Tag: Medtronic
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...
ABRE subanalysis highlights obesity ‘paradox’ in post-venous stenting outcomes
Results from a subset analysis of the ABRE study have shown that patients in three out of the six World Health Organisation (WHO) body...
Two-year BIOPACT randomised controlled trial analysis demonstrates “persistent excellence” for low-profile...
Biotronik has announced the presentation of two-year results from the investigator-initiated BIOPACT randomised controlled trial (RCT) by principal investigator Koen Deloose (AZ Sint-Blasius Hospital,...
Amazon executive joins Medtronic to spearhead development in robotics and implantables
Medtronic has announced that Ken Washington has been appointed chief technology and innovation officer.
Washington joins Medtronic from Amazon where he served as vice president...
BIOPACT RCT suggests Passeo-18 non-inferior to IN.PACT Admiral DCB
Koen Deloose (Dendermonde, Belgium) talks to Vascular News about the key one-year data from the BIOPACT randomised controlled non-inferiority trial, which evaluated the safety...
Roundtable: Will latest IN.PACT AV Access data impact practice and can...
NOTE: This video is ONLY available to watch in selected countries and geographies
In this Vascular News roundtable, Andrew Holden (moderator; Auckland, New Zealand) is joined...
Medtronic announces first enrolment in head-to-head randomised trail evaluating durability of...
Medtronic has announced the first patient enrolment in the ADVANCE Trial, a head-to-head randomised controlled trial of two leading aortic stent graft systems, the...
Interventional News’ top 10 most popular stories of October 2022
Interventional News’ most popular content last month featured a report on the need for greater interventional radiology (IR) service coverage in rural areas of...
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...
ABRE clinical study 36-month data show sustained effectiveness of Abre venous...
Medtronic has announced the 36-month final results from the ABRE clinical study. The purpose of the ABRE clinical study was to evaluate the safety...
Medtronic receives CE mark for the first balloon-expandable covered stent indicated...
Medtronic announced that it has recently received CE mark for its Radiant balloon-expandable covered stent, the first and currently, only, covered stent indicated for...
Medtronic gains FDA approval for IN.PACT 018 DCB
Medtronic has announced approval from the US Food and Drug Administration (FDA) for the IN.PACT 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a...
Interventional News’ top 10 most read articles of April 2022
A report from the American Venous Forum (AVF) 2022 meeting (23–26 February, Orlando, USA) on the comparative merits and demerits of dedicated and non-dedicated...
First time data release: View the full IN.PACT AV Access trial...
NOTE: This video is ONLY available to watch in selected countries and geographies
In a late-breaking Podium 1st presentation at the 2022 Charing Cross...
IN.PACT AV drug-coated balloon first and only to show sustained and...
Medtronic announced new randomised controlled data demonstrating the sustained and superior performance of IN.PACT AV drug-coated balloon (DCB) compared to percutaneous transluminal angioplasty (PTA)...
Medtronic names Laura Mauri as new chief scientific, medical and regulatory...
Medtronic has announced that Laura Mauri has been appointed as the company’s chief scientific, medical and regulatory officer. This appointment adds to Mauri's prior responsibilities...
Cydar Medical announces strategic collaboration with Medtronic
Cydar Medical recently announced it has entered a strategic collaboration with Medtronic. Under the pilot arrangement, Cydar’s EV Maps software will be introduced to...
Medtronic issues voluntary recall for subset of IN.PACT Admiral and IN.PACT...
Medtronic recently voluntarily recalled a subset of its IN.PACT Admiral and IN.PACT AV paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheters due to the potential...
Medtronic recalls HawkOne directional atherectomy system due to risk of tip...
According to the US Food and Drug Administration (FDA), Medtronic is recalling its HawkOne directional atherectomy system.
The FDA has identified the recall as a...
IN.PACT Admiral DCB performs well across wide range of clinical and...
In a pooled analysis of the predictors of drug-coated balloon (DCB) effectiveness, the IN.PACT Admiral DCB (Medtronic) performed well across a broad range of...
Benefits of percutaneous fistula creation further bolstered by five-year Ellipsys data
The Ellipsys vascular access system (Avenu Medical/Medtronic) can be used to easily and safely create durable percutaneous arteriovenous fistulas (pAVFs) for haemodialysis—with new, long-term...
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...
VIVA 2021: IN.PACT Admiral DCB found to provide “high five-year freedom...
Real-world data drawn from the IN.PACT Global study looking at five-year freedom from clinically-driven target lesion revascularisation (TLR) among prespecified chronic total occlusion (CTO),...
Medtronic receives CE mark approval for radial artery access portfolio
Medtronic today announced it has received CE mark approval for its radial artery access portfolio, which includes the Rist radial access selective catheter and the Rist...
BIOPACT head-to-head non-inferiority randomised controlled trial completes enrolment
Biotronik is proud to announce the completion of enrolment of the investigator-initiated BIOPACT randomised controlled trial (RCT). This non-inferiority study evaluates the safety and...
Medtronic receives CE mark for 200mm and 250mm IN.PACT Admiral DCBs
Medtronic has announced the European launch of the 200mm and 250mm IN.PACT Admiral drug-coated balloons (DCBs) following CE mark approval. The product is intended...
Medtronic receives FDA breakthrough designation for the Emprint ablation catheter kit
The US Food and Drug Administration (FDA) have granted breakthrough device designation for the Emprint ablation catheter kit (Medtronic). This is an investigational device...
More mixed results for DCBs in AV access maintenance as evidence...
Additional randomised controlled data regarding the effectiveness of drug-coated balloons (DCBs) in maintaining arteriovenous (AV) access offers new evidence, but it is freighted with...
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...
Two-year IN.PACT AV Access results presented at CX 2021
Medtronic recently announced the safety and effectiveness results through 24 months for the IN.PACT AV Access clinical study. The data, which were presented virtually...
Swift, significant, sustained pain relief with the OsteoCool RF ablation system
This educational supplement is sponsored by Medtronic.
In this supplement:
Spotlight on the OsteoCool RF ablation system
Watching a “small Canadian invention” transform cancer care:...
RFA with OsteoCool leads to “rapid and sustained” pain relief in...
Treating patients with metastatic bone disease by radiofrequency ablation (RFA) using the OsteoCool system (Medtronic) results in rapid and statistically significant improvement in pain...
Medtronic launches IN.PACT AV DCB in Japan for patients undergoing haemodialysis
Medtronic has announced the launch of IN.PACT AV drug-coated balloon (DCB) in Japan. IN.PACT AV DCB is indicated for the treatment of obstructive lesions...
Medtronic to acquire Avenu Medical
Medtronic today announced the planned acquisition of Avenu Medical, a medical device company focused on the endovascular creation of arteriovenous (AV) fistulae for patients...
TOBA III clinical trial results published in the Journal of Vascular...
Intact Vascular has announced the peer-reviewed publication of its Tack optimised balloon angioplasty (TOBA) III 12-month clinical trial results in the Journal of Vascular Surgery.
The multi-centre, single-arm,...
Medtronic issues urgent field safety notice for some Pipeline Flex embolization...
Medtronic has issued an urgent field safety notice to warn on specific production lots of its Pipeline Flex embolization devices due to the potential...
LINC 2020: Real-world evidence shows no increased mortality signal with paclitaxel-coated...
Dierk Scheinert (Leipzig, Germany) moderates a panel with Eva Freisinger (Münster, Germany) and Thomas Zeller (Bad Krozingen, Germany) to discuss the developments over the...
BIBA Briefings: FDA approval of IN.PACT AV is a boon for...
Last month (November), the FDA approved Medtronic’s paclitaxel-coated balloon IN.PACT AV for the management of failing arteriovenous fistulae (AVF). Approval for the device was based...
Medtronic DCB receives US FDA approval to treat arteriovenous fistula lesions
Medtronic today announced US Food and Drug Administration (FDA) approval of the IN.PACT AV drug-coated balloon (DCB), a paclitaxel-coated balloon indicated for the treatment...
Medtronic receives FDA breakthrough device designation for its Valiant Navion LSA...
Medtronic today announced it has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Valiant TAAA stent graft system...
Omar Ishrak to step down as Medtronic CEO next year
Omar Ishrak, Medtronic’s chairman and CEO is to retire on 26 April 2020, following the end of the company’s current fiscal year. Also, the...
IN.PACT AV access trial meets primary safety and effectiveness endpoints
Medtronic has announced the first-ever results from the IN.PACT AV access clinical study comparing the investigational IN.PACT AV drug-coated balloon (DCB) to percutaneous transluminal...
UK consensus statement on renal denervation “strongly encourages” clinicians to tell...
In a new consensus statement, the Joint UK Societies (JUKS)—which includes the British Society of Interventional Radiology—say that the evidence for renal denervation is “insufficient”...
Medtronic statement regarding updated FDA letter to healthcare providers on paclitaxel...
Medtronic has issued the following statement regarding the US Food and Drug Administration’s (FDA) updated letter to healthcare providers for paclitaxel-devices in patients with...
Road “wide open” for Osteocool radiofrequency ablation in patients with painful...
Jason Levy (Atlanta, USA) and Sandeep Bagla (Virginia, USA) talk to Interventional News about preliminary results from the ongoing OPuS One study. The OPuS...
BIOPACT-RCT set to compare Passeo-18 Lux and IN.PACT Admiral DCBs in...
iD3 Medical has announced that it has received approval in Belgium to initiate a randomised controlled trial, BIOPACT-RCT: a physician-initiated multicentre trial evaluating the...
CX 2019: Evidence supports safety of paclitaxel-coated devices
At the Charing Cross International Symposium, Gary Ansel (Columbus, Ohio) moderates a global panel that includes Thomas Albrecht (Berlin, Germany), Peter Schneider (San Francisco,...
Two companies with paclitaxel-coated devices issue corrections to published data
Both Medtronic and Cook Medical have issued corrections to published data regarding the safety of their paclitaxel-coated devices. While Medtronic have revised IN-PACT post-market...
Medtronic revises IN.PACT post-market study data due to programming error, but...
Medtronic has issued the following statement regarding revised clinical study data:
Recently, Medtronic became aware of a programming error in the clinical data reporting isolated...
Patient-level analysis shows no correlation between paclitaxel and mortality—reactions from LINC
Renowned experts expressed confidence in the continued use of paclitaxel-coated devices after independent patient-level data presented at LINC 2019 did not show correlation between...
Three-year Japanese results show IN.PACT Admiral DCB offers “consistent and durable”...
The IN.PACT Admiral drug-coated balloon (DCB; Medtronic) exhibits a consistent and durable treatment effect in “a more complex patient demographic than typically seen in...
Medtronic and Boston Scientific stand by paclitaxel devices despite Katsanos’ critical...
Speaking to investors at the JP Morgan healthcare conference in San Francisco, executives from Medtronic and Boston Scientific said their data do not show...
Revised safety analysis of Medtronic’s IN.PACT Admiral DCB published in JACC
Medtronic has issued the following statement regarding revised clinical study data:
On 15 February, 2019, Medtronic issued a statement regarding a programming error in the...
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...
IN.PACT SFA Trial five-year data and Total IN.PACT All-Subjects analysis presented...
The five-year and final results from the pivotal IN.PACT SFA Trial and one-year all-subjects results from the Total IN.PACT Pooled Analysis of the IN.PACT...
Valiant Navion thoracic stent graft receives FDA approval
The US Food and Drug Administration (FDA) has approved Valiant Navion thoracic stent graft system (Medtronic) for the minimally invasive repair of all lesions...
New renal denervation data show significant blood pressure reduction in patients...
Late-breaking SPYRAL HTN-ON MED study at EuroPCR indicates renal denervation lowers blood pressure in hypertensive patients in presence of blood pressure medication.
Medtronic has announced...
IN.PACT Admiral DCB receives FDA approval for long SFA lesions
Medtronic has announced that it has received US Food and Drug Administration (FDA) approval for the IN.PACT Admiral drug-coated balloon (DCB) to treat long superficial...
New products showcased at SIR 2018
There were several devices in the New Product Showcase at the Society of Interventional Radiology's Annual Scientific Meeting in Los Angeles, USA. Among these...
First data from head-to-head comparison of Ranger and IN.PACT drug-coated balloons...
Early data from the first randomised controlled trial to compare two drug-coated balloons (DCBs) suggest that the primary patency obtained with the Ranger DCB...
IDE study to evaluate Abre Venous Self-Expanding Stent in patients with...
Medtronic has announced the initiation of its investigational device exemption (IDE) study for the Abre venous self-expanding stent system. The ABRE IDE Study will...
ENCHANT will evaluate ChEVAR technique with Endurant II/IIs stent graft system
The post-market, non-interventional, multicentre, non-randomised, single-arm study will enroll approximately 150 patients across 25 sites in Europe and Russia, and will evaluate the safety...
Medtronic gets US FDA clearance for Riptide aspiration system
The Riptide aspiration system is intended for use in the revascularisation of patients with acute ischaemic stroke secondary to intracranial large vessel occlusive disease...
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...
First patient enrolled in IN.PACT arteriovenous access drug-coated balloon study
The US FDA has approved the investigational device exemption (IDE) study to evaluate the safety and efficacy of IN.PACT AV access drug-coated balloon as...
Medtronic gets option to purchase QT Vascular’s non-drug coated Chocolate PTA
QT Vascular has announced that it has entered into an asset purchase option agreement with Medtronic, for the acquisition of the non-drug coated Chocolate...
OsteoCool RF ablation system gets expanded indication for palliative treatment of...
Medtronic has announced that the US FDA has cleared an expanded indication for the OsteoCool radiofrequency (RF) ablation system.
Originally cleared for use in the...
US FDA grants Medtronic investigational device exemption for new In.Pact Admiral...
Medtronic has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a study of the In.Pact Admiral...
Results from Asia and Belgium demonstrate consistent results from Medtronic In.Pact...
New data presented at the 2017 Leipzig Interventional Course (LINC) have demonstrated strong efficacy and consistent outcomes for Medtronic’s In.Pact Admiral drug-coated balloon across...
Medtronic receives CE mark for lower-profile HawkOne directional atherectomy system
Medtronic has been granted CE mark approval for the HawkOne directional atherectomy system in a lower profile size for treating patients with peripheral artery...
Medtronic gets FDA clearance of new lower profile HawkOne 6F directional...
Medtronic has received US FDA 510(k) clearance for the HawkOne directional atherectomy system in a new size for treating patients with peripheral artery disease....
Medtronic receives US FDA clearance for TrailBlazer angled peripheral support catheter
Medtronic has announced that the US FDA has cleared the TrailBlazer angled support catheter for use in the peripheral vascular system. Support catheters such...
