QT Vascular said today that the FDA approved the company’s request to expand an on-going pivotal study of its Chocolate Touch drug-coated balloon to include the use of atherectomy for lesion preparation. The U.S. regulatory agency also approved the addition of subgroup analysis related to the use of atherectomy. The pivotal study of QT Vascular’s […]
BD beats The Street with Q2 results
Shares in Becton Dickinson (NYSE: BDX) held steady today after the company beat expectations on Wall Street with its second-quarter results. The Franklin Lakes, N.J.-based company swung to a net loss of -$50 million, or -19¢ per share, on sales of $4.22 billion for the 3 months ended March 31, up 42% compared with the same period […]
Veryan’s helical stent meets safety, efficacy endpoints after 12 months
Veryan‘s helical BioMimics 3D stent met its primary safety and efficacy endpoints in a study of 271 patients with symptomatic femoropopliteal artery disease, according to TCTMD. The device, which is shaped to mimic the natural geometry of human vasculature, compared favorably with drug-coated balloons and stents. The probability of maintaining primary patency after 12 months was […]
VIVA 17 Round-up: Medtronic touts real-world data for In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) touted data for its In.Pact Admiral drug-coated balloon this week at the Vascular Interventional Advances (VIVA) 2017 conference. The company presented two-year, real-world data from the In.Pact Global study, as well as four-year results from the pivotal In.Pact SFA study. Data from the In.Pact Global study showed a 83.3% rate of freedom from clinically-driven target […]
Bard lands new indication for its drug-coated balloon
C. R. Bard(NYSE:BCR) said today that its Lutonix 035 drug-coated balloon PTA catheter won premarket approval from the FDA and is available in the U.S. The company’s Lutonix 035 device is the first drug-coated balloon approved in end-stage renal disease patients with stenotic lesions in dialysis arteriovenous fistulae. Bard’s DCB is also approved to treat […]
QT Vascular launches pivotal trial for drug-coated peripheral balloon
QT Vascular said today that it launched the U.S. pivotal trial for its Chocolate Touch drug-coated peripheral balloon in the hopes of winning FDA approval. The device won CE Mark clearance in September 2015. The trial is slated to compare the safety and effectiveness of the Chocolate Touch balloon with Bard‘s(NYSE:BCR) Lutonix drug-coated balloon catheter. […]
Becton Dickinson to acquire Bard in $24B deal
Becton Dickinson (NYSE:BDX) has inked an agreement with C. R. Bard (NYSE:BCR) to acquire the medtech company for $317.00 per Bard common share in cash and stock, valuing the deal at $24 billion. In announcing the deal yesterday, Franklin Lakes, N.J.-based BD said it plans to create a new segment within the company, BD Interventional, to […]
Intact Vascular finishes patient enrollment for angioplasty clinical trial
Intact Vascular said today that it finished enrollment for the Toba II clinical trial evaluating its Tack Endovascular System in combination with standard or drug coated balloon angioplasty in arteries above the knee. The company’s trial enrolled 210 patients and will focus on the superficial femoral artery and the proximal segment of the popliteal artery, […]
Sanofi gains on Q4 results; a look at some of the top drug-delivery earners in 2016
Shares in Sanofi (NYSE:SNY) have gained 11% to $44.58 apiece since the company released its 4th-quarter and full year 2016 financial results in February. The French company posted profits of $731.5 million on sales of $8.21 billion for the 3 months ended Dec. 31, for bottom-line growth of 136.5% on sales growth of 3.3% compared with […]
Pharma stocks fall on Trump’s proposal to cut NIH budget
The Trump budget plan to slash more than 18% from the budget for the National Institutes of Health sent pharmaceutical stocks down today on Wall Street as investors reacted to the proposal. The budget proposal, released today, would cut the NIH budget by $5.8 billion, to $25.9 billion – an 18.3% cut. The proposal would also introduce […]
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