Shockwave Medical has announced plans for DISRUPT PAD III—what it claims is the “largest ever” multicentre randomised study to exclusively enrol patients with calcified peripheral artery disease.
The US Food and Drug Administration (FDA) has granted staged approval for Intact Vascular’s investigational device exemption (IDE) application to begin its TOBA II BTK (Tack optimised balloon angioplasty II below the knee) clinical study. The study will examine the safety and efficacy of the Tack endovascular system when used to repair dissections in the arteries below the knee following percutaneous transluminal angioplasty as a treatment for critical limb ischaemia.
St Jude Medical has announced that, based on the preliminary voting results from St Jude Medical’s Annual Meeting of Shareholders held on 26 October, St Jude Medical shareholders approved the merger agreement under which Abbott will acquire St Jude Medical.
Medtronic has received US FDA 510(k) clearance for the HawkOne directional atherectomy system in a new size for treating patients with peripheral artery disease. The HawkOne system is designed to remove plaque from the vessel wall and restore blood flow. The new HawkOne 6F provides an effective and easy-to-use treatment option for patients with peripheral artery disease both above and below the knee with a single device at a lower profile.
Most people have heard about personalised medicine. How about personalised medical devices? Northwestern’s McCormick School of Engineering researchers Guillermo Ameer and Cheng Sun have teamed up to use 3D printing to develop flexible, biodegradable stents that are customisable to suit a specific patient’s anatomy.
Abbott and St Jude Medical have announced an agreement in principle to sell certain products to Terumo Corporation.The agreement is an important step toward completion of Abbott’s acquisition of St Jude Medical. Abbott’s acquisition of St Jude Medical is expected to close by year-end.
Shockwave Medical has announced positive clinical results from the pooled DISRUPT PAD study, a single-arm, two-phase, multicentre study evaluating the safety and performance of the company’s Lithoplasty system in calcified peripheral lesions. The data were presented at Vascular Intervention Advances (VIVA) 2016 meeting (18–22 September, Las Vegas, USA). “The ongoing positive results from DISRUPT PAD demonstrate that Lithoplasty technology is a promising treatment for patients with calcified peripheral artery disease, a difficult-to-treat population”
Ten-year outcomes from the randomised controlled EMMY trial were presented at CIRSE 2016 (10–14 September, Barcelona, Spain) by Jim Reekers, Academic Medical Center, Amsterdam, The Netherlands. The results have also been published in July 2016 in the American Journal of Obstetrics and Gynecology by de Bruijn AM and colleagues.
Teleflex has announced that it has received US FDA 510(k) clearance to market its Arrow JACC with Chlorag+ard technology and TightTrack tunneler.
Bio2 Medical has announced that the Angel catheter, a new device for the prevention of pulmonary embolism, was placed in two patients at St Mary’s Medical Center in West Palm Beach, USA, by Lawrence Lottenberg and Robert Borrego on 29 September. This is the first commercial usage of the device.
Profusa has announced that receiving the CE mark to market its Lumee Oxygen Platform for continuous, real-time monitoring of tissue oxygen.
Ra Medical has announced receiving CE mark approval for the Dabra atherectomy system with catheter.
Medtronic has announced that the US FDA has cleared the TrailBlazer angled support catheter for use in the peripheral vascular system. Support catheters such as the Trailblazer are often used in endovascular procedures treating complex peripheral artery disease. FDA clearance was received on September 23, 2016.
Shockwave Medical has announced plans for DISRUPT PAD III—what is claims is the “largest ever” multicentre randomised study to exclusively enrol patients with calcified peripheral artery disease. Previous DISRUPT PAD studies utilised Lithoplasty as primary therapy, demonstrating safe, effective and consistent revascularisation of calcified lesions while maintaining future treatment options. To date, the potential benefit of combination therapy in these patients has not yet been evaluated. DISRUPT PAD III will study use of the Shockwave Medical Lithoplasty system in combination with drug-coated balloon therapy to assess short- and long-term outcomes compared to those achievable using traditional balloon angioplasty prior to drug-coated balloon in a calcified patient population.
Spectranetics has announced that the final 12-month results of the Stellarex drug-coated balloon ILLUMENATE pivotal trial have been presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference (29 October–2 November, Washington, DC, USA). The ILLUMENATE trial’s co-principal investigators are Sean Lyden of the Cleveland Clinic, Cleveland, USA, who presented the data, and Prakash Krishnan, Mount Sinai, New York, USA.
Cookies Sociales
Son esos botones que permiten compartir el contenido del sitio web en sus redes sociales (Facebook, Twitter y Linkedin, previo tu consentimiento y login) a través de sistemas totalmente gestionados por dichas redes sociales, así como los recursos (pej. videos) y material que se encuentra en nuestra web, y que de igual manera se presta y gestiona completamente por un tercero.
Si no acepta estas cookies, no podrá compartir nuestro contenido a través de los botones, y en su caso, no podrás visualizar el contenido de terceros que hayamos incrustado en el sitio.
No las utilizamos