Boston Scientific Relying On Primo In Wake Of NIR-On-Ranger With SOX Recall
This article was originally published in The Gray Sheet
Executive Summary
Boston Scientific expects to generate $150-175 mil. U.S. stent revenue in the fourth quarter despite the firm's Oct. 5 voluntary recall of the NIR-On-Ranger coronary stent system with the SOX securing system.
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Boston Scientific settles with DoJ
The Department of Justice will drop civil charges against Boston Scientific for product adulteration and misbranding after the firm pays $74 mil. in damages. The complaint concerns Boston Scientific's continued distribution of the Nir-On Ranger with Sox coronary stent delivery systems in 1998 after the firm learned that the stent-deploying balloons could leak or burst at pressures below those specified on the labeling. The Natick, Mass. firm continued to distribute the stents even after running internal tests, consulting outside counsel and convening a field action committee to address reports of balloon failure. Following talks with FDA, the firm began a Class II recall in October 1998 (1"The Gray Sheet" Oct. 12, 1998, p. 28). The company "took a risk" that the flaws it detected in-house "would not occur in the marketplace," U.S. Attorney Michael Sullivan observed. However, he added that "this case does not involve any risk to [patients]." In settling, Boston Scientific claims no liability. The firm no longer sells products on the Nir platform...
Boston Scientific settles with DoJ
The Department of Justice will drop civil charges against Boston Scientific for product adulteration and misbranding after the firm pays $74 mil. in damages. The complaint concerns Boston Scientific's continued distribution of the Nir-On Ranger with Sox coronary stent delivery systems in 1998 after the firm learned that the stent-deploying balloons could leak or burst at pressures below those specified on the labeling. The Natick, Mass. firm continued to distribute the stents even after running internal tests, consulting outside counsel and convening a field action committee to address reports of balloon failure. Following talks with FDA, the firm began a Class II recall in October 1998 (1"The Gray Sheet" Oct. 12, 1998, p. 28). The company "took a risk" that the flaws it detected in-house "would not occur in the marketplace," U.S. Attorney Michael Sullivan observed. However, he added that "this case does not involve any risk to [patients]." In settling, Boston Scientific claims no liability. The firm no longer sells products on the Nir platform...
Boston Scientific NIR Stent With SOX Inventory Sufficient For Relaunch
Boston Scientific has sufficient inventory of its modified NIR coronary stent with the SOX delivery system to support relaunch the week of March 20, the firm reported March 16 in announcing FDA approval of a premarket approval application supplement. Product manufacturing and shipments to Japan commenced earlier this year following approval by the Japanese Ministry of Health in December.