Cagent Vascular has announced the issuance of its CE marking for the Serranator percutaneous transluminal angioplasty (PTA) serration balloon catheter. Cagent Vascular has also achieved its ISO 13485 Certification. The Serranator is one of a family of peripheral artery disease (PAD) technologies which incorporates proprietary serration technology to an angioplasty balloon.
Positive single-centre 24-month results from Intact Vascular’s TOBA (Tack optimised balloon angioplasty) clinical study were presented at the 2017 VEITHsymposium 2017 (14–18 November, New York City, USA) by Christian Wissgott (Westküstenklinikum Heide, Heide, Germany).
Vascular Flow Technologies (VFT) has announced the successful conclusion of a strategic intellectual property out-licencing agreement with Biovic Sdn bhd.
Bayer and its cooperation partner Janssen Research & Development have announced two publications of further data from the Phase III COMPASS study in The Lancet, one in patients with peripheral artery disease (PAD) and the other in patients with coronary artery disease (CAD).
InspireMD has announced it has signed Diverse Devices as its exclusive distributor for Australia and New Zealand, and has signed Do Gia Production and Trading JSC as its exclusive distributor in Vietnam. The company’s product line includes the Cguard embolic prevention system (EPS).
CryoLife, Inc, a leading medical device and tissue processing company focused on cardiac and vascular surgery, announced today that it has completed its previously announced acquisition of Jotec AG, a German-based, privately-held developer of technologically differentiated endovascular stent grafts, and cardiac and vascular surgical grafts, focused on aortic repair.
Following a fenestrated endovascular aneurysm repair (FEVAR), the infrarenal aortic neck often continues to dilate. At the 2017 VEITHsymposium, Benjamin Starnes (University of Washington, Seattle, USA) suggested that such dilation is harmful when observed in standard EVAR practised outside instructions for use (IFU) or in association with a hostile neck. However, Starnes said that aortic neck dilation is harmless when observed with FEVAR, and that “less device oversizing may be acceptable given long seal zone lengths”.
The use of surgical simulators is important to assess competence, plan complex cases and develop skills, but they “do not replace clinical and surgical experience,” according to José Fernandes e Fernandes (Lisbon Academic Medical Centre and Lisbon Cardiovascular Institute, Lisbon, Portugal), who spoke at the 2017 VEITHsymposium (14–18 November, New York, USA).
PQ Bypass has received conditional approval of its investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate the pivotal DETOUR II clinical trial. As the first-ever pivotal trial for percutaneous femoropopliteal bypass, DETOUR II will evaluate the safety and effectiveness of the DETOUR System in up to 292 patients with lower limb ischaemia due to long blockages (>15cm) in the superficial femoral artery (SFA) caused by peripheral artery disease (PAD).
Gore has announced the first implant of the Gore Excluder Conformable abdominal aortic aneurysms (AAA) endoprosthesis in the USA. The procedure took place on 19 December, 2017 at Maimonides Medical Center in New York, USA by Robert Rhee, chief of Vascular and Endovascular Surgery, and national principal investigator.
ReCor Medical announced today randomisation of its 146th, and final, subject in the SOLO cohort of its RADIANCE-HTN study. RADIANCE-HTN, ReCor’s study of its Paradise renal denervation system in people with hypertension, involves two study cohorts: “SOLO”, whose subjects are removed from anti-hypertensive medication, and “TRIO” whose subjects are put on standardised medication. Both cohorts are randomised, blinded, sham-controlled, and powered independently for efficacy.
Fenestrated or branched endovascular aneurysm repair (F/BEVAR) for thoracoabdominal or complex aortic aneurysm patients “is not cost-effective at two years” compared with open repair, particularly for patients with para/juxtarenal abdominal aortic aneurysms and infradiaphragmatic thoracoabdominal aortic aneurysms.
Avinger, a developer of treatments for peripheral artery disease (PAD), has announced the first use of their next generation Pantheris lumivascular atherectomy system. The device was used by vascular surgeon Arne Schwindt to treat patients at St Franziskus Hospital in Münster, Germany.
XableCath, a clinical stage medical device company, announced its XableCath blunt tip support catheter has received clearance from the US Food and Drug Administration (FDA). The blunt tip catheter facilitates true lumen passage of lesions, both above and below the knee, in the peripheral vasculature. Procedures using the XableCath blunt tip catheters can be performed quickly and safely, allowing physicians to more effectively treat peripheral arterial disease (PAD).
Cardiovascular Systems (CSI) has announced two new partnerships broadening the company’s product portfolio. According to a company release, CSI is now the exclusive US distributor of OrbusNeich balloon products. Additionally, the company has signed an original equipment manufacturer agreement with Integer Holdings Corporation for CSI-branded ZILIENT guidewires.
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