May's top stories: Cinven-Labco €1.2bn deal, Abbott’s companion diagnostics
Cinven has agreed to acquire French medical diagnostics provider Labco for €1.2bn, Dassault Systèmes makes the first commercial, physics-based simulated heart available and Abbott will develop companion diagnostics for AstraZeneca’s asthma drug, tralokinumab. Medicaldevice-network.com wraps up key headlines from May.
British private equity firm Cinven signed an agreement to acquire Labco from a consortium of investors for €1.2bn.
Headquartered in France, Labco conducts clinical tests and delivers results to prescribing doctors and patients, while offering assistance with the interpretation of clinical results through in-house laboratory doctors.
Founded in 2003, the group operates a network of more than 160 routine and specialist laboratories and 1,000 collection centres across seven European countries, including France, Spain, Italy, Portugal, Belgium and the UK.
Dassault Systèmes announced plans to commercially release the first simulated human heart from its Living Heart Project on 29 May.
Developed using Dassault's 3DEXPERIENCE platform's realistic simulation applications, the high-fidelity 3D simulator of a four-chamber human heart will enable device manufacturers, researchers and medical professionals to perform virtual tests and visualise the heart's response in ways that are not possible with legacy physical testing.
Representing a baseline healthy heart, the model comprises well-defined anatomic details of the heart and proximal vasculature such as the aortic arch, pulmonary artery and superior vena cava, and can be used to study congenital defects or heart disease by altering the shape and tissue properties in an easy-to-use software editor.
AstraZeneca signed an agreement with Abbott to develop companion diagnostic tests for identification of patients with severe asthma who may benefit from the investigational biological therapy, tralokinumab.
Under the agreement, Abbott will develop and commercialise diagnostic tests to measure serum levels of the proteins periostin and dipeptidyl peptidase-4 (DPP4) that have been identified as potential predictive biomarkers of up-regulated IL-13 in severe asthma.
Tests are scheduled to be developed in accordance with AstraZeneca's Phase III trial of tralokinumab, a potential treatment developed by the company's biologics research and development unit, MedImmune, for patients with severe, inadequately controlled asthma.
Royal Philips launched a new 3D navigation system, VesselNavigator, designed to guide the minimally invasive treatment of patients with vascular diseases such as aortic aneurysms.
The new catheter navigation solution can be used in conjunction with its interventional x-ray systems, which helps to improve precision and accuracy of stent placement and reduces contrast medium usage.
The system provides minimally invasive treatment options for patients who were previously unable to benefit from new image-guided intervention techniques.
Kallistem successfully produced fully formed human spermatozoa in-vitro, using patient testicular biopsies containing only immature germ cells, also called spermatogonia.
Spermatogenesis is a complex physiological process covering production of spermatozoa from male primordial germ cells through mitosis and meiosis and takes 72 days in-vivo.
Leveraging two innovative, patented technologies that can meet current regulatory standards, the company completed the process, which a number of teams worldwide have been trying to achieve for more than 15 years.
The US Food and Drug Administration (FDA) granted approval for St Jude Medical's Protégé MRI spinal cord stimulation (SCS) system.
The company also secured FDA approval for MRI compatibility of its 60cm Octrode percutaneous leads, which can be used for MR-conditional labelling with the Protégé MRI system.
According to the company, the Protégé MRI system is the smallest MR-conditional SCS implantable pulse generator (IPG) available in the US and the only upgradeable IPG, which helps patients to safely undergo head and extremity MRI scans.
Medtronic was authorised by US Food and Drug Administration (FDA) to use the Arctic Front Advance ST Cryoablation Catheter for the treatment of patients with drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation (AF).
In addition, the Cryoballoon secured CE Mark for the treatment of patients with AF in Europe.
The Arctic Front Advance ST Cryoballoon is designed for use in a minimally invasive procedure to isolate pulmonary veins, which are a source of erratic electrical signals that cause AF.
The US Food and Drug Administration (FDA) granted 510(k) clearance for Sonendo's third generation Multisonic Ultracleaning system for root canal therapy.
Released through the FDA's Center for Devices and Radiological Health, the clearance expands the use for the GentleWave system to include anterior and premolar cases, apart from the current molar indication.
The system is designed to be a minimally-invasive, disruptive technology that leverages multiple wavelengths of sound to clean the entire root canal system simultaneously.