The repositionable aortic valve system allows to improve the functioning of the aortic valve in symptomatic patients with severe calcified aortic conestenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2 / m2) and high risk for a conventional surgical valvular replacement.
“We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
The repositionable aortic valve system allows to improve the functioning of the aortic valve in symptomatic patients with severe calcified aortic stenosis (aortic aortic area [AVA] of <1.0 cm2 or index of <0.6 cm2 / m2) and high risk for a substitution Conventional surgical valvular.
H749LTV230, H749LTV250, H749LTV270, H749LTVR3CL230, H749LTVR3CL250 and H749LTVR3CL270, specific batches.
Description du dispositif
The repositionable aortic valve system allows to improve the functioning of the aortic valve in symptomatic patients with severe calcified aortic stenosis (aortic aortic area [AVA] of <1.0 cm2 or index of <0.6 cm2 / m2) and high risk for a substitution Conventional surgical valvular.