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.
The first two patients with abdominal aortic aneurysms (AAA) have been treated with Endologix’s Ovation Alto abdominal stent graft system. The patients were treated by Andrew Holden and Andrew Hill of Auckland City Hospital, Auckland, New Zealand.
The one-year results from Intact Vascular’s Tack Optimized Balloon Angioplasty (TOBA) clinical study have been published in the Journal of Vascular Surgery.
New US research indicates that there was a widespread and steady decline in elective open abdominal aortic aneurysm repairs for Medicare patients from 2003 to 2013, coinciding with a “dramatic” substitution of endovascular aneurysm repair (EVAR) across all geographic areas and a strikingly fast adoption of branched/fenestrated EVAR.
A post-market evaluation of the VenaSeal closure system (Medtronic) has found that, at one month, 100% of treated veins remained closed, quality of life scores improved significantly, and return to work and normal activity times were short. The data showed that treatment of multiple segments in one setting, large veins and superficial veins was safe, with further three-month follow-up now being analysed.
Marianne Brodmann of Medical University Graz, Austria, has presented the final 12-month results of the Stellarex (Spectranetics) ILLUMENATE drug-coated balloon European randomised clinical trial (EU RCT) at the Amputation Prevention Symposium (AMP; 10–13 August, Chicago, USA). The EU RCT Trial enrolled 328 patients, 295 of whom were randomised to treatment with the Stellarex drug-coated balloon (DCB) or a percutaneous transluminal angioplasty (PTA).
Corindus Vascular Robotics has announced that J Aaron Grantham, an interventional cardiologist specialising in the treatment of chronic total occlusions, has joined the company as chief medical officer.
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