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 […]
Cardiovascular
InCarda Therapeutics raises $42m for inhaled atrial fibrillation drug
InCarda Therapeutics said today that it raised $42 million in an oversubscribed Series B financing round led by Sofinnova and HealthCap. Proceeds from the round are slated to support a Phase II trial of the company’s inhaled paroxysmal atrial fibrillation drug, InRhythm. Traditional therapies for PAF include oral antiarrhythmic drugs or acute hospital procedures. InCarda’s […]
TCT 2018: Boston Scientific wins FDA nod for drug-eluting vascular stent
On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia. The device, which is designed for the treatment of peripheral artery disease, uses a drug-polymer combination to deliver paclitaxel over the course of a year. “Over the past decade, we’ve […]
Mylan launches generic Brevibloc heart injection
Mylan (NSDQ:MYL) said today that it launched a generic version of Baxter‘s (NYSE:BAX) Brevibloc heart drug in the U.S. The company’s injectable product, esmolol hydrochloride in sodium chloride, will be offered in single-dose plastic bags, according to Mylan. The FDA approved Mylan’s drug for the short-term treatment of control of ventricular rate in supraventricular tachycardia, including […]
Medtronic launches one-month DAPT study for drug-eluting stent in U.S., Japan
Medtronic (NYSE:MDT) said today that it’s launching a study in the U.S. and Japan to evaluate dual antiplatelet therapy in high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent during percutaneous coronary intervention. The company’s Onyx One Clear study is one of the first designed to assess the risk of cardiac death and stent […]
Boston Scientific launches trial for drug-eluting peripheral stent
Boston Scientific (NYSE:BSX) said last week that it enrolled the first patient in a pivotal trial to evaluate its below-the-knee drug-eluting stent in patients with critical limb ischemia. The peripheral stent is the first of its kind to undergo the FDA’s breakthrough device program, according to the medtech giant. Roughly 17 million people in the U.S. […]
MicroPort’s drug-eluting stent performs well in European study
MicroPort Scientific’s Firehawk rapamycin target eluting coronary stent performed comparably to Abbott’s Xience stent family in a study just published in The Lancet. The TARGET AC multi-center, randomized controlled trial enrolled 1,653 patients at 21 clinical study sites in Europe. Firehawk met the trial’s non-inferiority primary endpoint of target lesion failure rate at 12 months of 6.1% versus […]
BioCardia touts preliminary data from heart failure trial
BioCardia (OTC:BCDA) touted data today from the first 10 patients treated in its Phase III CardiAmp heart failure trial. The company’s investigational therapy uses a patient’s bone marrow cells to trigger the body’s natural ability to heal itself, according to BioCardia. These data are the first to be published from any pivotal trial of a stem […]
The future of Abbott’s electrophysiology business
At DeviceTalks Minnesota 2018, medtech veteran Michael Pederson provided an inside look at the Abbott-St. Jude Medical merger and what’s ahead for Abbott’s cardiovascular technologies. Pederson tracked his career from a formative stint at HP to his current role as SVP of cardiac arrhythmias and heart failure at Abbott (NYSE:ABT). Get the full story at our sister […]
Medtech stories we missed this week: July 27, 2018
From the FDA clearing LifeSignal’s wireless ECG to Zavation receiving FDA clearance for its expandable corpectomy cage, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears LifeSignal’s wireless ECG LifeSignals announced in a July 26 press releasethat it has received FDA clearance for its wireless LP1100 Life Signal […]