MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of patients with below-the-knee (BTK) disease. Selution SLR is the first DEB to be awarded Breakthrough Device designation by the US Food and Drug Administration (FDA). The objective of the prospective PRISTINE trial is to evaluate the safety and efficacy of the Selution SLR sirolimus DEB in the treatment of infra-inguinal occlusive lesions (TASC C and D) in patients with chronic limb-threatening ischaemia in 75 patients over 12 ..read more

Percutaneous Deep Vein Arterialisation (pDVA) with the LimFlow System offers a cost-effective and high-value alternative to traditional therapies or amputation, according to a recent study published in the Journal of Critical Limb Ischemia. Peter Schneider, professor of surgery at the University of California (San Francisco, USA) and co-author of the published article, said: “The cost-effectiveness analysis builds on recently published 12-month data from the PROMISE I study by showing that pDVA with the LimFlow System can be a high-value therapy alternative to the status quo for no ..read more

 Anna Prent (London, UK) chats to Vascular News at London Aortic Symposium (11–12 October 2018, London, UK), about the need to treat type I endoleaks due to the “high risk of secondary sac perfusion and rupture”. Patients should receive “tailor-made treatment” says Prent, who notes that there is no “one size fits all” or “perfect endovascular solution”. Centres should focus on what they specialise in but different treatment options also need to continuously be developed, she adds. “Most importantly,” Prent concludes: “we need to make sure that the device outlives the patient”. The post Treatm ..read more

Speaking on current trends in amputation rates with critical limb-threatening ischaemia (CLTI) patients, Misty Humphries (Sacramento, USA) tells Vascular News that while Medicare data shows that amputation rates are decreasing across the USA overall, there are “certain geographical areas” that have high rates, with many of these “located in the south” or in regions that “may not have vascular specialists”. “The disparities that we see in my research I believe are truly access-based,” says Humphries, further drilling down to emphasise health insurance, time a ..read more

Koya Medical announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for its active compression therapy system Dayspring for the treatment of lymphoedema and venous diseases that impact lymphatic flow in the lower extremities. The company also announced the appointments of three veteran executives to its leadership team to support commercialisation. Patients treated with Dayspring receive standard of care active compression therapy with a mobility-enabling wearable device. The system includes a low-profile active garment made of soft, breathable mesh using ..read more

Koya Medical announced today that it has received US Food and Drug Administration (FDA) 510(k) clearance for its active compression therapy system Dayspring for the treatment of lymphoedema and venous diseases that impact lymphatic flow in the lower extremities. The company also announced the appointments of three veteran executives to its leadership team to support commercialisation. Patients treated with Dayspring receive standard of care active compression therapy with a mobility-enabling wearable device. The system includes a low-profile active garment made of soft, breathable mesh using ..read more

The European Union (EU) Medical Devices Regulation (MDR) takes effect from today (26 May 2021). The Regulation revises quality and safety standards and the range of regulated devices and was first initiated in May 2017, with an initial three-year transition period applied. Implementation was delayed by 12 months due to the COVID-19 pandemic. According to the European Commission there are over 500,000 types of medical devices and in vitro diagnostic medical devices (IVDs) on the EU market. These have a “fundamental role in saving lives by providing innovative healthcare solutions for the diagno ..read more

LimFlow stent LimFlow SA recently announced the publication of 12-month data from the full patient cohort in its PROMISE I study of the LimFlow percutaneous deep vein arterialisation (pDVA) system in the Journal of Vascular Surgery. Results showed sustained positive outcomes for both amputation-free survival and wound healing. The minimally-invasive LimFlow system is designed to bypass blocked arteries in the leg and deliver oxygenated blood back into the foot via the veins in chronic limb-threatening ischaemia (CLTI) patients who are facing major amputation and have exhausted all other therap ..read more

Peter Schneider “I am going to give you reasons to be excited about your critical limb practice,” Peter Schneider (University of California San Francisco, San Francisco, USA) told delegates attending the International Symposium on Endovascular Therapy (ISET; 9–11 May, Miami, USA), in a talk focusing on innovative tools on the horizon for the treatment of chronic limb-threatening ischaemia (CLTI). “I think critical limb ischaemia has come to the forefront of our practices and of community awareness, and finally now the tools are starting to show that,” he opined. Covering developments in assess ..read more

MolecuLight has partnered with Tissue Analytics, a Net Health company that provides software for the woundcare industry. The purpose of the partnership is to integrate the MolecuLight platform with Net Health’s Tissue Analytics application programming interface (API) programme. For clinical sites using both MolecuLight and Tissue Analytics, wound care clinicians can now upload standard and fluorescence images captured with the MolecuLight i:X device to the patient’s record in the electronic health record (EHR) platform. The integrated platforms allow clinicians to optimise their workflow ..read more