The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol).
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100518
Boston Scientific Innova Stent Recall Lawsuit. Boston Scientific is now recalling a new stent for leg arteries after numerous complaints of no deployment or partial deployment were received by the FDA. This fundamental defect may result in vessel wall injury and / or emergency surgery to remove the partially deployed stent.
https://www.schmidtandclark.com/boston-scientific-innova-stent-recall
June 28, 2011 – This week, the U.S. Food & Drug Administration (FDA) announced that Boston Scientific is recalling its Innova self-expanding stent system because the products may fail to deploy or only partially deploy during an operation.
https://www.schmidtandclark.com/boston-scientific-innova-stent-recall
Quality of Life [ Time Frame: 12 months ] Improved Quality of Life assessed by the SF-36 Health Survey. The validated SF-36 Survey, where scores are calibrated so that 50 is the average score or norm, was utilized (scores ranging from 0, worst possible health to 100, best possible health).
https://clinicaltrials.gov/ct2/show/NCT01292928
Subsequent to the receipt of the sanction, the company has initiated a full commercial launch of the Innova Stent System in the U.S. Boston Scientific introduced the Innova Stent System to offer advanced treatment to patients suffering from peripheral artery disease (PAD). PAD is a common circulatory disorder, caused by narrowing or blockages in the arteries of one’s limbs, specifically the superficial femoral artery (SFA) or proximal popliteal artery (PPA).
https://www.zacks.com/stock/news/187144/boston-scientifics-innova-stent-system-wins-fda-approval
The Innova Self-Expanding Stent is available in a variety of diameters and lengths. The delivery system is also offered in two working lengths (75 cm and 130 cm). The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100518
Co-Primary Efficacy Endpoints [ Time Frame: 12 months ] The co-primary efficacy endpoints assess vessel primary patency at 12 months post-procedure. The co-primary efficacy analysis (1) will assess vessel primary patency in stented segments intended to be treated with core matrix stents (20 to 150 mm). The co-primary efficacy analysis (2) will assess vessel primary patency in stented segments intended to be treated with the entire stent matrix (20 to 200 mm).
https://clinicaltrials.gov/ct2/show/NCT01292928
Boston Scientific Corporation is conducting a recall of the Innova Self-Expanding Stent System because they have received 6 complaints involving no deployment/partial deployment of the Innova Stent.
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=100518
FDA Announces Recall for Boston Scientific Stent System. June 20, 2011 — Boston Scientific Corporation has recalled its Innova Self-Expanding Stent System for a potentially life-threatening defect, the US Food and Drug Administration (FDA) announced June 17.
http://www.medscape.com/viewarticle/744924
This type of failure may result in vessel wall injury, increased procedure time, and/or emergency surgery to remove the partially deployed stent, the FDA said. The recall does not affect stents that have already been implanted, as the risk occurs during delivery of the stent.
http://www.medscape.com/viewarticle/744924
what type of stent is innova
Self-Expanding is a type of stent in the Innova.