MitrAssist Medical has obtained ISO 13485:2003 certification for the design of implantable mitral valve prostheses. By using a minimally invasive procedure, the mitral valve prosthesis is delivered via a small-diameter catheter, thus ...
Tags: MitrAssist, ISO certification, mitral valve prostheses
Svelte Medical Systems has commenced First Assessment of the Acrobat Stenting Technique European Post-Market Registry (FAASTER) study. The multi-center registry study, which will enroll up to 1,500 patients, is designed to evaluate the ...
Tags: Svelte Medical Systems, FAASTER, FAASTER study, registry study
Teleflex Incorporated, a provider of cardiovascular solutions, has introduced new Arrow FlexTip Plus closed epidural catheter. The new Arrow FlexTip Plus closed device is a multi-port epidural catheter designed for anesthesia providers to ...
Tags: Teleflex Incorporated, Arrow FlexTip Plus, epidural catheter, Teleflex
The US Food and Drug Administration (FDA) has cleared 510(k) pre-marketing notification application (PMA) of ETView Medical's Viva EB Endobronchial blocker. Viva EB comprises a sterile, single-use, steerable, balloon tipped catheter ...
Tags: FDA, Viva EB, Endobronchial blocker, medical device
CardioKinetix has obtained CE mark approval for its full size matrix of its percutaneous ventricular restoration device to treat patients with ischemic heart failure. The Parachute ventricular partitioning device uses a small catheter ...
Tags: CE Mark, heart failure, medical device
Blockade Medical has obtained CE mark for its Barricade coil system, designed to remove or endovascularly occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. The Barricade coil system, which includes ...
Tags: Blockade Medical, Barricade coil system, platinum microcoils
ConvaTec has unveiled enhanced Flexi-Seal Signal fecal management system (FMS) in the US. Flexi-Seal FMS is indicated for patients with little or no bowel control and liquid or semi-liquid stool, and can be used for up to 29 consecutive ...
Tags: ConvaTec, Flexi-Seal FMS, sampling port, Healthy rectal mucosa
AngioScore has begun patient enrollment in a first-in-human (FIH) study of its CardioSculpt Valvuloplasty Scoring Balloon catheter, designed to treat patients with symptomatic critical aortic valve stenosis. CardioSculpt catheter, which ...
Tags: CardioSculpt Valvuloplasty Scoring Balloon catheter, catheter
HealthTrust Purchasing Group has awarded a contract to AngioDynamics to provide its vascular access products. Vascular access products include DuraMax chronic dialysis catheter, DuraFlow, DuraFlow 2 and EvenMore chronic hemodialysis ...
Tags: vascular access products, DuraMax chronic dialysis catheter
Helix Medical, a division of the Freudenberg Group, has completed the acquisition of MedVenture Technology for an undisclosed sum. MedVenture's commercial products include minimally invasive surgical and catheter-based devices used in ...
Teleflex's Arrow FlexTip Plus Closed Tip, multi-port epidural catheter has been granted 510(k) clearance by the US Food and Drug Administration (FDA). The Arrow FlexTip Plus Closed Tip catheter utilizes the same technology of the ...
BioCardia has announced positive results from a Phase I/II trial of its Helical Infusion system, designed to deliver donor's (allogeneic) or treated patient's (autologous) adult mesenchymal stem cells (MSCs) via transendocardial stem cell ...
Tags: Helical Infusion system, stem cell injection, device, Infusion System
C. R. Bard's Lutonix technology center has completed enrolling patients in its pivotal investigational device exemption (IDE) LEVANT 2 trial, designed to evaluate Lutonix drug coated PTA dilatation catheter (DCB) as a treatment for ...
Tags: pivotal investigational device, drug coated PTA dilatation catheter
Tangent Medical has gained FDA 510(k) clearance for the NovaCath Secure IV Catheter System designed to address peripheral IV challenges including catheter stabilization, healthcare worker safety, tubing management and patient comfort. ...
Tags: FDA, Catheter System, medical device, clinical technology
The US Food and Drug Administration (FDA) has granted 510(k) approval to Avery Dennison Medical Solutions' new non-cytotoxic, grade 0 profile transparent wound film dressing, designed to treat catheter-related blood stream infections. ...
Tags: FDA, wound film dressing, clinical product, clinical application