This product family is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices, may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart. The filing for approval of this product family follows the FDA approval of BioCardia’s Helix biotherapeutic delivery Morph DNA guide system and its Avance transseptal steerable introducer, both of which incorporate Morph DNA technology.
该产品系列旨在提供一种途径，通过该途径可以将医疗器械（例如球囊扩张导管，导丝或其他治疗装置）引入心脏的外周脉管系统或腔室和冠状脉管系统。该产品系列的申请获得FDA批准后，BioCardia的Helix biotherapeutic delivery Morph DNA guide system及其Avance transseptal steerable Introductor均采用了Morph DNA技术。
