Six presentations on Silk Road Medical’s Enroute transcarotid neuroprotection and stent system were given at the Society for Vascular Surgery annual meeting (8–11 June, National Harbor, USA).
Gore has announced that its TAG thoracic device family has exceeded 100,000 devices distributed worldwide.
Enrolment into Gore’s early feasibility study evaluating the Excluder thoracoabdominal branch endoprosthesis (TAMBE) for the treatment of aortic aneurysms involving the visceral branch vessels has now been completed. The TAMBE is designed to be the first complete off-the-shelf solution for the treatment of this complex disease.
Intact Vascular has announced that its Tack Optimised Balloon Angioplasty III (TOBA III) clinical trial has commenced enrolment, with the first patient treated by Klaus Brechtel at the Franziskus-Hospital in Berlin, Germany.
The Netherlands presidency of the European Council and representatives of the European Parliament have reached a political agreement on two draft regulations for medical devices. The new regulations are aimed at ensuring that medical devices and in vitro diagnostic medical devices are safe while allowing patients to benefit from innovative health care solutions in a timely manner. However, the agreement is subject to the approval by the Council’s Permanent Representatives Committee and of the Parliament’s ENVI committee.
Cardionovum has announced the completion of enrolment of the RAPID trial, which is investigating the safety and effectiveness of the company’s Legflow drug-coated balloon.
OrbusNeich has expanded its portfolio to include products to treat peripheral artery disease. The JADE and Scoreflex PTA balloons are the company’s first entry devices for lower limb and arteriovenous fistula intervention.
iVascular’s Luminor 18 drug-eluting balloon, has received CE mark approval.
Boston Scientific has announced that its GreenLight XPS laser therapy system, used for the treatment of prostatic enlargement, known as benign prostatic hyperplasia, received positive guidance from the National Institute for Health and Care Excellence (NICE).
Gore has received CE mark for its Excluder conformable abdominal aortic aneurysm (AAA) device, a product designed for the treatment of abdominal aortic aneurysms in patients with challenging anatomies.
Bayer has announced that a phase III trial evaluating its oncology compound Stivarga (regorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma has met its primary endpoint of a statistically significant improvement in overall survival.
Scott Trerotola, Stanley Baum professor of Radiology and chief, Vascular and Interventional Radiology, University of Pennsylvania Medical Center, Philadelphia, USA, discussed how competition improves interventional radiology, while delivering the Dr Charles T Dotter Lecture at the 2016 Society of Interventional Radiology (SIR) annual meeting in Vancouver, Canada.
Many physicians now believe that immunotherapy is a disruptive field in cancer medicine. Interventional oncology can either “snooze and lose” as one prominent interventional radiologist put it on a recent podium presentation, or wake up and do the research needed on how best to harness the potential of this field when using interventional oncology treatments.
The Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC) protocol 06 SIRveNIB randomised controlled study of SIR-Spheres Y-90 resin microspheres versus sorafenib in the treatment of unresectable primary liver cancer (hepatocellular carcinoma or HCC) has completed its target enrolment of at least 360 patients.
The US Food and Drug Administration (FDA) has finalised its efforts to streamline the “compassionate use” process, used by physicians to access investigational drugs and biologics for patients with limited treatment options.
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