley Bank

Orchestra BioMed Secures $20 Million Financing Facility from Silicon Valley Bank

Food and Drug Administration (FDA) granted Virtue SEB Breakthrough Designations for the treatment of coronary in-stent restenosis and below-the-knee peripheral artery disease. In September 2019, Orchestra BioMed announced CE mark approval for its Moderato® implantable pulse generator system that delivers BackBeat Cardiac Neuromodulation Therapy™ ...

ByOrchestra BioMed, Inc.


Orchestra BioMed to Present at the Innovation in Cardiovascular Interventions Meeting and the CSI Focus D-HF Congress

Orchestra BioMed to Present at the Innovation in Cardiovascular Interventions Meeting and the CSI Focus D-HF Congress

The oral presentations will feature the Virtue® Sirolimus-Eluting Balloon which has Breakthrough Device Designation from the U.S Food and Drug Administration for the treatment of below-the-knee disease and coronary in-stent restenosis, for which the Company has a global strategic partnership with Terumo Corporation. ...

ByOrchestra BioMed, Inc.


Imperial Innovations Set to Increase Investment in Veryan Medical

Imperial Innovations Set to Increase Investment in Veryan Medical

No stent fractures were reported in either treatment group. The 24-month results now released confirm this positive trend and suggest a tangible advantage for the 3D helical stent over current market-leading stents. ...

ByVeryan Medical Ltd.

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