A study comparing drug-eluting stents made by Biotronik, Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) found no statistically significant difference on target vessel failure or stent thrombosis after three years. The 3,514-patient Bio-Resort trial compared Biotronik’s Orsiro biodegradable sirolimus-eluting stent, Medtronic’s thin-strut zotarolimus-eluting Resolute Integrity stent and the Synergy biodegradable everolimus-eluting stent. Three-year results for some 3,393 […]
Cardiovascular
B. Braun wins breakthrough nod for drug-coated balloon catheter
The FDA has granted B. Braun Interventional Systems breakthrough device designation for the company’s SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter for the treatment of coronary in-stent restenosis (ISR). The designation follows 10 years of clinical studies on the SeQuent Please drug-coated PTCA catheters, with data reported in peer-reviewed articles, according to the […]
EuroPCR 2019: Elixir Medical touts DynamX
Elixir Medical touted clinical and imaging results from a study of its DynamX drug-eluting stent, which is designed to restore normal pulsatility and adaptive remodeling in blood vessels after treating a coronary lesion. DynamX, introduced in 2017 at the annual Transcatheter Cardiovascular Therapeutics meeting, is a cobalt-chromium stent with a biodegradable polymer coating that releases […]
FDA updates docs on review of paclitaxel devices for PAD
The FDA said last week that its preliminary review of long-term follow-up data found a “potentially concerning signal” of increased long-term mortality in people with peripheral artery disease who were treated with paclitaxel-coated devices compared to those treated with bare devices. In a letter to healthcare providers, the U.S. regulatory agency reported that there was […]
Medtronic updates on corrected safety analysis for paclitaxel-coated balloon
Medtronic (NYSE:MDT) said last week that a revised safety analysis of its In.Pact drug-coated balloon has been accepted by the Journal of the American College of Cardiology. Last month, the medtech titan reported that a programming error inadvertently caused mortality data to be omitted from a statistical analysis involving the company’s paclitaxel-coated balloon. The announcement came […]
Late mortality rates ‘inadvertently reversed’ in 5-year study of paclitaxel-eluting stent
The journal Circulation said this week that the all-cause mortality rates in a study comparing a paclitaxel stent and percutaneous transluminal angioplasty in people with peripheral artery disease were “inadvertently reversed” by the authors. In the first version of the paper, originally published in 2016, researchers reported that the 5-year all-cause mortality rate for people […]
Medtronic: Patient deaths left out of paclitaxel-coated balloon analysis
Medtronic (NYSE:MDT) said last week that it inadvertently omitted an undisclosed number of patient deaths from recent studies of its paclitaxel-coated balloons. The company noted that the mistake ultimately does not affect the conclusion that there was no statistically significant difference in all-cause mortality between its In.Pact Admiral drug-coated balloon and plain balloon angioplasty at five […]
West Pharma’s SmartDose will deliver scPharmaceuticals’ edema drug
scPharmaceuticals’ (NSDQ:SCPH) has signed a development agreement to incorporate West Pharmaceutical Services’ (NYSE:WST) SmartDose drug delivery system with Furoscix, a drug that scPharmaceuticals developed to treat edema in heart failure patients. Burlington, Mass.-based scPharmaceuticals recently completed preliminary feasibility studies of the drug-device combination. The testing included drug stability in the pre-filled cartridge, drug compatibility, and […]
Johnson & Johnson, Apple ink collab for AFib study
Johnson & Johnson‘s (NYSE:JNJ) Janssen and Apple (NSDQ:AAPL) said today that the two companies inked a deal to study if an app from J&J in combination with the Apple Watch’s ECG app and irregular rhythm notifications can improve outcomes for people living with atrial fibrillation. The study is slated to measure the impact of the Apple Watch […]
Amgen touts lowered prices for Repatha delivery devices
Amgen (NSDQ:AMGN) said today that it lowered the list prices of the drug-delivery devices for its cholesterol drug, Repatha, to $5,850 per year. The Thousand Oaks, Calif.-based company touted the 60% discount as a way to boost patient affordability and accessibility. The Repatha SureClick autoinjector, which Amgen said is the most commonly used delivery device for […]
