Thoratec reports first human implant in HeartMate III CE Mark trial

US-based Thoratec reported that the first patient was implanted with its HeartMate III, a centrifugal-flow chronic left ventricular assist system, in a CE Mark clinical trial for the device.

The first human implant of HeartMate III has been carried out at the Hannover Medical School , Germany, which marked the first patient enrolled in the trial.

Around 50 patients are expected to be enrolled in the HeartMate III CE Mark clinical trial at nine sites in Europe, Australia and Canada.

Covidien introduces Pipeline Flex embolisation device in Europe


Ireland-based Covidien introduced its Pipeline Flex embolisation device in Europe, intended for the endovascular embolisation of cerebral aneurysms.

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The launch further strengthens the company's broad line of neurovascular products for treatment of unruptured brain aneurysms.

The minimally invasive device, which secured CE Mark approval earlier this year, has been designed to divert blood flow away from an aneurysm.

CHUV initiates Cerament |G Bone Healing study

Sweden-based Bonesupport announced that the Centre Hospitalier Universitaire Vaudois (CHUV) in Switzerland initiated the Cerament |G Bone Healing study, designed to investigate absorption and bone in-growth of Cerament|G in one-stage surgical revisions of infections.

The Cerament|G Bone Healing study will follow patients for one-year post surgery. CT verified Cerament|G absorption and new bone in-growth are primary endpoints of the study.

Secondary and safety endpoints of the study are bone healing, post-operative infections and serum levels of gentamicin.

PowerVision completes $30m Series D financing round for FluidVision lens development

US-based medical device company PowerVision announced the completion of a $30m Series D financing round to fund development of its FluidVision accommodating intraocular lens.

In the Series D financing round, new investors Aisling Capital and Correlation Venture Partners, as well as existing investor, Venrock, added $10m to the $20m closing earlier 2014 from PowerVision's existing investors.

PowerVision will use the proceeds of the funding to complete patient enrolment in the ongoing CE Mark study of the FluidVision accommodating intraocular lens.

ulrich medical introduces uCentum comprehensive posterior system in US


ulrich medical USA introduced the uCentum comprehensive posterior system in the US for minimally invasive (MIS) and open spinal fusion applications.

uCentum is designed to provide immobilisation and stabilisation of spinal segments as an adjunct to fusion of the thoracic, lumbar and sacral spine (T1-S2).

The uCentum pedicle screw features a simple low profile tulip-head, top loading, cannulated, fenestrated and optimised thread design to address increased purchase requirements of poor bone quality.

Medtronic agrees to acquire Covidien for $42.9bn

US-based medical technology firm Medtronic entered into a definitive agreement to acquire Ireland-based Covidien for $42.9bn.

The cash-and-stock transaction, valued at $93.22 per Covidien share, is subject to certain conditions, including approvals from shareholders of Medtronic and Covidien.

The proposed transaction requires regulatory clearances in the US, EU, China and certain other countries. It is expected to be completed in the fourth quarter of 2014 or early 2015.

TriReme Medical gets FDA approval for Chocolate PTCA balloon catheter

QT Vascular's US subsidiary TriReme Medical received US Food and Drug Administration approval to use its Chocolate PTCA balloon catheter for dilatation of the stenotic portion of the coronary artery or bypass graft stenosis.

The Chocolate PTCA is currently being used for treating patients with vascular disease in their legs and will now be used in improving myocardial perfusion.

Columbia University Center for Interventional Vascular Therapy director Martin Leon said: "It leverages the strong clinical outcomes and low rates of dissections of the Chocolate PTA balloon catheter, while providing an important new tool that could be now used in coronary arteries."

MedImmune and Ventana partner on custom assay for clinical trials


AstraZeneca's global biologics R&D arm MedImmune and Ventana Medical Systems (Ventana), a member of the Roche Group, are jointly developing a PD-L1 (SP263) immunohistochemistry assay to enrol patients in clinical trials for MedImmune's MEDI4736 anti-PD-L1 therapy for treating non-small cell lung carcinoma (NSCLC).

The development includes the recently started MEDI4736 ATLANTIC trial, which will enrol only patients who express PD-L1 as determined by the Ventana assay.

According to Ventana, the investigational, engineered, human monoclonal antibody 'MEDI4736' is directed against programmed cell death ligand 1 (PD-L1).