Tag: renal denervation
CMS launches review of coverage for renal denervation
The Centers for Medicare & Medicaid Services (CMS) is opening a national coverage analysis (NCA) on renal denervation, with a view to reviewing and...
CMS grants transitional pass-through payment for Medtronic’s Symplicity Spyral and Recor’s...
The Centers for Medicare and Medicaid Services (CMS) has granted transitional pass-through (TPT) payment for Medtronic's Symplicity Spyral renal denervation (RDN) catheter and Recor...
TCT 2024: Two-year SPYRAL HTN-ON MED show “consistent” effect of renal...
Medtronic has announced new, long-term data from the SPYRAL HTN-ON MED clinical trial that showed subjects who underwent radiofrequency renal denervation with the Symplicity...
First patients treated in US GPS study of Paradise renal denervation...
The first patients in the USA have been treated in Recor Medical’s Global Paradise System US Post Approval Study (US GPS), a real-world study...
Study of TIVUS renal denervation system for hypertension treatment completes enrolment
The REDUCED-1 study, a US Food and Drug Administration (FDA) investigational device exemption (IDE)-approved pilot study of the treatment of hypertension with the proprietary...
FDA panel votes favourably on safety and efficacy of Paradise renal...
The US Food and Drug Administration (FDA) Circulatory Systems Devices Panel of the Medical Devices Advisory Committee yesterday (22 August) voted that there is...
Results on ReCor Medical’s Paradise ultrasound renal denervation system published in...
ReCor Medical and its parent company, Otsuka Medical Devices, recently announced that primary endpoint results from the RADIANCE II pivotal trial were published in...
ESC and EAPCI publish renal denervation consensus statement
Renal denervation represents another treatment option in patients with uncontrolled resistant hypertension and may be used in selected patients deemed intolerant to antihypertensive drugs.
These...
Vascular News’ top 10 most popular stories of January 2023
January's top 10 highlights an individual patient data meta-analysis on the safety of carotid endarterectomy in the elderly and a new randomised trial on...
ReCor appoints Lara Barghout to lead commercialisation of Paradise renal denervation...
ReCor Medical and its parent company Otsuka Medical Devices have announced the appointment of Lara Barghout as president and chief executive officer of ReCor.
Barghout...
Otsuka Medical Devices and ReCor Medical submit premarket approval of Paradise...
Otsuka Medical Devices and ReCor Medical, a subsidiary of Otsuka, announce the filing of the premarket approval (PMA) application to the US Food and Drug...
ReCor Medical announces consistent reduction of blood pressure in pooled analysis...
ReCor Medical and its parent company, Otsuka Medical Devices, announced consistent and significant blood pressure-lowering results across a range of patients with uncontrolled hypertension,...
SPYRAL HTN-ON MED study demonstrates meaningful clinical benefits consistent with other...
Medtronic has announced the six-month results from the full cohort of the SPYRAL HTN-ON MED clinical trial. The late-breaking data were presented at the...
TCT 2022 hears “important data” from renal denervation trials
Findings from the RADIANCE II randomised pivotal trial, presented at the 2022 Transcatheter Cardiovascular Therapeutics meeting (TCT, 16–19 September, Boston, USA), “confirm that ultrasound...
Ultrasound renal denervation meets primary efficacy endpoint in RADIANCE II study
ReCor Medical and Otsuka Medical Devices have announced that the RADIANCE II US Food and Drug Administration (FDA) investigational device exemption (IDE) pivotal trial...
SoniVie announces successful procedure with Tivus system on first patient enrolled...
SoniVie today announced that on 30 May this year the first patient was treated with its renal artery denervation Tivus therapeutic intravascular ultrasound technology, as...
SoniVie receives FDA IDE approval for pilot study to treat hypertension...
SoniVie recently announced that on 5 May 2022 the US Food and Drug Administration (FDA) granted investigational device exemption (IDE) approval for its REDUCED1...
EuroPCR 2022: Studies underscore potential of renal denervation as an adjunctive...
Late-breaking trial data presented at EuroPCR 2022 (17–20 May, Paris, France) underscore the potential of renal denervation as an adjunctive therapy to treat hypertension,...
Medtronic unveils data on hypertension treatment preferences, launches SPYRAL AFFIRM study
Medtronic today announced findings from a new study of patient preferences for the treatment of hypertension. The findings are set to be presented during...
Vascular News’ top 10 most popular stories of September 2021
September's top 10 features five-year ACST-2 results, a new tool to assess amputation risk following popliteal vascular injury, and an interview highlighting the questions...
EuroPCR 2021: Late-breaking data demonstrate long-term benefits of Medtronic radiofrequency renal...
Medtronic today announced new clinical data from the Global SYMPLICITY registry (GSR) indicating that renal denervation with the Medtronic Symplicity renal denervation system was...
Global SYMPLICITY Registry shows renal denervation lowered blood pressure in patients...
Medtronic has reported new data from the Global SYMPLICITY Registry (GSR), which showed that renal denervation (RDN) with the Medtronic Symplicity renal denervation system...
Virtual ACC: Renal denervation bests sham control to safely lower blood...
Three months after undergoing renal denervation, patients with untreated high blood pressure had statistically significant reductions in average blood pressure over 24 hours compared...
TARGET BP I trial enrols its first patient
The first patient has been randomised in the TARGET BP I trial at the Piedmont Heart Institute in Atlanta, USA, to investigate the use...
EuroPCR 2019: Renal denervation linked to reduction in subclinical atrial fibrillation
Data presented at EuroPCR today indicates that renal denervation with the Symplicity system (Medtronic) is associated with a reduction in subclinical atrial fibrillation in...
The resurgence of renal denervation
More than ever before, arterial hypertension represents one of the greatest health threats and challenges for both patients and treating physicians. With the new...
US FDA approve new study of Medtronic’s Spyral renal denervation system
The FDA have given Medtronic approval to begin a clinical trial to evaluate the Symplicity Spyral renal denervation system in patients with hypertension who...
Otsuka Medical Devices, Otsuak Holdings, and ReCor Medical to merge
Otsuka Holdings, Otsuka Medical Devices, and ReCor Medical have signed a merger agreement pursuant to which Otsuka Holdings will acquire the remaining shares in...
FDA approves RADIANCE-II study of Paradise ultrasound denervation system
The RADIANCE-II study of the Paradise Ultrasound Denervation System (ReCor Medical) for the treatment of hypertension has been approved by the US Food &...
ReCor Medical completes RADIANCE-HTN SOLO hypertension study
ReCor Medical announced today randomisation of its 146th, and final, subject in the SOLO cohort of its RADIANCE-HTN study. RADIANCE-HTN, ReCor's study of its Paradise...
From SYMPLICITY HTN-1 to SPYRAL HTN-OFF MED: The story of renal...
It is now almost a decade since the first patient underwent catheter-based renal denervation as a participant in a safety and proof-of concept study...
ESC 2017: MobiusHD implant shown to reduce resistant hypertension
The European results of the first-in-human trial of Vascular Dynamics’ MobiusHD implant indicate that the device is associated with a reduction in 24-hour ambulatory...
