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Patient Isolation Articles & Analysis

13 news found

Santa Barbara Cottage Hospital Enhances Maternal and Fetal Safety with Go-Live of PeriGen’s PeriWatch Vigilance

Santa Barbara Cottage Hospital Enhances Maternal and Fetal Safety with Go-Live of PeriGen’s PeriWatch Vigilance

Its HUB offers a consolidated view of all patients during the birthing process that helps improve acuity awareness. ...

ByPeriGen, Inc.


FDA Approved Second Phase of ASCENT ASD

FDA Approved Second Phase of ASCENT ASD

The prospective, single-arm study is evaluating the safety and efficacy of the reSept™ ASD Occluder, the first occluder with a metal-free, bioresorbable frame, for the treatment of patients with clinically significant, isolated ASDs. Primary endpoints will be compared with established performance goals for previously FDA-approved transcatheter ASD ...

ByatHeart Medical


atHeart Medical Receives FDA Approval for the Second Phase of the ASCENT ASD U.S. IDE Trial

atHeart Medical Receives FDA Approval for the Second Phase of the ASCENT ASD U.S. IDE Trial

The prospective, single-arm study is evaluating the safety and efficacy of the reSept™ ASD Occluder, the first occluder with a metal-free, bioresorbable frame, for the treatment of patients with clinically significant, isolated ASDs. Primary endpoints will be compared with established performance goals for previously FDA-approved transcatheter ASD ...

ByatHeart Medical


Orchestra BioMed Announces Presentations at TCT 2021 of Positive Long-Term Clinical Results from the MODERATO II Study Showing the Significant Clinical Impact of BackBeat CNT on Isolated Systolic Hypertension and Pulse Pressure

Orchestra BioMed Announces Presentations at TCT 2021 of Positive Long-Term Clinical Results from the MODERATO II Study Showing the Significant Clinical Impact of BackBeat CNT on Isolated Systolic Hypertension and Pulse Pressure

Patients with Isolated Systolic Hypertension (ISH) treated with BackBeat CNT experienced clinically meaningful and statistically significant reductions of 7.4 mmHg in ambulatory systolic blood pressure and 9.4 mmHg in ambulatory Pulse Pressure at 6 months compared to controls. ...

ByOrchestra BioMed, Inc.


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 average age of the study population was 74 years, which is significantly older than patients generally enrolled in hypertension studies. There was also a higher prevalence of comorbid conditions in the study population and 81% of enrolled patients had isolated systolic hypertension (ISH), a more dangerous and difficult to treat form of ...

ByOrchestra BioMed, Inc.


Galaxy Medical Releases ECLIPSE-AF Remapping Data at Stanford Biodesign Retreat and Update on System Interoperability

Galaxy Medical Releases ECLIPSE-AF Remapping Data at Stanford Biodesign Retreat and Update on System Interoperability

SAN CARLOS, California, July 28, 2021 — Galaxy Medical announced today that the ECLIPSE-AF 90-day remapping data, presented at the Stanford BioDesign New Arrhythmia Technologies retreat, demonstrated durable lesions and chronic pulmonary vein isolation (PVI). Also, the company has recently treated patients in the same study using CE-Marked catheters and ...

ByGalvanize Therapeutics, Inc.


First Five Patients Successfully Treated with atHeart Medical’s Novel reSept Atrial Septal Defect Occluder in U.S. IDE Pivotal Trial

First Five Patients Successfully Treated with atHeart Medical’s Novel reSept Atrial Septal Defect Occluder in U.S. IDE Pivotal Trial

atHeart Medical, a medical device company dedicated to establishing the new standard of care for closure of atrial septal defects (ASD), today announced the successful treatment of the first five patients in its ASCENT ASD U.S. Investigational Device Exemption (IDE) pivotal trial. This study, the company’s first in the US, will evaluate the safety and efficacy of the reSept ASD Occluder. ...

ByatHeart Medical


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

Clinically meaningful and statistically significant reduction of 16.6 mmHg in systolic blood pressure out to two years 88% of the treated patients had isolated systolic hypertension (ISH) 70.6% of all treated patients and 80% of treated ISH patients had their blood pressure under control at 24 months Orchestra ...

ByOrchestra BioMed, Inc.


Newly Formed Company, atHeart Medical, Aims to Evolve Septal Closure with the reSept ASD Occlude

Newly Formed Company, atHeart Medical, Aims to Evolve Septal Closure with the reSept ASD Occlude

Initial clinical experience demonstrates longterm clinically effective closure of the ASDs treated with the company’s device.1 “I am excited to lead atHeart Medical and for the potential of our first product, the reSept ASD Occluder, for patients requiring ASD closure,” commented Laurent Grandidier, CEO of atHeart Medical. ...

ByatHeart Medical


Velano Vascular Makes Streamlined Virtual Training Tools Available to U.S. Hospitals to Aid in the COVID-19 Response

Velano Vascular Makes Streamlined Virtual Training Tools Available to U.S. Hospitals to Aid in the COVID-19 Response

Since the outbreak of COVID-19, other hospitals have adopted Velano’s PIVO device with COVID-19 suspected or infected patients to help: Enable RN staff, who are already in the patient’s room, to effectively and easily draw high quality lab samples – without requiring additional practitioners to enter COVID-19 rooms; Enforce social distancing ...

ByVelano Vascular


Infection transmission prevention and control of Coronavirus (COVID-19) made possible through Genano Air Decontamination Units

Infection transmission prevention and control of Coronavirus (COVID-19) made possible through Genano Air Decontamination Units

But in the case of the recent Coronavirus (COVID-19) outbreak early detection and isolation of potentially infectious patients is essential to prevent unnecessary exposures among patients, healthcare personnel, and visitors to a healthcare facility. According to CDC and WHO, besides other infection prevention protocols/precautions the following ...

ByGenano Industrial Air Purification Solutions - Genano Ltd.


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

Following a 30-day run-in period during which patients received only standard pacing along with anti-hypertensive medications, patients who met follow-up screening criteria for daytime ASBP, were randomized to BackBeat CNT or control groups. ...

ByOrchestra BioMed, Inc.


Sentara Leigh and Sentara Virginia Beach General Hospitals are First in the World to Receive Center of Excellence Designation for Managing Infection Risk

Sentara Leigh and Sentara Virginia Beach General Hospitals are First in the World to Receive Center of Excellence Designation for Managing Infection Risk

The new Certification comes at a time when hospitals are grappling with the rising costs – both in terms of patient outcomes and funding – of healthcare associated infections and emerging pandemic risks. ...

ByDNV GL - Business Assurance North America

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