Integrated Endoscopy said today it tapped Brad Sharp as its new prez & CEO, as well as joining the company’s board. The company said it is making the move with Sharp in preparation of the launch of its Nevis single-use arthroscope, which is slated for early 2017. The company said it also named Rob Cripe […]
Stentys wins CE Mark for Xposition S self-apposing coronary stent
Stentys SA (EPA:STNT) said today it won CE Mark approval in the European Union for its self-apposing coronary Xposition S sirolimus-eluting stent, claiming it to be the “world’s 1st and only self-apposing coronary stent.” The approval came based upon results from a study of the device published last year in the journal Catheterization and Cardiovascular […]
Stentys raises $13.9m to fund Euro expansion
Stentys SA (EPA:STNT) said last week it raised $13.9 million through the sale of 5.6 million new shares to support its development and expansion. The company said it will use the funds to expand in “European centers” by extending its distributor network and by obtaining regulatory approval in countries outside the CE Mark system. Stentys […]
Stentys touts data from head-to-head stent trial against MDT’s Resolute
Stentys SA (EPA:STNT) today touted the results of its Apposition IV trial comparing the company’s Stentys self-apposing sirolimus-eluting coronary stent to Medtronic‘s (NYSE:MDT) Resolute stent in patients with ST-segment elevation myocardial infarction. Results from the study were published in the journal EuroIntervention this month. Stentys calls its suite of Apposition stents the “world’s 1st and only self-apposing […]
TCT 2015 Roundup: St. Jude Medical’s new HeartMate PHP pump
St. Jude Medical (NYSE:STJ) said today that its newly acquired HeartMate PHP heart pump met its safety and efficacy endpoints in the Shield I trial used to back its CE Mark approval last summer. The results from Shield I’s 1st 30 patients led to the CE Mark nod in July. Today St. Jude said data from 46 subjects […]
Stentys wins CE Mark for BTK drug-eluting stent
Stentys SA (EPA:STNT) said yesterday it won CE Mark approval in the European Union for its drug-eluting stent for treatments of below-the-knee arteries. The self-expanding, drug-eluting stent is the 1st of its kind with regulatory approval in Europe for BTK arteries, according to the French company. “Entering the peripheral arterial disease market, which, outside of […]
FDA approves STJ’s MRI-safe SCS device | Regulatory news for the week of May 4, 2015
FDA approves MRI-safe SCS device from St. Jude Medical
April 30, 2015 by Brad Perriello
Surprise CE Mark for Stentys Xposition S stent
Stentys this week said it won a CE Mark ahead of schedule for its latest self-apposing coronary stent, a product that will be used with delivery system technology it acquired last June.
Micell launches all-comers trial for absorbable-polymer stent
Stentys closes $1.4M acquisition of Cappella’s Peel Away stent delivery device
Stentys said it’s closed the deal on the €1 million ($1.4 million) deal to acquire the Peel Away stent delivery system.
The cash-and-stock deal is the 1st strategic acquisition for Stentys, which makes a line of bare-metal and drug-eluting coronary stents.
Stentys to acquire Cappella Peel Away’s stent delivery device
Stentys said it agreed to pay an unspecified amount to acquire Cappella Peel Away and its "novel" stent delivery system.
Princeton, N.J.- and Paris-based Stentys said it plans to integrate the technology into the delivery system for its line of bare-metal and drug-eluting stents, aiming to have the new system on the market in 2015.