CorVascular has entered into a distribution agreement with Novarix. The IV-eye, developed and manufactured in the UK by Novarix, is a near infrared (NIR) vein imaging device designed to aid healthcare professionals in finding suitable peripheral veins for both cannulation and venipuncture.
Following Health Canada regulatory approval, BTG is to launch its polidocanol injectable foam (Varithena), a drug/device combination product used to treat varicose veins, in Canada. The product is intended for use in adults with clinically significant venous reflux as diagnosed by duplex ultrasound.
Bluegrass Vascular has announced that it is entering into a strategic relationship with Merit Medical. The agreement will streamline European distribution of the recently CE mark approved Surfacer inside-out access catheter system and will provide funding to support the company’s efforts to secure FDA clearance for product sales in the USA.
BTG has received Class III CE mark certification for DC Bead Lumi, the first commercially available radiopaque drug-eluting bead (DEB) in the EU which can be loaded with doxorubicin or irinotecan for the local treatment of tumours in patients with hepatocellular carcinoma and malignant colorectal cancer metastasised to the liver. According to a company release, for the first time, DC Bead Lumi provides real-time visible and lasting confirmation of bead location.
Medtronic has been granted CE mark approval for the HawkOne directional atherectomy system in a lower profile size for treating patients with peripheral artery disease. The new HawkOne 6 Fr 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. The HawkOne system is designed to remove plaque from the vessel wall and restore blood flow.
The final 12-month results of the Stellarex (Spectranetics) drug-coated balloon ILLUMENATE Global Study have found high primary patency and freedom from clinically driven target lesion revascularisation results.
Interim data presented at the 2017 Leipzig Interventional Course (LINC; 24-27 January, Leipzig, Germany) has demonstrated encouraging results for Biotronik’s dedicated lower limb intervention portfolio.
TVA Medical has provided clinical updates involving its everlinQ endoAVF system at the 2017 Leipzig Interventional Course (LINC; 24–17 January, Leipzig, Germany).
Medtronic has received an investigational device exemption (IDE) from the US Food and Drug Administration (FDA) to initiate a study of the In.Pact Admiral drug-coated balloon for a potential new indication in patients with end-stage renal disease.
Gore has announced that the Gore Viabahn VBX balloon expandable endoprosthesis has received US FDA approval for treatment of de novo or restenotic lesions found in iliac arteries, including lesions at the aortic bifurcation.
Cardiovascular systems (CSI) presented six-month data from its LIBERTY 360 degrees post-market study in a presentation at the 29th International Symposium on Endovascular Therapy (ISET; 4-8 February, Hollywood, USA). The study is evaluating the acute and long-term clinical and economic outcomes of peripheral vascular interventions in treating patients with symptomatic lower extremity peripheral artery disease.
Argon has announced that it has completed the sale of its Critical Care Unit including a manufacturing facility in Yishun, Singapore and related commercial operations in Europe and Japan, to Merit.
While drug-eluting devices, be they balloons or stents, use chemotherapeutic agents (usually paclitaxel) to reduce the build-up of scar tissue inside the arteries, a microinfusion device that applies the anti-inflammatory agent, dexamethasone, to the outside of arteries to enhance healing, is seeing largescale early positive results.
Barry Katzen, Miami, USA, announced the establishment of a new society, the Critical Limb Ischaemia (CLI) Global Society, whose mission is to improve quality of life by preventing amputations and death due to the condition.
Scott Trerotola presented the first release of eight-month data from the Lutonix AV IDE trial at the Leipzig Interventional Course (LINC; 24–27 January, Leipzig, Germany) and showed that drug-coated balloons (Lutonix 035 AV from Bard) are linked with a significantly higher target lesion patency and far fewer reinterventions to maintain this opening in a wide variety of failing arteriovenous fistulas than standard angioplasty.
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