Vivasure Medical has completed a Series C financing of €16.2m (US$18.3m). The round was led by Life Sciences Partners (The Netherlands), investing from its LSP Health Economics Fund, and co-led by Evonik Venture Capital (Germany), alongside Panakes Partners (Italy) with returning Series A and B investors led by Fountain Healthcare Partners (Ireland).
Twelve-month follow-up of the everolimus-eluting, Absorb bioresorbable vascular scaffold (Abbott Vascular) below the knee has demonstrated “excellent safety, patency, and freedom from target lesion revascularisation,” in the treatment of focal tibial and distal popliteal lesions, according to a paper published in JACC: Cardiovascular Interventions.
The new Excluder iliac branch endoprosthesis (Gore) is safe and effective at treating aortoiliac aneurysms and common iliac artery aneurysms, maintaining blood flow into the internal iliac artery, and preventing the complications associated with internal iliac artery sacrifice, Darren Schneider, New York, USA, told delegates at the Vascular Annual Meeting (9–11 June, National Harbor, USA). Another study, with the Cook Medical Zenith Branch Endovascular Graft – Iliac Bifurcation, showed minimal additional perioperative time, no increase in perioperative morbidity and excellent long-term branch patency with the device.
Toshiba Medical Systems has announced the acquisition of Belfast-based Medical Imaging NI Limited. Medical Imaging NI has been a Toshiba Medical Systems partner for 25 years as a distributor for imaging equipment in Northern Ireland.
The CardioVascular Coalition (CVC)—a group of community-based cardiovascular and endovascular care providers, physicians, and manufacturers created to advance community-based solutions designed to improve awareness, prevention, and intervention of vascular disease—is urging healthcare leaders, policymakers, patient advocates and other stakeholders to join them in recognising September as “Peripheral Artery Disease (PAD) Awareness Month”, a time designated to increasing awareness about the disease and treatment options to save limbs and lives.
Despite “overwhelming data” demonstrating the efficacy of antiplatelet therapy in heart disease and stroke, data for antiplatelet therapy for peripheral arterial disease (PAD) are “less compelling”, according to the investigators of the EUCLID trial, which will investigate whether treatment with ticagrelor versus clopidogrel, given as antiplatelet monotherapy, will reduce the incidence of cardiovascular and limb-specific events in patients with symptomatic PAD.
One-year outcomes of a prospective, non-randomised, feasibility trial evaluating the treatment of aneurysms involving the proximal descending thoracic aorta indicate that total repair can be achieved by using a single branched endograft (TAG Thoracic Branch Endoprosthesis, Gore).
Endovascular aneurysm repair (EVAR) using the Zenith endograft (Cook Medical) represents durable repair with a low risk of abdominal aortic aneurysm-related death at 14 years, according to data presented by Fabio Verzini, professor of Vascular Surgery, University of Perugia, Italy, at the Vascular Annual Meeting (9–11 June, National Harbor, USA). Despite this, the long-term survival rate of 24% shows that long-term outcomes for EVAR “remain poor,” Verzini said.
Bluegrass Vascular Technologies has received CE mark approval and is launching limited commercial sale of its Surfacer Inside-Out access catheter system. The Surfacer system is indicated for obtaining central venous access to facilitate catheter insertion into the central venous system via a novel “Inside-Out” approach.
Gore has announced the commercial availability of the Gore DrySeal Flex introducer sheath, after recently gaining clearance for use by regulatory bodies in the USA, Europe, Canada, and Australia. The device is designed with a distinct combination of enhanced flexibility, kink resistance, and a hydrophilic coating to facilitate access to challenging anatomies and branch vessels, such as the common iliac arteries, during endovascular repair procedures.
Getinge Group announced on 25 August 2016 the launch of a new, highly flexible angiography solution for surgery, interventional and Hybrid operating room (OR) procedures in the United States. Jointly developed with GE Healthcare, a leader in providing transformational medical technologies, this integrated solution pairs the Magnus OR table system from Getinge Group’s Maquet brand with GE’s Discovery IGS 730 angiography system. According to Getinge Group, the combination of these two state-of-the art systems enables hospitals to expand the range of surgical procedures and interventions they offer patients as well as optimise the use of their Hybrid OR.
Admedus announced on 25 August 2016 that the manufacturing team have met the internal timeline of being prepared for the manufacture of VascuCel for the November launch date.
Cardiovascular Systems has released procedural and 30-day results from its LIBERTY 360° study in a late-breaking presentation at the 2016 Amputation Prevention Symposium (AMP; 10–13 August, Chicago, USA), showing high freedom from major adverse events across all Rutherford classes following endovascular interventions, including atherectomy.
Lombard Medical announced on 22 August 2016 “a significant operational restructuring and the exploration of strategic alternatives to enhance shareholder value” with the closure of its operations in the USA. The company added it would be allocating its resources to exclusively support the new Altura AAA stent graft system and the recently CE-marked IntelliFlex LP delivery system for Aorfix in the European Union, Japan and other key international markets.
The US Food and Drug Administration has announced that Dutch company DSM Biomedical BV—Cook Medical’s supplier of hydrophilic coating for the Roadrunner Uniglide hydrophilic wire guide, has recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4–280µm.
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