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Stentys

Integrated Endoscopy names Sharp as prez & CEO | Personnel Moves November 15, 2016

November 15, 2016 By Fink Densford

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 […]

Filed Under: Business/Financial News Tagged With: Ancora Heart, Beaver-Visitec, Cynosure Inc., Integrated Endoscopy, Personnel Moves, RoundTable Healthcare Partners, Stentys

Stentys wins CE Mark for Xposition S self-apposing coronary stent

March 28, 2016 By Fink Densford

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Drug-Eluting Stents, Regulatory/Compliance, Stents Tagged With: Stentys

Stentys raises $13.9m to fund Euro expansion

March 7, 2016 By Fink Densford

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 […]

Filed Under: Business/Financial News, Stents Tagged With: Stentys

Stentys touts data from head-to-head stent trial against MDT’s Resolute

February 29, 2016 By Fink Densford

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Clinical Trials, Stents Tagged With: Stentys

TCT 2015 Roundup: St. Jude Medical’s new HeartMate PHP pump

October 14, 2015 By Brad Perriello

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 […]

Filed Under: Cardiovascular, Catheters, Clinical Trials Tagged With: Elixir Medical Corp., Micell Technologies Inc., Stentys, stjudemedical, TCT 2015, Tryton Medical Inc.

Stentys wins CE Mark for BTK drug-eluting stent

September 29, 2015 By Fink Densford

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 […]

Filed Under: Drug-Eluting Stents, Regulatory/Compliance, Stents, Vascular Tagged With: Stentys

FDA approves STJ’s MRI-safe SCS device | Regulatory news for the week of May 4, 2015

May 5, 2015 By MassDevice Contributors Network Leave a Comment

FDA approves MRI-safe SCS device from St. Jude Medical

April 30, 2015 by Brad Perriello

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: C.R. Bard, Capella Inc., CryoLife, Federal Trade Commission (FTC), Stentys, stjudemedical, Tornier Inc., wrightmedical

Surprise CE Mark for Stentys Xposition S stent

April 30, 2015 By Mark Hollmer Leave a Comment

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.

Filed Under: News Well, Regulatory/Compliance, Stents Tagged With: Capella Inc., CE Mark, Stentys

Micell launches all-comers trial for absorbable-polymer stent

March 23, 2015 By Brad Perriello Leave a Comment

Micell launches all-comers trial for absorbable-polymer stent

Filed Under: News Well Tagged With: Bioabsorbable Stents, Clinical Trials, Distribution, Micell Technologies Inc., Stentys

Stentys closes $1.4M acquisition of Cappella’s Peel Away stent delivery device

June 13, 2014 By Brad Perriello Leave a Comment

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.

Filed Under: Mergers & Acquisitions, News Well, Stents Tagged With: Cappella Medical, Stentys

Stentys to acquire Cappella Peel Away’s stent delivery device

June 4, 2014 By Brad Perriello Leave a Comment

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.

Filed Under: Mergers & Acquisitions, News Well, Stents Tagged With: Cappella Peel Away, Stentys

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