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These industry news items below do not reflect the opinion of CIRSE, nor do they engage its responsibility.
Medical company, Bluegrass Vascular, has announced the enrollment of its first patients in the SAVE-US pivotal trial, which evaluates the safety and efficacy of the Surfacer® Inside-Out® Access Catheter System to facilitate reliable upper body central venous access suitable for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.
Guerbet has announced that it will acquire Israeli company Accurate Medical Therapeutics, which has developed a range of microcatheters for embolisation procedures of tumours and vascular aneurysms. These products are currently being registered with the US and European health authorities.
Designed in collaboration with interventional radiologists worldwide, Vectorio® is a unique set of Lipiodol® resistant medical devices including syringes, patented stopcock and sampling devices. Vectorio® is dedicated for mixing and delivering Lipiodol® Ultra Fluid & anticancer drugs during cTACE procedure in adults with known, intermediate-stage hepatocellular carcinoma (HCC).
The Surfacer System from Bluegrass Vascular Technologies is designed to reliably, efficiently and repeatedly gain central venous access through a femoral vein approach and navigation through the venous system to an exit point in the right internal jugular vein, the optimal location for placing a central venous catheter. This proprietary Inside-Out approach allows for the placement and maturation of permanent arteriovenous access options that are associated with improved patient outcomes and reduced cost of care for both hospitals and hemodialysis providers.
Today announced the first implant of the TREO Abdominal Stent Graft System in the TREO Registry: a Post-Market Surveillance Clinical Investigation that aims to assess long term real-world data of the TREO Technology in a Global, Prospective, Multicenter and Observational Study. The technology that will be assessed in the registry is the TREO Abdominal Stent-Graft System which is a device engineered to optimize the endovascular treatment of patients with abdominal aortic aneurysms (AAA). The TREO system has a tri-modular design with a wide range of sizes, and it allows for precise and controlled deployment with the ability to reposition the stent-graft during the procedure.
Siemens Healthineers fully integrates wireless ultrasound into Artis angiography system
Ultrasound guidance reduces puncture related complications. But draping of the transducer and cable is cumbersome and time consuming. Siemens Healthineers’ Artis Freestyle Access with wireless transducers facilitates the use of ultrasound in the angio room by minimizing time for draping. Automatic patient registration, in-room visualization on the Artis large display and single user operation optimize staff utilization even further.
SIRFLOX and FOXFIRE Global findings suggest that adding liver-directed Selective Internal Radiation Therapy (SIRT) to standard first-line chemotherapy may improve overall survival in metastatic colorectal cancer (mCRC) patients with right-sided primary tumours, compared to those receiving chemotherapy alone.
Siemens Healthineers Announces Liver Embolization Planning Software with Automatic Tumor Feeder Detection
Siemens Healthineers’ syngo Embolization Guidance now offers automatic detection of tumor feeders, based on a user’s one-click indication of the liver lesion. The solution aims at making liver tumor treatment safer and more effective by helping interventionalists achieve complete tumor embolization while preserving healthy liver tissue. Software upgrades are available for Artis angiography systems with PURE.
Results of the 360-patient SIRveNIB study showed that the primary endpoint of Overall Survival was not met, but patients experienced an almost two-fold decrease in severe adverse events compared to those treated with sorafenib. Patients treated with Y-90 resin microspheres also experienced benefits in secondary endpoints, including overall Progression-Free Survival, Hazard Ratio, PFS in the liver, overall Time to Progression and TTP in the liver. These findings mirror the findings of the 459-patient SARAH study.
459-patient SARAH Study shows that local treatments of advanced or inoperable Hepatocellular Cancer (HCC) with SIR-Spheres Y-90 resin microspheres did not lead to a planned superiority difference in overall survival compared to daily standard-of-care systemic therapy with sorafenib, yet had significantly reduced side effects and better Quality of Life.
BD (Becton, Dickinson and Company) and CR Bard, Inc. announced a definitive agreement under which BD will acquire Bard for $317 per Bard common share in cash and stock, for a total consideration of $24 billion. The agreement has been unanimously approved by the Boards of Directors of both companies. The transaction is subject to regulatory and Bard shareholder approvals and customary closing conditions, and is expected to close in the fall of 2017.
The Freeway Stent Study was a multicenter, open, prospective randomized study investigated the prevention of restenosis in the treatment of Superficial Femoral Artery (SFA) or Popliteal artery (PI-segment) lesions in the legs. The study examined whether implantation of a Nitinol stent followed by post-dilatation with a drug-eluting balloon (DEB) FREEWAYTM is advantageous to Nitinol stenting and post-dilatation by a plain old balloon angioplasty (POBA) and was conducted in 13 sites in Germany and Austria over 12 months.
Terumo Europe have announced the first commercial clinical case using QuiremSpheres® - the next generation of radioembolisation microspheres for advanced unresectable liver cancer. QuiremSpheres® have been used for the first time outside of a research setting, in clinical practice at the University Clinic Carl Gustav Carus in Dresden, Germany. A multidisciplinary team, consisting of Prof. Dr. med R.T.Hoffmann and Prof. Dr. med. J. Kotzerke and their dedicated teams performed the radioembolization procedure on a patient with metastatic colorectal cancer in the liver. For any questions, please contact Alexandra Vassiliades, Group Manager, Marketing Communications, Terumo Interventional Systems, EMEA : Alexandra.firstname.lastname@example.org
Bluegrass Vascular Technologies announced today their agreement with Merit Medical to distribute their Surfacer System in Europe. The Surfacer System is designed to reduce catheter-associated complications in hemodialysis patients and secure long-term AV access, the desired method for receiving dialysis treatment. The Surfacer Inside-Out Access Catheter System provides reliable, efficient and repeatable central venous access to the right internal jugular (RIJ) vein, the optimal location for placing a central venous catheter. By securing safe and repeatable central venous access to the RIJ, the Surfacer System allows physicians to "avoid going left", thereby protecting AVF placement for better patient outcomes and improved health economics for both hospitals and hemodialysis providers
Bluegrass Vascular Technologies (Bluegrass Vascular), a private medical technology company focused on innovating lifesaving devices and methods for vascular access procedures, announced that it has received CE Mark approval and is launching limited commercial sale of its Surfacer® Inside-Out® Access Catheter System. The Surfacer System is indicated for obtaining central venous access to facilitate catheter insertion into the central venous system via a novel Inside-Out approach.
New data presented by Prof. Dr. Volker Heinemann in an oral abstract session at the European Society of Medical Oncology’s 18th World Congress on Gastrointestinal Cancer suggest that patients with liver-dominant mCRC treated first-line with the combination of mFOLFOX6 and SIR-Spheres Y-90 resin microspheres in the recently published SIRFLOX study experienced a much more profound response to treatment in the liver than those who received chemotherapy alone.1
Results of Asia-Pacific Hepatocellular Carcinoma Trials Group (AHCC) Randomised Controlled Study Comparing Sorafenib and
SIR-Spheres® Y-90 resin microspheres in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) Expected in 2017
BTG plc, a specialist healthcare company, announced that it has entered into an agreement to acquire Galil Medical, a leading provider of cryoablation products for the treatment and palliative care of kidney and other cancers.
Abbott and St. Jude Medical, Inc. announced a definitive agreement for Abbott to acquire St. Jude Medical, creating a premier medical device leader with top positions in high-growth cardiovascular markets, including atrial fibrillation, structural heart and heart failure as well as a leading position in the high-growth neuromodulation market.
Sirtex announced today that the UK National Institute for Health and Care Excellence (NICE) has issued a new Medtech Innovation Briefing (MIB) stating that NHS doctors and commissioners may consider SIR-Spheres Y-90 resin microspheres as an alternative to standard therapy with trans-arterial chemoembolization (TACE) or sorafenib in the treatment of patients with inoperable primary liver cancer (hepatocellular carcinoma or HCC).
Sirtex (ASX:SRX) announced that the Netherlands Healthcare Institute, Zorginstituut Nederland (ZIN), has agreed to reimburse Selective Internal Radiation Therapy (SIRT) for patients with colorectal liver metastases who have failed on or are intolerant to prior chemotherapy. The ZIN based its decision on clinical evidence of the efficacy and safety of SIR-Spheres® Y-90 resin microspheres for treating this patient group.
Palliative Group of SORAMIC Study on Treatment of Locally Advanced Primary Liver Cancer with SIR-Spheres® Y-90 resin microspheres followed by Sorafenib Reaches 420-patient Enrolment Target
Sirtex Medical Limited announced that the results of the SIRFLOX study with SIR-Spheres Y-90 resin microspheres have been published on-line in the Journal of Clinical Oncology (JCO), the leading peer-reviewed publication of the American Society of Clinical Oncology (ASCO).