Cerus (NSDQ:CERS) landed a $15 million amendment to its contract with the U.S. Dept. of Health & Human Services’ Biomedical Advanced Research and Development Authority, bringing the total potential value of its deal to $201 million. The expanded agreement is designed to support additional clinical trials of the company’s Intercept blood transfusion technology. Cerus’ Phase III […]
Boston Scientific’s drug-coated balloon succeeds in femoropopliteal segment at one year
Data from Boston Scientific‘s (NYSE:BSX) Ranger SFA trial showed that treatment with its drug-coated balloon succeeded in the femoropopliteal segment after one year and resulted in greater rates of patency, with fewer interventions, compared to standard balloon angioplasty. The results, which were published this month in JACC: Cardiovascular Interventions, demonstrated that both groups of patients – […]
Medtech stories we missed this week: May 11, 2018
From ReShape submitting an approval application to Health Canada to Conavi receiving FDA clearance, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. ReShape submits for Health Canada approval of ReShape balloon ReShape announced in a May 10 press release that it has submitted an application to the Medical Devices Bureau of […]
HRS 2018: Study questions benefit of ablation over drug therapy for atrial fibrillation
Long-awaited data released today from a large clinical trial comparing catheter ablation with drug therapy in treating atrial fibrillation showed no significant benefit for ablation, according to Dr. Douglas Packer, who presented the findings today at the annual meeting of the Heart Rhythm Society in Boston. The 2,204-patient trial, sponsored by the National Institutes of […]
For this Abbott executive, solving problems isn’t enough: ‘We need to add value’
As payers and providers across healthcare shift their focus to value-based care, leaders in the medical device industry are racing to keep up. Michael Pederson, SVP of cardiac arrhythmias and heart failure at Abbott, told MassDevice.com why simply solving problems with new technology isn’t enough anymore. What was your path like from electrical engineering to […]
Abbott’s Xience Sierra drug-eluting coronary stent wins reimbursement in Japan
Abbott (NYSE:ABT) said today that it won national reimbursement in Japan for its everolimus-eluting stent, Xience Sierra, which is designed to treat patients with coronary artery disease. The company’s latest drug-eluting device features a thinner profile, increased flexibility and longer lengths than previous stents, according to Abbott. The healthcare firm said it developed Xience Sierra to […]
Regeneron, Sanofi strike pricing deal with Express Scripts for cholesterol drug
Regeneron Pharmaceuticals (NSDQ:REGN) and its partner, Sanofi (NYSE:SNY), have agreed to lower the cost for its cholesterol drug, Praluent, for Express Scripts (NSDQ:ESRX) in exchange for an exclusive spot on the pharmacy benefit manager’s national formulary. The agreement, effective July 1, is designed to broaden patient access to the injectable medicine and lower out-of-pocket costs for eligible […]
How CHF Solutions is using health economics to expand product adoption
Two years after CHF Solutions (NSDQ:CHFS) acquired Baxter‘s (NYSE:BAX) Aquadex fluid filtration device for $5 million, the company’s executives are working to weave together the evidence they need to land reimbursement in the U.S. and expand patient access for its technology. The Aquadex system is designed to filter water and salt from patients experiencing fluid overload due […]
Companies push back against allegations of FCA violations over excess at-home blood testing
A 70-year-old former Marine is taking a group of companies to court over their at-home blood testing services, arguing that the industry players broke the law by requiring patients to conduct weekly tests. The companies then submit these bills to Medicare for reimbursement, even asking to be repaid for services that weren’t rendered, according to […]
FDA approves label update to Novo Nordisk’s Tresiba diabetes drug
The FDA approved Novo Nordisk‘s (NYSE:NVO) request to include heart health data on the label of its Tresiba insulin degludec product. The Danish insulin-maker evaluated its Type II diabetes drug in a 7,637-patient trial, assessing the therapy for cardiovascular safety compared to insulin glargine. Novo Nordisk’s Devote trial met its primary endpoint after Tresiba demonstrated […]
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