Shares of Boston Scientific (NYSE:BSX) rose nearly 7 percent in pre-market trading today after the FDA approved its Promus Element drug-eluting stent, inaugurating a head-to-head battle between two of the last giants left standing in the Stent Wars.
Drug-Eluting Stents
FDA investigates stent “shrinkage” in Boston Scientific’s Ion, Promus stents, others
The FDA is investigating reports that the thinner design of next-generation drug-eluting stents, including Boston Scientific’s (NYSE:BSX) Ion and Promus models, might be prone to deforming after implantation.
At least two studies and one case study presented at a recent cardiology conference reported incidents in which either a Boston Scientific Ion or Promus stent deformed after it was deployed inside a coronary artery.
Second study details stent “shrinkage”
More evidence has surfaced that the thinner design of next-generation coronary stents may be prone to crumpling after being deployed.
Dr. Cindy Grines, editor of the Journal of Interventional Cardiology, details a case in the journal’s October issue involving "marked shortening, deformation and accordion of the Ion coronary stent," something she hasn’t seen before in 25 years of practicing cardiology.
The stent involved in the case shortened by about 35 percent, Grines wrote.
TCT 2011: Three ways to spur U.S. medical innovation
The U.S. medical device arena is in danger of ceding the throne to countries with friendlier regulatory environments but the system is not irreparable, Dr. Martin Leon said during a lecture at this week’s Transcatheter Cardiovascular Therapeutics symposium in San Francisco.
Abbott wins FDA nod for Xience Prime stent
Can thinner stents handle the pressure?
Next-generation stents with thinner profiles and increased flexibility may not be as strong as their thicker forbears, according to researchers.
Thinner stents may have lower longitudinal strength or compressibility, an aspect of stent engineering that hasn’t traditionally held much significance in design.
Biotronik weathers a blow in “sham recall” case against Johnson & Johnson
A New York State Supreme Court judge dealt a blow to Biotronik AG’s case against Johnson & Johnson (NYSE:JNJ) subsidiary Conor Medsystems over their defunct deal to distribute a drug-eluting stent.
Erectile dysfunction: Medtronic’s ED stent proves successful when drugs fail
Men with erectile dysfunction may be able to turn to Medtronic Inc.’s (NYSE:MDT) drug-eluting pudendal stent when drugs fail to help, according to a preliminary study.
The Minneapolis-based medical device giant concluded an initial feasibility study of 30 men, and 30-day results found the drug-eluting stent safe and significantly effective in treating erectile dysfunction.
A unanimous thumbs up for Cook’s Zilver stent
After more than a year in the works, Cook Medical’s Zilver PTX stent got a unanimous boost from the FDA’s Circulatory Systems Devices Panel, putting it on track for U.S. market clearance in the next few months.
If approved, the device will be the first of its kind for the treatment of femoropopliteal arteries.
Cook Medical’s Zilver DES gets unanimous FDA panel vote
Cook Medical’s Zilver® PTX® Drug-Eluting Stent Technology Receives Unanimous Recommendation from FDA Advisory Committee
Medtronic, AtriCure and Cook to get panel review and PMA vote next month
The FDA’s circulatory system devices panel has Medtronic Inc. (NYSE:MDT), AtriCure Inc. (NSDQ:ATRC) and Cook Medical in its sights for panel review next month.
Medtronic and AtriCure are both hoping to get the panel’s nod for cardiac ablation devices, and Cook is working toward clearance for its drug-eluting stent.