The FDA today released an update on Baxter‘s (NYSE:BAX) voluntary recall of its Vascu-Guard peripheral vascular patch, saying that it is working with the company but that neither group has discovered a root cause for the issues, which led to a number of adverse events and 3 potential patient deaths. The Vascu-Guard patch is designed […]
Vascular
Delcath raises $2m in Series B stock sale
Delcath Systems (NSDQ:DCTH) has raised $2 million after selling 2,360 shares of Series B preferred stock at $1,000 per share to unnamed institutional investors, according to a regulatory filing. The company wrote that it plans to use the proceeds for general corporate purposes. Get the full story at our sister site, Drug Delivery Business News.
Biotronik touts Pulsar-18 self expanding stent trial data
Biotronik today released results from the Bioflex-I pivotal clinical trial of its Pulsar-18 self-expanding stent designed for treating patients with peripheral artery disease, touting high rates of freedom from major adverse events and primary patency. The company claims the Pulsar-18, which won FDA clearance in March, is the only approved superficial femoral artery self-expanding stent with […]
SteadyMed seeks FDA nod for Trevyent drug-device combo
SteadyMed (NSDQ:STDY) said today that it submitted a new drug application to the FDA for its drug-device pulmonary arterial hypertension therapy. The San Ramon, Calif.-based company’s lead product candidate is a combination of treprostinil and the PatchPump prefilled, disposable infusion system. Get the full story at our sister site, Drug Delivery Business News.
Bio2 touts pivotal data on Angel catheter-filter combo
Bio2 Medical touted data yesterday from the pivotal study of its Angel catheter in 163 critically ill patients with high risk of acute pulmonary embolism and contraindications to anticoagulation. The study met its safety endpoints and demonstrated a significant reduction in clinically significant and fatal pulmonary embolism, according to the company. The trial evaluated patients […]
Philips to pay $2B for Spectranetics, plans $1.7B share buyback
Royal Philips (NYSE:PHG) and Spectranetics (NSDQ:SPNC) said today that they agreed to a deal worth more than $2 billion that will see the Dutch healthcare giant take over the U.S. medical device maker. The $38.50-per-share deal values Spectranetics at $2.16 billion (€1.9 billion), including cash and debt, and is a 27% premium on SPNC’s $30.40 closing price […]
Aortica raises $1m, looks for $4m more
Aortica has raised $1 million in a new round of mixed financing, according to an SEC filing posted this week. Money in the round comes from 11 unnamed investors, with the 1st sale recorded on June 13 this year. The company is looking for an additional $3 million in the round before closing it, according […]
Teleflex says Venture Cath recall is FDA Class I
Teleflex (NYSE:TFX) subsidiary Vascular Solutions today updated on a voluntary recall of its Venture Catheters over issues with excess material on the devices, saying that the FDA labeled it as a Class I recall, it’s most serious designation for recalls. Class I recall designations, the FDA’s most serious classification of recall, are used when there is a […]
TriReme Medical touts Chocolate Heart drug-coated balloon data
QT Vascular subsidiary TriReme Medical touted angiographic data today from a 24-month follow-up of patients treated with its Chocolate Heart drug-coated balloon. The Chocolate Heart device is a paclitaxel-coated version of the company’s Chocolate coronary balloon that is commercially available in the U.S. The combo therapy was designed to reduce the incidence of repeat procedures […]
Reva closes $35m financing round
Reva Medical (ASX:RVA) said today that it closed the 2nd tranche of its $34.6 million financing round. The company issued $47.1 million convertible notes, 2,119,500 options for the purchase of common stock and repurchased $12.5 million of its common stock from 1 unnamed investor. The San Diego, Calif.-based company’s 1st commercial product is its Fantom sirolimus-eluting […]
Study: Induced pluripotent stem cells could yield accurate models for vascular disease
Smooth muscle and vascular endothelial cells induced from pluripotent stem cells could help model rare vascular diseases, according to a study published in Stem Cells Translational Medicine. Vascular diseases are tricky to study because they are hard to model and human tissue samples are scarce. An appropriate model for real blood vessels could enable researchers to […]