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Ce Marked Implant Articles & Analysis: Older

7 news found

Berlin Heart Received CE Mark and Announces First Implantation of the Latest Cannula Generation to Treat Heart Patients Waiting for a Donor Heart

Berlin Heart Received CE Mark and Announces First Implantation of the Latest Cannula Generation to Treat Heart Patients Waiting for a Donor Heart

Berlin, September 2021: Berlin Heart today announces the CE mark and first implantation of an innovative outflow cannula for mechanical circulatory support with the paracorporeal pulsatile EXCOR® ventricular assist device. ...

ByBerlin Heart GmbH


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

The data demonstrated that BackBeat Cardiac Neuromodulation Therapy™ (CNT™), a programmable and adjustable bioelectronic therapy delivered via an active implantable cardiac pulse generator, significantly reduced 24-hour ambulatory systolic blood pressure (aSBP) in patients with persistent hypertension and a clinical indication for a pacemaker. ...

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

About BackBeat CNT BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment designed to immediately, substantially, and persistently lower blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra BioMed’s CE Mark-approved Moderato® implantable pulse generator system ...

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

ISH patients treated with BackBeat CNT demonstrated a significant reduction in oSBP of 10.6±11.1 mmHg and 14.2±20.5 mmHg (p About BackBeat CNT BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment that immediately, substantially and persistently lowers blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra ...

ByOrchestra BioMed, Inc.


KiOmed Pharma obtains CE mark and signs a License and Supply Agreement

KiOmed Pharma obtains CE mark and signs a License and Supply Agreement

KiOmed Pharma announces the granting of the CE mark for its first implantable product intended to treat osteoarthritis symptoms and the signing of a License and Supply Agreement with TRB Chemedica, a leading pharmaceutical and biotechnology company. KiOmed Pharma announces the granting of the CE mark for its ...

ByKiOmed Pharma


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

About BackBeat CNT™ BackBeat CNT, a flagship therapy of Orchestra BioMed, is a bioelectronic treatment that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the Autonomic Nervous System (ANS). Orchestra BioMed’s CE Mark-approved Moderato® implantable pulse generator system ...

ByOrchestra BioMed, Inc.


Orchestra BioMed Announces Late-Breaking Clinical Results Showing BackBeat Cardiac Neuromodulation Therapy Drives Significant Reduction in Systolic Blood Pressure

Orchestra BioMed Announces Late-Breaking Clinical Results Showing BackBeat Cardiac Neuromodulation Therapy Drives Significant Reduction in Systolic Blood Pressure

” All patients enrolled in the MODERATO II study, a European prospective, multi-center, double-blind, randomized study of BackBeat CNT vs. control in 47 patients with persistent hypertension (ASBP ≥130 mmHg and office systolic blood pressure (OSBP) ≥ 140 mmHg) despite one or more anti-hypertensive medications and a pacemaker indication, were implanted with Orchestra ...

ByOrchestra BioMed, Inc.

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