dismiss

Clean Sweep Live Auction on Wed. May 1st. Click to view the full inventory

DOTmed Home MRI Oncology Ultrasound Molecular Imaging X-Ray Cardiology Health IT Business Affairs
News Home Parts & Service Operating Room CT Women's Health Proton Therapy Endoscopy HTMs Pediatrics
SEARCH
Endroit courant :
>
>
> This Story

Forward Printable StoryPrint Comment
advertisement

 

advertisement

 

Cardiology Homepage

Leading vascular surgeon presents comparative data analysis on EndoAVF procedures at Society of Interventional Radiology 2019

Intact Vascular’s Tack Endovascular System receives FDA approval

iSchemaView’s RAPID approved for use in the Kingdom of Saudi Arabia

Stryker launches LIFEPAK CR2 defibrillator with LIFELINKcentral AED program manager in the United States

Avinger (AVGR) announces receipt of FDA 510(k) clearance of Pantheris SV device

BIOTRONIK launches PK Papyrus covered coronary stent in the US

Insera earns CE Mark approval for cyclical-suction stroke thrombectomy platform, the CLEAR aspiration system

iSchemaView’s RAPID approved for use in Israel

Seisa Medical announces acquisition of Burpee MedSystems

Study finds lower death rates for TAVR centers that do more procedures

Cardiawave obtains clinical trial authorization for the world' first non-invasive treatment solution for aortic stenosis

Press releases may be edited for formatting or style
Press release • Paris, 3 April 2019 • Cardiawave, the MedTech company created following research conducted by the Institut Langevin and the Georges Pompidou European Hospital, announces that it has obtained the authorization to launch clinical trials for its non-invasive treatment solution for aortic stenosis. This announcement highlights the need for a solution to this unmet medical need which affects millions of patients.

A GROUND-BREAKING NEW THERAPY FOR CALCIFIC AORTIC STENOSIS

Story Continues Below Advertisement

Servicing GE Nuclear Medicine equipment with OEM trained engineers

We offer full service contracts, PM contracts, rapid response, time and material,camera relocation. Nuclear medicine equipment service provider since 1975. Click or call now for more information 800 96 NUMED



Cardiawave has developed a highly innovative technology, non-invasive therapy to treat Calcific Aortic Stenosis. It improves the opening of heavily calcified aortic valves by reducing the stiffness in the aortic valve tissue using high-energy, short pulses of ultrasound that are transmitted directly into the aortic valve from outside the body.

CLINICAL TRIALS: THE FIRST STEP TOWARDS A NEW TREATMENT FOR AORTIC STENOSIS

Authorization has now been granted by ethical committees and competent authorities (in France the Agency for the Safety of Medicines, ANSM) to begin clinical trials in France and the Netherlands, with imminent approval in Serbia as well. A trial in 10 patients will therefore commence shortly, with the patient inclusion process scheduled to end in the summer of this year.
This multi-center, international study is a collaborative project between three renowned centers: the Georges Pompidou European Hospital (HEGP) in Paris, France; the Amphia Hospital in Breda, the Netherlands; the Clinical Center of Serbia in Belgrade, Serbia. The trial will be coordinated by Professor Emmanuel Messas, cardiologist at the HEGP.

According to Benjamin Bertrand, CEO of Cardiawave: "The granting of these authorizations in several countries is recognition for the hard work of our teams and partners over the last few years, and it paves the way for a completely non-invasive treatment for this disease which affects an increasing number of patients due to an aging population. We are delighted to participate in this study in France, because the project has been predominantly funded and supported by French stakeholders in both public and private sectors".

In practical terms, the multi-disciplinary cardiovascular team (the "Heart Team") within these three investigative centers will initially determine the eligibility of patients and obtain their informed consent; a Case Review Committee will then confirm this eligibility and the patient can proceed to the treatment stage. By performing an echocardiogram before, during and after the therapy, the movements of the valve can be monitored and the affected areas can be precisely targeted with the therapeutic ultrasound pulses. Finally, a post-treatment evaluation will be scheduled at 1, 3, 6, 12 and 24 months to ensure patient safety and the efficacy of the therapy. A central laboratory (Cardialysis BV, Rotterdam, The Netherlands), acting in the capacity of an independent competent third-party, will objectively assess the condition of the patients' aortic valves at each time point.
  Pages: 1 - 2 >>

Cardiology Homepage


You Must Be Logged In To Post A Comment

Publicité
Développez la notoriété de votre marque
Enchères + Ventes Privées
Obtenir le meilleur prix
Acheter des équipement / pièces
Trouver le meilleur prix
Infos du jour
Lire Les dernières nouvelles
Annuaire
Consulter tous les utilisateurs DOTmed
Éthique concernant DOTmed
Voir notre programme d'éthique
L'or partie le programme de fournisseur
Recevoir des demandes PH
Programme de marchand de service d'or
Recevoir des demandes
Fournisseurs de soins de santé
Voir tous les outils des HCP (abréviation pour les professionnels de la santé)
Les travaux/Formation
Trouver / combler un poste
Parts Hunter +EasyPay
Obtenir des devis de pièces
Certification Récentes
Voir les utilisateurs récemment certifiés
Evaluation Récentes
Voir les utilisateurs récemment certifiés
Central de location
Louer de l’équipement à moindre prix
Vendre des équipements / pièces
Obtenir le maximum d'argent
Service le forum de techniciens
Trouver de l'aide et des conseils
Simple demande de propositions
Obtenir des devis pour des appareils
Expo Virtuelle
Trouver des services d'appareils
L'Access et l'utilisation de cet emplacement est sujet aux modalités et aux conditions du notre de nos MENTIONS LEGALES & DONNEES PERSONELLES
Propriété de et classe des propriétaires DOTmedà .com, inc. Copyright ©2001-2019 DOTmed.com, Inc.
TOUS DROITS RÉSERVÉS