Due to its two-dimensional (2D) nature and the high radiation exposure associated with its use, fluoroscopy is an imperfect solution to endovascular surgery’s need for intraoperative imaging. At the 2016 VEITHsymposium (15–19 November, New York, USA), Matthew Eagleton, Cleveland Clinic, Cleveland, USA, presented his centre’s initial experiences with the Intraoperative Positioning System (IOPS; Centerline Biomedical), suggesting that it may represent an opportunity to transition away from fluoroscopy.
The Society for Vascular Surgery (SVS) and the Society for Vascular Nursing (SVN) have issued a statement encouraging vascular surgery teams to actively assist smokers with smoking cessation before surgery.
Current Intact Vascular investors—New Enterprise Associates, Quaker Partners and HIG BioHealth Partners—have exercised their right to invest additional capital as part of the company’s Series B financing, bringing the total raised to US$46m after the financing initially closed in May 2015. The funds will be used to advance the company’s clinical development programme, encompassing both above-the-knee and below-the-knee clinical trials, as well as product development initiatives aimed at expanding the utility of the Tack endovascular system for the treatment of peripheral artery disease.
Abbott has now completed the acquisition of St Jude Medical. The Abbott press release announcing the completion of the acquisition said, “The transaction provides Abbott with expanded opportunities for future growth and is an important part of the company’s ongoing effort to develop a strong, diverse portfolio of devices, diagnostics, nutritionals and branded generic pharmaceuticals.”
The use of hypnosis during endovascular aneurysm repair (EVAR) may improve haemodynamic and respiratory stability and allow faster patient recovery, according to a presentation given at the 2016 VEITHsymposium (15–19 November, New York, USA).
The EVAR 1 trial—investigating the efficacy of endovascular aneurysm repair (EVAR) versus open repair—and the ENGAGE registry—examining the performance of the Endurant (Medtronic) stent graft—are two or the largest EVAR trials conducted to date. In a comparison of their data at the 2016 VEITHsymposium (15–19 November, New York, USA), Dittmar Böckler (University of Heidelberg, Heidelberg, Germany) told delegates that newer generation devices should use EVAR 1 data to benchmark future clinical performance, while the ENGAGE registry demonstrates how technical evolution has already contributed to improved patient outcomes.
Endologix has issued a letter to physicians with updated information about the AFX endovascular abdominal aortic aneurysm system.
Humacyte has announced the initiation of a US phase II arterial bypass clinical trial of Humacyl, an investigational human acellular vessel, to test its safety and efficacy as a lower extremity arterial bypass vessel in patients with peripheral artery disease.
Avinger has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Lightbox L250 imaging console. Avinger says that with this new FDA clearance, the Lightbox L250 now provides detailed measurement of vessels using a touch screen, helping improve visualisation inside the vessel before, during, and after Pantheris Lumivascular atherectomy procedures for the treatment of peripheral artery disease.
The Society for Vascular Surgery (SVS) and the Society for Vascular Nursing (SVN) have signed an affiliation agreement in which the nursing association will be managed from the Chicago, USA-based SVS office.
SoundBite Medical Solutions has performed its first-in-human procedure using shockwave energy to successfully and safely cross a chronic total occlusion (CTO). The 72-year-old male patient had bilateral superficial femoral artery occlusions (both over 20cm in length) in the legs, leading to incapacitating claudication and unfavourable quality of life. Andrew Benko, performed the minimally invasive procedure using a .018” guidewire (ShockWire) that delivered high energy shockwaves into the patient’s arteries to completely cross both occlusions including several calcified nodules and re-establish blood flow.
Lombard Medical and MicroPort Scientific Corporation have announced a strategic partnership and a significant infusion of capital into Lombard Medical by MicroPort. According to a company press release, this partnership will allow Lombard Medical to accelerate commercialisation in key global markets with its two key products: Aorfix, “the only stent graft to hold global approvals to treat abdominal aortic aneurysms with aortic neck angles up to 90 degrees”, and Altura, a “highly innovative stent graft that offers a simple and predictable treatment option for standard abdominal aortic aneurysm anatomy”.
The US Food and Drug Administration (FDA) has granted QT Vascular full Investigational Device Exemption (IDE) approval to begin enrolling patients in the pivotal study of its Chocolate Touch drug-coated balloon. This follows the FDA’s granting of conditional IDE approval in September 2016.
Silk Road Medical data presented at the VEITH Symposium have found comparable results for transcarotid artery revascularisation (TCAR) and carotid endarterectomy (CEA), among other positive conclusions.
Essential Medical has announced the start of the Manta vascular closure device US pivotal trial.
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