St. Jude Medical (NYSE:STJ), which paused implantations of its Portico replacement heart valve last fall out of an abundance of caution, won the FDA’s approval to resume U.S. implants of the device in a clinical trial, the company said yesterday. Back in September 2014, St. Jude said CT scans turned up a potential problem with the Portico valves in […]
Clinical Trials
Positive early data for Valtech’s Cardioband
A trial of Valtech Cardio‘s Cardioband transcatheter annuloplasty system showed no device-related mortality, with decreases in mitral regurgitation and septo-lateral dimension. Results from the 40-patient multicenter observational study, designed to evaluate the safety and performance of the Cardioband, were presented this week at the European Society of Cardiology’s annual meeting in Paris. The study was […]
Creating a compliant, lock-tight site budget for clinical trials

By Kathi Shah, MS, MBA
Creating a clinical trial site budget sounds simple right? A Sponsor contracts with an investigative site to conduct a clinical trial per the protocol. The Investigative site is compensated by the Sponsor to conduct the services outlined in the protocol. The relationship between the Sponsor and Investigative site is heavily weighted on the budget developed to compensate sites for their efforts to conduct the study.
FDA guidance outlines principles for adaptive design in device clinical trials

By Stewart Eisenhart, Emergo Group
New draft guidance from the US Food and Drug Administration lays out appropriate uses of medical device clinical trial designs that allow for planned trial changes to be implemented based on accrued data while maintaining study validity and integrity.
Progress on clinical trials and demographic information | Regulatory news for the week of February 23, 2015
Recent progress on demographic information and clinical trials
By Barbara D. Buch, M.D.
At FDA, one of our foremost responsibilities is to evaluate and if medical products meets the appropriate standard, to approve or clear drugs, biological products and medical devices. We know that these products are safer and more effective for everyone when they are tested in clinical trials that include diverse populations.
A CDRH Priority: Clinical Trials in the U.S.

Owen Faris, Ph.D., Clinical Trials Director (acting), Office of Device Evaluation in FDA’s Center for Devices and Radiological Health
By Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D.
At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but that also present the greatest risk to patients.
Clinical trials: Enhancing data quality, encouraging participation and improving transparency
Indian regulators clarify requirements for medical device registrations, clinical trials

By Stewart Eisenhart, Emergo Group
New orders from the Indian Ministry of Health & Family Welfare’s Central Drugs Standard Control Organization (CDSCO) clarify some requirements regarding the country’s sometimes opaque medical device registration and clinical trial regulations.
Filling information gaps for women in medical device clinical trials

By David Strauss, M.D., Ph.D.
At FDA’s Center for Devices and Radiological Health (CDRH), results from clinical trials often serve as the foundation for our decisions to approve the most important medical devices—devices, such as implantable heart devices, that carry the greatest risk to patients and have the potential to save or sustain life.