Boston Scientific enrolls first patient in blood thinners/stents trial

January 4, 2010 By MassDevice staff

Boston Scientific Corp. (NYSE:BSX) enrolled its first patient in a worldwide trial examining the use of blood thinners in conjunction with drug-eluting stents, joining a trio of other industry giants and their pharmaceutical partners in the study.

Participating in the four-year DAPT Study are Natick, Mass.-based Boston Scientific, manufacturer of the Taxus and Promus stents, along with device makers Medtronic Inc. (NYSE:MDT), Abbott Laboratories (NYSE:ABT) and Cordis Corp., the stents arm of healthcare conglomerate Johnson & Johnson (NYSE:JNJ). Drug-makers Bristol-Myers Squibb Co. (NYSE:BMY), Sanofi Pharmaceuticals (NYSE:SNY), Eli Lilly & Co. (NYSE:LLY) and Daiichi-Sankyo Company Ltd. (TYO:4568) also have signed on for the study.

The Harvard Clinical Research Institute, an industry-supported facility based in Boston, enrolled the first of 20,000 individuals slated to participate in the trial in October, 2009. Boston Scientific said its participation will look at the Taxus Liberté stent, which elutes a drug called paclitaxel, and the use of aspirin and Effient, an anti-coagulant made by Eli Lilly and Daiichi Sankyo. The company said it plans to contribute data on the first 1,524 eligible patients from its post-approval study of the Taxus Liberté to the DAPT Study.

Current medical guidelines call for patients receiving drug-eluting stents to use blood thinners during the first year following their procedures to guard against the effects of possible artery lesions. Some doctors, however, continue to prescribe anti-platelet drugs after more than 12 months. The HCRI study hopes to determine if the extra medication significantly reduces the risk of stroke, heart attacks or other problems.

The double-blind trial is expected to enroll more than 15,000 subjects being treated with a drug-eluting stents at over 200 locations around the world, as well as 5,000 subjects treated with a bare metal stents. All patients will receive anti-platelet drugs during the first 12 months in addition to their daily aspirin regimen. After the first year, all of the patients who do not show signs of abnormal bleeding will be split into equal groups — half of whom will get a placebo and the other half receiving blood thinners during the next 18 months.

All patients also will continue to use small doses of aspirin every day and will be monitored during a three-month post-trial period.

“This study is the first post-market investigation in which the FDA brought together industry competitors who put aside competition and achieved an unprecedented level of cooperation with regulators and academia to answer a major public health question,” said Margaret A. Hamburg, commissioner of the U.S. Food and Drug Administration.

FDA opens umbrella authorization for surgical masks
Faced with a growing number of coronavirus cases and a shortage of personal protective equipment (PPE), the FDA has extended emergency use authorizations (EUAs) to certain surgical masks that are not protective against small airborne particles. Unlike N95 and some KN95 respirators, these masks “may be effective in blocking splashes and large particle droplets,” the… […]
Medtech and COVID-19: 7 things you need to know
When COVID-19 set upon the U.S. in March, medtech executives only had a month at most to explain to analysts in quarterly calls how the pandemic was hitting their companies — not nearly enough time to understand the long-term impact. Three more months have passed since those quarterly calls, and we’re now wrapping up a… […]
Report: Will Dr. Hahn crack under political pressure?
Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of defending science while working for the Trump administration, according to a New York Times report. Hahn… […]
Hologic spending more than $50M to expand COVID-19 test production
Hologic (NSDQ:HOLX) is spending $50 million — including $14 million during its most recent quarter — to boost its production of COVID-19 tests. The U.S. government is providing $7.6 million to support the effort. Hologic’s business partner Stratec is also doubling the production of the Panther instruments that run Hologic assays. Get the full story on our sister site… […]
DTW Podcast: 10 ways medtech is finding its footing amid COVID-19
When COVID-19 set upon the U.S. in March, medtech executives had a month at most to tell Wall Street analysts how the pandemic had hit the industry’s largest companies. We heard about short-term hits in revenues, procedures and employee headcounts, but uncertainty clearly ruled the day. Over the past few weeks, medtech executives from several… […]
3M lays off another 1,700 workers, many related to former drug delivery business
3M (NYSE:MMM) laid off another 1,700 workers during its second-quarter — with many of the jobs related to the company’s divested drug delivery business. The layoff — announced as part of an SEC filing on July 28 — comes after the Maplewood, Minn.–based manufacturing conglomerate said early this year that it would lay off 1,500 workers — though… […]
Millstone Medical completes headquarters expansion
Millstone Medical Outsourcing has completed its previously announced headquarters expansion in Fall River, Mass. The expansion includes 60,000 square feet of state-of-the-art warehouse and office space that expands capacity in Fall River to 120,000 square feet of production space. The expansion includes 4,500 square feet of mechanical inspection, 31,000 square feet of warehouse area, and… […]
Confluent Medical opens catheter development center in Austin, Texas
Confluent Medical this week announced it has opened a Complex Catheter Design and Development Center in Austin, Texas. The facility is a rapid-prototyping, development and pilot facility that expands the company’s ability to provide customers with electrophysiology and neuromuscular catheters and complex delivery systems for structural heart and vascular applications. Confluent Medical also said its […]
J&J’s Ethicon touts surgical stapler study
Ethicon — part of Johnson & Johnson (NYSE:JNJ) — is highlighting new study results in which its Echelon powered stapler with gripping surface technology (GST) had a lower rate of bleeding-related complications than a competing Medtronic product. Ethicon funded the peer-reviewed study, which appears online in Medical Devices: Evidence and Research. The study compared the Echelon… […]
Instron to hold virtual biomedical testing open house
Instron (Norwood, Mass.) plans to hold its first-ever virtual Biomedical Testing Open House, August 24–27. Register on Instron’s website. The online event will bring together materials testing experts for a mix of presentations and Q&A sessions. Topics will include PPE and medical device testing, understanding regulatory standards, ensuring data integrity and traceability, and more. Experts… […]
Nolato Group acquires GW Plastics
GW Plastics (Bethel, Vt.) announced today that the Nolato Group (Torekov, Sweden) has acquired it. Financial terms of the deal were not disclosed. GW Plastics’ seven global manufacturing facilities will join Nolato’s more than 25 facilities worldwide — creating a solid position for the newly merged company in North America, Asia and Europe. Officials at… […]