Vascular News

02/07/2024

FORS-powered LumiGuide has “gold-standard” potential for 3D device guidance without radiation

A new technology is set to change the endovascular game by offering 3D, full-colour guidance to replace the 2D, greyscale standard-of-care. The result? Increased visualisation without the use of fluoroscopy. This is one of the key messages to have emerged from a roundtable discussion at the recent Charing Cross (CX) International Symposium (23–25 April, London, UK) on complex aortic procedures, Fiber Optic RealShape (FORS) technology, and the latest from Philips—FORS-powered LumiGuide.

The CX discussion saw aortic experts Bijan Modarai (London, UK), Isabelle van Herzeele (Ghent, Belgium) and Laurent Chiche (Paris, France) all share their experience with and expert opinions on Philips’ imaging offering for complex aortic procedures.

The speakers highlighted the issue of increased radiation exposure that is associated with the increased complexity of endovascular cases. The solution that they suggest is the FORS-powered LumiGuide (Philips), which provides 3D device guidance using light that aims to offer better visualisation in full colour, with minimal need for fluoroscopy.



This post is by Philips.

www.philips.com/LumiGuide

Bijan Modarai Isabelle Van Herzeele Laurent Chiche Philips Imaging Atul Gupta, MD

11/06/2024

Vicente Riambau (Barcelona, Spain) describes the unique features and improvements of the iCover balloon expandable covered stent, notably its low profile, radiopaque markers, and total encapsulation with polytetrafluoroethylene (ePTFE), which give the device an edge over its competitors and make it his “first choice.”

Riambau also reflects on how iVascular’s vertical integration, by which the company manufactures all product components such as plastic tubes, balloons and stents, allows freedom from supply chain difficulties. This is important, he says, to maintain high quality for every single step during the manufacture of key parts.

https://vascularnews.com/icovers-radiopaque-markers-and-full-encapsulation-with-small-profiles-help-it-stand-out-from-competitors/

This video is sponsored by
iVascular

04/06/2024

Andrew Holden (Auckland, New Zealand), one of the co-chairs of the Charing Cross (CX) International Symposium, presented the final five-year data on the vital status of patients enrolled in the IN.PACT AV Access pivotal trial in April 2024 as a podium-first presentation. Due to the paclitaxel safety concerns raised, the researchers re-consented patients enrolled in the trial to prolong the follow-up period to establish their long-term vital status.

“The all-cause mortality remains the same out to five years. There is no mortality concern using the IN.PACT [AV] drug-coated balloon (DCB). The long-term durability of this study really shows that the IN.PACT DCB should be the standard of care in maintaining [the] AV [arteriovenous] access circuit,” Holden said, reminding the audience that this is the only randomised, pivotal trial in AV access circuits to demonstrate a consistent and sustained clinical benefit out to three years.

The IN.PACT AV Access randomised controlled trial comparing plain balloon angioplasty with DCB angioplasty in managing stenotic disease in AV access has previously shown significantly improved sustained benefits for end-stage kidney disease patients at the three-year time point. Further research has also demonstrated a cost-effectiveness advantage for healthcare systems in Japan, Korea and the USA, when the device is used.

Watch now: https://vascularnews.com/first-time-presentation-of-in-pact-av-access-five-year-data-lays-paclitaxel-mortality-concerns-to-rest/

This video is sponsored by Medtronic.

27/05/2024

Are you an early bird?🐤

Attend the Annual Meeting in Kraków at a discounted price.

Anticipate controversial debates, our best-selling workshops, and of course, a lot of fun!💃

Hurry, the discount is only available until the 9th of July!

🎟️https://esvs.org/events/annual-meeting/annual-meeting-2024/registration-accomodation/

22/04/2024

We look forward to meeting you at the , from Apr 23-25 in London. Stop by the Teleflex booth n. 107 and join us for our Hands-on training sessions with the advanced pulsatile MANTA simulator and learn how to close arteriotomies as large as 25F OD using MANTA Vascular Closure Device!



https://irc.teleflex.com/manta-emea/

Sponsored by Teleflex

15/04/2024

GREAT BENEFITS THROUGH THE INTERACTION OF ZIEHM VISION RFD HYBRID EDITION AND THERENVA

With its zero room preparation, the comprehensive mobile hybrid solution easily takes your OR to the next level. Plug in your system and start your hybrid procedure.

Visit us at booth #209 and experience the workstation for testing Therenva EndoSize on site.

Take part in our two exciting live workshops:

- “Intraoperative 3D vascular navigation using a complete mobile hybrid solution” - Tuesday, April 23rd

- “From pre-operative sizing to OR with assisted 3D guidance to enhance endovascular procedures - Powered by EndoSize and EndoNaut” - Thursday, April 25th



Sponsored by Ziehm Imaging

09/04/2024

This year marks a significant milestone as BD celebrates 25 years of its Rotarex™S rotational atherothrombectomy system, a journey that started in the Swiss mountains with Immanuel Straub, and has today touched the lives of over 250,000 patients. In this article, Vascular News outlines the heritage and history of the device and presents a case report from Mark Portou (Royal Free Hospital, London, UK) highlighting its continued real-world application and outcomes.

The story of RotarexS begins in the early 1990s, when Immanuel Straub, a Swiss engineer and founder of Straub Medical, teamed up with a medical doctor to create a tool to treat . Straub combined knowledge from Swiss watchmakers (specialists in micro engineering) and Swiss mountain tunnellers (with their ability to break through the toughest materials) and along with his own expertise in creating high-quality and high-durability springs for the car industry, they came up with a concept for the treatment of arterial blockages. This concept became RotarexS.

Read more: https://vascularnews.com/rotarexs-a-25-year-legacy-continues/

Advertorial sponsored by Beckton Dickinson

This year marks a significant milestone as BD celebrates 25 years of its RotarexS rotational atherothrombectomy system.

03/04/2024

In a recent interview, Marie Josee van Rijn from Rotterdam, the Netherlands and Emma Wilton from Oxford, UK, provided insight into the transformative power of interventional approaches in the treatment of DVT. They also set the stage for the upcoming INARI Symposium at CX 2024, where they will focus on the critical importance of clot removal and its profound impact on the lives of patients with iliofemoral DVT.

Both van Rijn and Wilton agree that mechanical thrombectomy has enabled their centers to achieve an optimal patient pathway by providing interventionalists with a wider treatment window. ” It doesn’t really matter if the clot is two, six or eight weeks old, you can still intervene with ClotTriever. If you only had thrombolysis as a treatment option, that would matter and your therapy would fail”.
To learn more about INARI’s Symposium at CX 2024 click here:

https://vascularnews.com/why-treat-dvt-interventionally-what-are-the-major-benefits-of-wall-to-wall-mechanical-thrombectomy-how-does-the-clottriever-system-impact-the-dvt-patient-pathway/

This video was filmed by Inari Medical and is being sponsored for distribution in association with Vascular News, Interventional News and Venous News. Biba Medical bears no responsibility for the assets used in the production of this video.

  In a recent interview, Marie Josee van Rijn from Rotterdam, the Netherlands and Emma Wilton from Oxford, UK, provided insight into the transformative power of interventional approaches in the treatment of DVT. They also set the stage for the upcoming INARI Symposium at CX 2024, where they will fo...

04/01/2024

"Despite significant technological improvements since its inception, endovascular repair of abdominal aortic aneurysms (AAAs) is still associated with some of the same problems we experienced nearly 30 years ago," Michel Reijnen (Arnhem, The Netherlands) remarked at the VEITHsymposium 2023 (14–18 November, New York, USA). One of these issues—and a significant unmet need in the aortic field—is the failure of a AAA to regress post-endovascular aneurysm repair (EVAR).

Reijnen was speaking with Jan Heyligers (Tilburg, The Netherlands) on the benefits of active sac management—specifically technology from Shape Memory Medical—and highlighted new evidence from the AAA-SHAPE study, which they commented might inject some much-needed data into the conversation.
There is evidence to suggest that patients with a shrinking aneurysm do better, Reijnen noted, stressing that the time to make progress in this field is now. “We are at a crossroads,” he said. “We need to add something to our regular EVAR and active sac management—where we fill up the complete sac—which may well be a step forward.”

At VEITH 2023, Reijnen presented some new evidence on active sac management from the AAA-SHAPE early feasibility study, which enrolled 35 patients. He reported no device- or procedure-related major adverse events and “impressive” sac regression results. The technique used in AAA-SHAPE was recently published in the Journal of Vascular Surgery: Cases, Innovations and Techniques, and Reijnen noted that the manuscript on the one-year results has been accepted for publication.

This video is sponsored by Shape Memory Medical.
LIT1170 Rev A

Watch the full video here: https://vascularnews.com/active-sac-management-represents-step-forward-for-evar/

 “Despite significant technological improvements since its inception, endovascular repair of abdominal aortic aneurysms (AAAs) is still associated with some of the same problems we experienced nearly 30 years ago,” Michel Reijnen (Arnhem, The Netherlands) remarked at the VEITHsymposium 2023 (...

14/12/2023

Vascular surgeon Raphael Coscas (Paris, France) and interventional cardiologist, Antoine Sauguet (Toulouse, France) and discuss the design and first results from the RADIANCY premarket clinical study, as well as the advantages of the radial approach at the 2023 Paris Vascular Insights (PVI; 8–10 November, Paris, France).

RADIANCY is a prospective, multicentre, single-arm study, designed to evaluate the safety and efficacy of the S.M.A.R.T. Radianz Vascular stent system when used with the Brite Tip Radianz Guiding sheath and Saberx Radianz PTA dilatation catheter (Cordis) for treatment of iliac and femoropopliteal artery lesions in peripheral arterial disease (PAD) patients via radial artery access. The study enrolled 151 patients at 12 sites across six European countries. The results of the first 100 patients were presented at PVI 2023 by Coscas, who said: “The results were excellent. We had a 98% technical success rate and a very low rate of conversion to femoral access of around 1%. The devices were very safe. We had no device-related complications and no other serious complications; no mortality, stroke, nothing like that. We had a sustained improvement in the quality of life of the patient at 30 days. So, we can say that these preliminary results are really satisfactory.”

Sauguet states that the radial approach has been exported from the cardiology field to the peripheral field and shares tips and tricks to ensure the safe use of the procedure. The duo also discuss how the radial approach has shown no bleeding complications, facilitating early ambulation and discharge and share their hopes for an enlarged portfolio and the availability of other devices that are compatible with a 6Fr sheath for transradial angioplasty.

This video has been sponsored by Cordis.

NOTE: This video is ONLY available to watch in selected countries and geographies

04/12/2023

Daniel Clair (Vanderbilt University Medical Center, Nashville, USA) speaks to Vascular News at this year’s VEITHsymposium (14–18 November, New York, USA) on deep vein arterialisation [DVA] with the LimFlow system (LimFlow). The technology aims to fill a treatment gap for ‘no-option’ chronic limb-threatening ischaemia (CLTI) patients.

New data from PROMISE II show durable outcomes for the LimFlow device—recently approved for use by the US Food and Drug Administration (FDA)—at 12 months. These results build on the six-month data presented last year and recently published in the New England Journal of Medicine.

In this interview, Clair analyses the data further. He considers some key differences between PROMISE I and II, noting the inclusion of patients with end-stage renal disease in the latter, for example. Despite this and other variances, Clair points out, outcomes proved similar across the two trials.

Clair also considers how the PROMISE trials compare to data from Europe. A presentation on data from the ALPS registry featured at VEITHsymposium 2023, in which Clair notes limb salvage rates were “very similar” to those in PROMISE I and PROMISE II, as was amputation-free survival.

In light of these most recent data, Clair outlines what is next for deep vein arterialisation, pointing towards the recently initiated PROMISE III trial.

While these are early days for the technology, Clair is optimistic about the future. “We are doing very well when we compare [DVA with LimFlow] to historical controls,” he remarks, adding that the technology represents “a real advance” for patients with complex CLTI disease.

Watch now: https://vascularnews.com/deep-vein-arterialisation-a-real-advance-for-treatment-of-no-option-clti/

 Daniel Clair (Vanderbilt University Medical Center, Nashville, USA) speaks to Vascular News at this year’s VEITHsymposium (14–18 November, New York, USA) on deep vein arterialisation [DVA] with the LimFlow system (LimFlow). The technology aims to fill a treatment gap for ‘no-option’ chro...

17/10/2023

The EffPac trial was a prospective, multicentre, randomised controlled trial (RCT) that enrolled 171 patients of Rutherford category two to four with medium-length femoropopliteal lesions. Patients were allocated 1:1 to either Luminor drug-coated balloon (DCB) angioplasty or plain balloon angioplasty (POBA). The long-term results showed a high efficacy (fTLR 82.1%) and statistically superior primary patency for Luminor over POBA, and importantly, showed that DCB use resulted in no safety differences between the two groups.

The investigators achieved on-site patient visits in 50% of the recruited patients after five years.

“These data are pretty rare […] and actually after this whole discussion about safety of paclitaxel-coated DCBs, I think [this trial] really adds important data,” Ulf Teichgräber (Jena, Germany) tells Vascular News at the Cardiovascular and Interventional Radiological Society of Europe (CIRSE) 2023 annual meeting.

This video is sponsored by iVascular.

https://vascularnews.com/five-year-rct-data-provide-upbeat-message-on-luminor-paclitaxel-coated-balloons-safety-and-efficacy/

NOTE: This video is ONLY available to watch in selected countries and geographies

05/09/2023

Patient voice central to new trial addressing nerve catheter PLACEMENT in major amputation care

David Bosanquet speaks on the PLACEMENT trial, which addresses the topic of pain control around the time of a major amputation.

01/09/2023

“The median thrombus age of DVT patients treated in our centre is 14 days – say Andrew Wigham from Oxford University Hospitals. – We know that traditional treatment options such as thrombolytics and other thrombectomy devices are less effective once thrombus is more organised. When using the ClotTriever System, we are able to treat those patients effectively”.

Along with the benefits of being able to treat the full chronicity of DVT, Wigham highlights a single-session treatment, lytic-free approach and minimising the hospital length of stay for patients, as the additional advantages of the ClotTriever system.

“We treat more and more young patients with DVT and the fact that we can offer a lytic-free treatment and eliminate bleeding risks related to thrombolytics, makes a huge difference – says Wigham.

Access to the interventional treatment for eligible DVT patients, remains still a challenge due to the lack of awareness, both among referring and treating physicians, of the effective clot removal from the iliac veins. “There are still many patients receiving thrombolysis and although their symptoms are not improving, they don’t get any interventions – says Wigham. – Building dedicated DVT pathways is a crucial task to make sure that the patients receive the right treatment.

To learn more about the ClotTriever system, join the INARI Symposium at CIRSE 2023 where Andrew Wigham and other experts will be discussing a lytic-free thrombectomy as the first choice for both DVT and acute PE (FlowTriever) treatment on Sunday 10th September at 1pm (Auditotium 15).

This video was filmed by Inari Medical and is being sponsored for distribution in association with Vascular News, Interventional News, Venous News and CX Vascular. Biba Medical bears no responsibility for the assets used in the production of this video.

 “The median thrombus age of DVT patients treated in our centre is 14 days – says Dr Andrew Wigham from Oxford University Hospitals. – We know that traditional treatment options such as thrombolytics and other thrombectomy devices are less effective once thrombus is more organised. When usi...

01/09/2023

First US patient enrolled in SOCRATES short neck AAA trial

The first U.S. patient has been treated as part of the SOCRATES trial (Short neck AAA randomized trial—ESAR and FEVAR).

31/08/2023

The benefits of Shockwave Medical’s new Shockwave L6 Peripheral Intravascular Lithotripsy (IVL) catheter—designed for use in large, calcified vessels (available in 8-12 mm diameter sizes), —were highlighted recently during a case-based roundtable discussion at the Society for Vascular Surgery’s 2023 Vascular Annual Meeting (VAM) in National Harbor, Maryland (June 14–17).

Karan Garg (New York City) was joined by Misty Humphries (Sacramento, California) and Mathew Wooster (Charleston, South Carolina) to explore how the new device has changed their practice and treatment approach in larger vessels.

To illustrate use of the device in clinical practice, Humphries shared a case where Shockwave L6 was used to treat a calcified iliac artery to enable delivering of a large bore device. A 73-year-old man presented with a 7cm type 4 thoracoabdominal aneurysm and Humphries noted that physician-modified grafts are often used to treat these patients and that a percutaneous method is preferable, though she stressed that this requires a large device.
One alternative in cases such as this would be using a conduit, although Humphries highlighted that this is far from ideal, citing additional case time and increased blood loss. Essentially, she said, using a conduit makes a case “really challenging”.

For cases such as the one highlighted by Humphries, Garg remarked that the L6 is a “clear improvement” on the Shockwave M5+, an earlier, smaller-diameter device from Shockwave Medical—noting that it can be more effective at treating vessels with larger diameters.

Humphries reported a “great result” from the case using the L6, with the left common iliac (used for access) opened with no remaining stenosis.
Based on her clinical experience, Humphries advised users to oversize the device by 10% for optimal results. “This is not something to be afraid of,” she said, stressing that good wall apposition is key to breaking up calcium.
On a more general note, Garg admitted that while he was a “very slow adopter” of the L6 technology, he now holds the opinion that “once you start using it, you can’t get enough of it,” referencing his use of the technology in tibial vessels. “I find it very effective in that space”.

Similarly, Wooster noted that the L6 has expanded practitioners’ ability to get percutaneous access to the common femoral artery in patients who otherwise would have required a surgical cut-down. In addition, he shared that there are “really strong data” available showing benefit in these patients.

The Shockwave L6 catheter is available in the US-only.
https://vascularnews.com/shockwave-l6-catheter-expands-treatment-options-for-large-vessel-cases/

This video is sponsored by Shockwave Medical.

NOTE: This video is ONLY available to watch in selected countries and geographies

31/08/2023

Curious to learn more about the recent updates on safety and efficacy of paclitaxel use in SFA treatment?

Read the full article: https://vascularnews.com/fda-update-paclitaxel-coated-devices-for-pad-cleared-of-excess-mortality-risk-proven-safe-and-effective/



Sponsored by Boston Scientific

29/08/2023

“A truly novel and potentially groundbreaking treatment strategy for patients with small to mid-sized infrarenal abdominal aortic aneurysms,” is how Michael R. Jaff (Boston, USA) describes the Nectero Endovascular Aortic Stabilization Treatment (Nectero EAST®) System from Nectero Medical in a recent roundtable discussion.

Jaff was joined by an international panel of physician experts—namely Andrew Holden(Auckland, New Zealand), Ramon Varcoe (Sydney, Australia) and Stephen W K Cheng (Hong Kong)—to discuss current AAA management strategies, as well as the potential of the Nectero EAST System to treat AAA from 3.5 to 5.0 cm.

Conversing at the 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK), the panellists explain that the Nectero EAST System offers a new method that could stabilise the growth of aortic aneurysms and potentially minimise the risk of rupture.

Watch now: https://vascularnews.com/nectero-east-system-touted-as-potential-game-changer-for-smaller-infrarenal-abdominal-aortic-aneurysms/




This video is sponsored by Nectero Medical, Inc.

 “A truly novel and potentially groundbreaking treatment strategy for patients with small to mid-sized infrarenal abdominal aortic aneurysms,” is how Michael R. Jaff (Boston, USA) describes the Nectero Endovascular Aortic Stabilization Treatment (Nectero EAST®) System from Nectero Medical in...

24/08/2023

Experts gathered at the Society for Vascular Surgery’s 2023 Vascular Annual Meeting (VAM) in National Harbor, Maryland (June 14–17) to discuss the latest innovation from Shockwave Medical—the Shockwave L6 Peripheral Intravascular Lithotripsy (IVL) catheter (available in 8-12 mm diameter sizes), for use in calcified large-vessel interventions.

Karan Garg, MD (New York City, USA) was joined by Misty Humphries, MD (Sacramento, USA) and Mathew Wooster, MD (Charleston, USA) to explore how the new device has changed their practice and treatment approach in larger vessels.

According to Humphries, the larger Shockwave L6 catheter “opens up the ability to do thoracic endografting and aortic endografting for patients with calcified vessels”.

Wooster added that, while the Shockwave M5+, worked and was a “great” device, the L6 simplifies certain procedures. He explained: “Instead of having to use a small Shockwave balloon that’s truly undersized and then come back with a standard balloon in order to get up to a large enough diameter for our large-bore device, you do it in one step, and it just makes things much more efficient.”
To demonstrate the benefits of the new L6 in clinical practice, Wooster shared with the group a case that showed “how the L6 can really impact our care, and change the pathways that we have available to us”.

The case involved a 70-year-old man with a 5cm juxtarenal aneurysm, subacute ischemia, and a nearly occluded common femoral artery. Sharing the outcomes, Wooster detailed that the L6 device ensured the common femoral artery was “almost pristine” following treatment.

Commenting on the case, which Wooster said he was “fully expecting to fail,” Humphries highlighted the impressive trackability of the L6, with Garg remarking on the “well-executed” nature of the treatment.
The Shockwave L6 catheter is available in the US-only.
This video is sponsored by Shockwave Medical.

https://vascularnews.com/shockwave-l6-catheter-achieves-almost-pristine-result-in-challenging-case/

NOTE: This video is ONLY available to watch in selected countries and geographies

23/08/2023

First patient treated in global strategic collaboration between Cydar Medical and Medtronic

Cydar Medical has announced the successful treatment of the first patient in a strategic collaboration with Medtronic.

02/08/2023

New study reports positive performance of AI-powered assessment of biomarkers for growth prediction of AAAs

The characterization of aortic tissue by means of biomechanics-based biomarkers as part of a compound RAW Map showed “very good performance.”

24/07/2023

Nectero Medical receives FDA clearance of IND application to initiate Phase II/III clinical trial of Nectero EAST system

Nectero Medical today announced that the US FDA has granted investigational new drug (IND) clearance for the company to initiate the stAAAble study.

21/07/2023

What are the major benefits of a lytic-free ? Michael Lichtenberg shares his experiences with , presenting results of the Arnsberg study confirming safety & efficacy of the system and reinforces registry outcomes.

https://lnkd.in/e67QD8AC


This video was filmed by Inari Medical and is being sponsored for distribution in association with Vascular News, Interventional News, Venous News and CX Vascular. Biba Medical bears no responsibility for the assets used in the production of this video.

Why is clot removal crucial for patients suffering from DVT?

19/07/2023

Paris Vascular Insights, a Course to learn, share and improve vascular techniques for patient care!
Led by Koen Deloose, Eric Ducasse, Yann Gouëffic and Stéphan Haulon, the Course will provide a three-day programme with hot topics, challenging cases, joint sessions, interactive learning discussions and hands-on sessions to fine-tune your skills. 👨🏻‍⚕️🩺
Make the most out of 2023 by reviewing its educational content and selecting the sessions that best fit your educational journey and join us to interact with leading experts in the field of vascular surgical and endovascular techniques! ➡️ https://bit.ly/3CFCst9
📆 8, 9 & 10 November, 2023
🇫🇷 Carrousel du Louvre, Paris, France
Sponsored by PVI Course

18/07/2023

“There is an increasing awareness that we need to get aneurysm sacs to regress after endovascular aneurysm repair [EVAR],” Andrew Holden (Auckland, New Zealand) stated during a recent discussion with Michel Reijnen (Arnhem, The Netherlands) on potential solutions in this space from Shape Memory Medical. The pair spoke on the topic at the recent 2023 Charing Cross (CX) International Symposium (25–27 April, London, UK), outlining some updated results from the AAA-SHAPE study and considering the future of abdominal aortic aneurysm (AAA) sac treatment with shape memory polymer.

By way of background, Holden pointed out that stable or growing aneurysms are associated with a “significantly higher” mortality than those that regress. He explained that the AAA-SHAPE study has been designed to assess whether the shape memory polymer active aneurysm sac management technique could be a successful strategy for management of the aneurysm sac during EVAR.

Holden reported that so far, the trial has recruited 35 patients in New Zealand and The Netherlands, 70% of whom have had 12-month follow-up. “We have really refined the technique,” he said, adding that the investigators have seen a “very encouraging” safety profile with no device related adverse events.

Looking ahead, Reijnen stated that there is “still a lot to be done,” underscoring a need for level I evidence in the form of a randomised trial, with Holden closing that, for the time being, “we are another step down the road” toward active aneurysm sac management.

https://vascularnews.com/shape-memory-polymer-another-step-down-the-road-toward-active-aneurysm-sac-management/

This video is sponsored by Shape Memory Medical.

“There is an increasing awareness that we need to get aneurysm sacs to regress after endovascular aneurysm repair [EVAR],” Andrew Holden (Auckland, New Zealand) stated during a recent discussion with Michel Reijnen (Arnhem, The Netherlands) on potential solutions in this space from Shape Memory ...