WHO Pharmaceuticals Newsletter 1999, No. 05&06
(1999; 20 pages)
Table des matières
Ouvrir ce répertoire et afficher son contenuRegulatory actions
Ouvrir ce répertoire et afficher son contenuDrug surveillance
Ouvrir ce répertoire et afficher son contenuNew developments
Fermer ce répertoireMedical devices
Afficher le documentBlood clot removal device: approved: United States of America.
Afficher le documentBreast imaging device: approved: United States of America.
Afficher le documentHaemodialysis tubing set: defective device recalled: Althin Medical, United States of America.
Afficher le documentHepatitis-C virus: first OTC home test approved: United States of America.
Afficher le documentTemporomandibular joint prostheses: premarket approval required: United States of America.
Ouvrir ce répertoire et afficher son contenuMedication errors
Ouvrir ce répertoire et afficher son contenuGeneral information
Ouvrir ce répertoire et afficher son contenuVeterinary medicine
 

Blood clot removal device: approved: United States of America.

The Food and Drug Administration has approved a new medical device for removing blood clots from blocked heart arteries or bypass grafts prior to angioplasty. The device will provide an alternative treatment to so-called clot-busting drugs, and will be particularly useful for patients in whom these drugs cannot be used.

The device: the AngioJet System manufactured by Possis Medical: is a coronary catheter system that shoots a jet of saline solution back into the tip of the catheter to suck out blood clots. Treatment with this device takes about one minute. Once the blood clot is removed the patient can then undergo angioplasty, a procedure intended to remove the arterial blockage.

The AngioJet System was previously approved to treat blood clots in dialysis grafts.

Reference: FDA Talk Paper T99-13, dated 15 March 1999.

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Dernière mise à jour: le 24 avril 2012