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 the best treatment option for severe occlusive aortoiliac disease among other key updates in the vascular space.
1. Medtronic announces first enrolment in head-to-head global randomised trail evaluating durability of EVAR
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 Medtronic Endurant II/IIs stent graft system and Gore Excluder AAA device family systems.
2. “A very grey area”: EVOCC trial addresses best treatment option for aortoiliac disease
Athanasios Saratzis (University of Leicester, Leicester, UK) speaks to Vascular News about the EVOCC trial, which he hopes will dispel patient and physician “uncertainty” around the best treatment option for severe occlusive aortoiliac disease. This randomised study recently received funding from the UK’s National Institute for Health and Care Research (NIHR), marking the first step in what Saratzis states will be “one of the largest peripheral arterial disease [PAD] trials in the UK over the next few years”.
3. Age is just a number: Individual patient data meta-analysis probes safety of CEA in the elderly
A newly published meta-analysis of individual patient data has found that older patients with symptomatic carotid disease are likely to benefit as much from timely intervention as younger patients. Speaking to Vascular News in light of this key finding, senior author Dominic Howard (Oxford University Hospitals NHS Trust, Oxford, UK) stresses that “vascular surgeons must not turn down symptomatic patients just because of their age”.
4. ESVS AAA guidelines alert recommends “enhanced surveillance” in patients treated with Nellix device
In a “focused update” to their 2019 recommendations, the European Society for Vascular Surgery (ESVS) abdominal aortic aneurysm (AAA) guidelines writing committee has published advice on the surveillance and management of patients treated with the Nellix endovascular aneurysm sealing (EVAS) system (Endologix).
5. Multidisciplinary teams at the heart of new guidelines on aortic disease management
Closer ties between cardiologists, cardiac surgeons and vascular surgeons will be a hallmark of the future treatment of diseases of the aorta, a leading figure behind new guidelines for the diagnosis and management of aortic disease tells Vascular News.
6. Penumbra launches Lightning Flash mechanical thrombectomy system
Penumbra has announced the US Food and Drug Administration (FDA) clearance and launch of its Lightning Flash mechanical thrombectomy system. “Lightning Flash features Penumbra’s novel Lightning intelligent aspiration technology, now with dual clot detection algorithms,” the company notes in a press release, adding that the system is designed to quickly remove large blood clots in the body, including venous thrombus and pulmonary emboli (PE).
7. Cardiovascular Systems enrols first patient in Japan for KAIZEN clinical study
Cardiovascular Systems Inc (CSI) recently announced initiation of the KAIZEN clinical study of its Diamondback 360 peripheral orbital atherectomy system (OAS) for the treatment of calcified plaque in patients with peripheral arterial disease (PAD). The study is intended to support regulatory approval in Japan.
8. Funding secured to advance development of Pulse IVL system
AVS has announced that it raised US$20 million in Series B financing, which the company says will accelerate clinical trial timelines for its device for peripheral application in pulsatile intravascular lithotripsy (PIVL) cases and advance development and preclinical work on a PIVL device for coronary cases.
9. ReCor appoints Lara Barghout to lead commercialisation of Paradise renal denervation system
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 will lead the ReCor business strategy and organisation in the global commercialisation of ReCor’s Paradise ultrasound renal denervation system for the treatment of hypertension.
10. Hypotension and AV access thrombosis: Causation or just association?
Aisha Shaikh (Memorial Sloan Kettering Cancer Centre, New York, USA) has staked out a claim that, though hypotension was “associated” with arteriovenous access (AV) thrombosis, it should be far from the only consideration in choosing an access modality. She did so while presenting at VEITHsymposium (15–19 November, New York, USA).