Clinical News

VentureMed Group announces “impressive” 12-month Flex vessel prep data

VentureMed Group, a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced data presented at the VEITHsymposium (15–19 November, New York, USA). Overall, the data presented demonstrated that Flex vessel prep used prior to balloon angioplasty improves 12-month outcomes both in PAD and AV fistulas and grafts.

“AV Access management is a critical component of successfully treating AV patients over time,” said John Aruny (Dialysis Access Institute, Orangeburg, USA), primary investigator of the Flex Vessel Prep AV registry clinical study, the 12-month outcomes of which he presented at VEITHsymposium. “The FLEX AV Registry 12-month outcomes shows that utilising Flex vessel prep provides more time between interventions and continues to excel in the very difficult cephalic arch lesions.”

The study was a single-arm, prospective study conducted in eight centres in the USA with 114 real-world patients.

The Flex AV Registry 12-month outcomes demonstrate sustained patency across most patients and particularly good results specifically in the cephalic arch.

„ 49% patency for all AV fistula patients (comparable historical data 26%)

„ 59.7% patency for cephalic arch lesions (comparable historical data 0–33.9%)

„ AV grafts had average time to target lesion revascularisation of 228 days (41.2% patency at nine months)

„ No observed serious adverse events.

“Vessel preparation has become a necessary step for better patient outcomes,” said Eric Secemsky, director of vascular intervention, Beth Israel Deaconess Medical Center (Boston, USA), who presented the 12-month results of the Belong study with Flex vessel prep system prior to drug-coated balloon (DCB). “Vessel preparation in PAD with Flex creating longitudinal microincisions prior to DCB therapy had impressive freedom from clinically driven target lesion revascularisation and looks to improve outcomes by lowering balloon inflation pressures and potentially enhancing drug delivery.”

The Belong study was a singlecentre, single-arm, prospective study conducted with 41 patients in Fribourg, Switzerland.

12-month efficacy results

„ 97.5% (39/40) freedom from clinically driven target lesion revascularisation

„ 84.2% (32/38) freedom from target lesion restenosis via duplex

„ 14/32 patients had stents

„ 100% freedom from major amputation.

Viz.ai announces positive new data from large aortic dissection AI real-world study

Viz.ai recently announced new data from a large aortic dissection artificial intelligence (AI) real-world study that supports the use of its AI technology for the detection of suspected aortic dissection. Data from the new study, which were presented at VEITHsymposium 2022 (15–19 November, New York, USA), validate the company’s industry-leading dissection detection algorithm, part of the Viz Aortic solution.

An abstract by Viz.ai, in collaboration with Avicenna.ai, entitled “Real-world validation of a deep learning AI-based detection algorithm for suspected aortic dissection,” reported the performance of the Viz Aortic Dissection Algorithm on 1,303 computed tomography angiography scans collected from over 200 US cities. The algorithm demonstrated a sensitivity of 94.2%, specificity of 97.3%, as well as a positive predictive value of 80.1% and negative predictive value of 99.3%. The authors concluded: “These findings provide significant real-world validation of a deeplearning AI-based detection algorithm for suspected aortic dissection. Automated detection may have a positive downstream effect on patient triage leading to accelerated care coordination, earlier diagnosis, timely initiation of life-saving interventions, and better patient outcomes.”

“My experience as a clinician and AI developer has shown me that care teams need solutions that are not only accurate but that will enable them to be more efficient,” said Peter Chang (UC Irvine, Irvine, USA). “The application of this aortic algorithm into the workflow has the potential to move the needle for care teams treating this deadly disease.”

According to a company press release, Viz Aortic accelerates time-tonotification to specialists giving them access to clinically-relevant imaging and patient information for appropriate patient treatment plans. The solution includes AI-powered alerts, highfidelity mobile image viewing, relevant clinical information, and HIPAAcompliant communication to facilitate workflow and improve patient care for all aortic conditions.

“Acute aortic dissection is a deadly disease, and mortality for an untreated dissection is about 50% by 24 hours. In 2011, the IRAD [International

Registry of Acute Aortic Dissections] investigators showed us that there is often a delayed recognition and treatment of acute aortic dissection, leaving many patients at risk for another cardiovascular event,” said Jayme Strauss, chief clinical officer at Viz.ai. “These new data show that Viz Aortic has the power to help care teams coordinate and improve care for these patients in a real-world setting with a diverse patient population.”

Contego completes enrolment of PERFORMANCE II carotid stent trial

Contego Medical has announced that enrolment of the PERFORMANCE II clinical trial has been completed.

PERFORMANCE II is intended to evaluate the safety and effectiveness of the Neuroguard integrated embolic protection (IEP) three-in-one carotid stent and post-dilation balloon system with IEP. The Neuroguard IEP system is designed to treat clinically significant carotid artery stenosis while improving procedural safety through the integration of the stent, balloon and an embolic filter, all in a single device.

“The Neuroguard IEP system combines a truly innovative stent design with a multi-function delivery platform for advanced protection from stroke, while reducing the number of catheter exchanges needed to complete the procedure,” said Christopher Metzger (Holston Valley Medical Center, Kingsport, USA), lead enroller in the trial. “Additionally, it has outstanding conformability for a closed-cell stent, allowing the advantages of this stent system in a wide variety of carotid anatomies.”

PERFORMANCE II is a prospective, multicentre, single-arm, open-label study for the treatment of carotid artery stenosis in subjects at high risk for carotid endarterectomy (CEA). The trial enrolled 305 patients at 32 sites in the USA and Europe. The principal investigators of the study are William Gray (Main Line Health, Wynnewood, USA) and Ralf Langhoff (Sankt Gertrauden Hospital, Berlin, Germany). Results of the study will be used to support a US Food and Drug Administration (FDA) premarket approval application.

“The Neuroguard IEP technology may offer significant benefits to patients suffering from severe carotid stenosis, specifically with the potential to lower the embolic burden and overall stroke rates,” said Gray.

Neuroguard IEP system is both safe and effective,” added Stacy Enxing Seng, chairman of the board of Contego. “We believe that, once available, the Neuroguard IEP system has the potential to be the standard of care for the treatment of extracranial carotid disease.”

The Neuroguard IEP system is designed to safeguard against stroke by integrating a novel, next-generation stent, a pre-positioned post-dilation balloon, and a micro-embolic filter.

The stent has a closed-cell design with FlexRing technology for optimal balance of plaque coverage, radial strength, and flexibility, according to a Contego press release. The integrated 40μm filter is designed to capture more micro-embolic debris than traditional filters.

SPYRAL HTN-ON MED study demonstrates meaningful clinical benefits consistent with other SPYRAL HTN renal denervation trials

Medtronic has announced the sixmonth results from the full cohort of the SPYRAL HTN-ON MED clinical trial. The late-breaking data were presented at the American Heart Association (AHA) Scientific Sessions 2022 (5–7 November, Chicago, USA). With this news, Medtronic has submitted the final module of the Symplicity Spyral premarket approval (PMA) package to the US Food and Drug Administration (FDA) for review and approval.

Patients who were prescribed antihypertensive medications and were treated with the Medtronic Symplicity Spyral renal denervation (RDN) system had a statistically significant and clinically meaningful reduction in office-based systolic blood pressure (OSBP), a key secondary endpoint, compared to patients in the sham control group. However, in the primary endpoint, RDN did not demonstrate a statistically significant reduction in 24-hour ambulatory systolic blood pressure (ABPM) due to increased medications in the sham control group and the potential impacts of the COVID-19 pandemic on the clinical trial environment. The study also included win ratio, a pre-specified secondary endpoint that combines reduction in blood pressure with reduction in medication burden, which enables assessment of the overall beneficial effect of RDN. The win ratio demonstrated significance in favour of RDN versus a sham procedure. Finally, the study met its primary safety endpoint, with a low incidence of procedure-related and clinical adverse events.

“The ON MED study demonstrated significant reductions in office-based blood pressure, the most commonly used measure in clinical practice. Additionally, we saw reductions in absolute blood pressure that were consistent with earlier RDN studies,” said David Kandzari (Piedmont Heart Institute and Cardiovascular Services, Atlanta, USA), SPYRAL HTN-ON MED principal investigator.