November 4, 2014—Cook Medical announced that 5-year results from the clinical trial of the Zilver PTX paclitaxel-eluting stent for treating peripheral arterial disease (PAD) confirmed long-term patency for patients treated with the device. The trial’s global principal investigator, Michael Dake, MD, of Stanford University, presented the findings at the VIVA 2014: Vascular InterVentional Advances meeting in Las Vegas, Nevada.
November 5, 2014—Principal investigator Kenneth Rosenfield, MD, reported new patency data from the LEVANT 2 clinical trial showing that proper angioplasty technique can significantly improve outcomes of drug-coated balloon (DCB) treatment. Dr. Rosenfield, who is from Massachusetts General Hospital in Boston, Massachusetts, presented the findings at the VIVA 2014: Vascular Interventional Advances meeting in Las Vegas, Nevada.
November 4, 2014—Intact Vascular announced the completion of the TOBA-BTK (Tack Optimized Balloon Angioplasty—Below the Knee) study. This multicenter pilot study focused on gathering data supporting the safety and performance of Intact Vascular’s Tack Endovascular System in patients with critical limb ischemia (CLI) due to vascular disease below the knee. Thirty-five patients were enrolled in this study, which targeted diseased tibial vessels for treatment.
November 4, 2014—Covidien plc announced 12-month results of the DEFINITIVE AR study, which is designed to identify the clinical benefits of plaque removal using directional atherectomy followed by treatment with a drug-coated balloon (DCB). This randomized study included angiographic follow-up at 1 year to assess patency. Professor Thomas Zeller, MD, presented the data at the VIVA 2014: Vascular Interventional Advances meeting in Las Vegas, Nevada.
November 4, 2014—Vascular Solutions, Inc. announced that it has entered into an agreement with NuCryoVascular LLC under which Vascular Solutions will serve as exclusive distributor of the PolarCath peripheral dilatation system in the United States. Vascular Solutions expects to begin sales of PolarCath to customers through its direct United States sales force during the first quarter of 2015.
November 2, 2014—Spectranetics Corporation and Covidien announced a definitive agreement under which Spectranetics will acquire Covidien s Stellarex drug-coated angioplasty balloon (DCB) platform for $30 million. The companies advised that the transaction is subject to approval by the Federal Trade Commission and other regulatory agencies, as well as closure of the pending acquisition of Covidien by Medtronic. The Medtronic–Covidien transaction is expected to occur in early 2015.
October 30, 2014—Biotronik announced the initiation of the BIOLUX P-III All-Comers Registry with the first patient implantation in the study, which will collect and assess safety and efficacy data on the company’s Passeo-18 Lux drug-releasing balloon (DRB) for the treatment of obstructive disease of the infrainguinal arteries. The prospective multicenter “all-comers” study is designed to provide evidence on the role of the Passeo-18 Lux in treating peripheral artery disease in all its complexity. The study will enroll real-world patients, allowing inclusion of a diverse patient population with lesion characteristics not typically enrolled in clinical studies.
October 23, 2014—ReFlow Medical, Inc. announced US Food and Drug Administration (FDA) marketing clearance of the company’s Wingman35 crossing catheter. The Wingman35 crossing catheter is indicated to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature and enable rapid, routine, off-the-shelf lesion crossing.
During the Second World War, Michael Debakey demonstrated that lives and limbs could be saved using surgical treatment of vascular injuries.1 With the development of endovascular techniques, it became evident that some selected cases of vascular trauma could be treated using an endovascular approach. Injuries to the vascular vessels can be penetrating or blunt and can be the result of violence, accidents, or be iatrogenic in origin.
At the Vascular Interventional Advances (VIVA) 2014 meeting, Covidien announced nine-month results of the DURABILITY Iliac study and the addition of the iliac indication for its EverFlex stent. The nine-month results confirm the safety and effectiveness of the EverFlex and Protégé GPS self-expanding stent systems for the treatment of lesions of the common and external iliac arteries
Medtronic s IN.PACT Admiral drug-coated balloon, used for the treatment of peripheral artery disease in leg arteries above the knee, provided a consistently favourable treatment effect in patients with diabetes in a landmark study of the investigational medical device, which is under review by the US Food and Drug Administration (FDA) for approval
TriVascular announced on 15 October 2014 that the FDA has approved the CustomSeal technology for the Ovation Prime System. With the Ovation Prime endograft system, physicians create a customised seal by filling the conformable O-rings with the CustomSeal polymer, effectively completing the last step of the manufacturing process in vivo.
RPS Gambhir (King’s College Hospital, London, UK) told delegates at the European Society for Vascular Surgery (ESVS) annual meeting (23–26 September, Stockholm, Sweden) that they, as clinicians, had a responsibility to report adverse events after a vascular procedure. He also stated that the ESVS “should take the lead” in facilitating user initiated reporting of adverse events.
The FDA has approved the Lutonix 035 drug-eluting balloon (Bard) for percutaneous transluminal angioplasty, after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4–6mm.
ReFlow Medical has announced the initial clinical use of their Wingman35 crossing catheter and speX shapeable support catheter by Andrej Schmidt, Park Hospital Leipzig, Germany. The devices were recently granted CE mark approval for use in the peripheral vasculature.
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