Blog Tag: Clinical Trial
The FDA has announced new goals to help modernize its procedures and respond to new technologies. In a blog post by FDA Commissioner Scott Gottlieb, M.D., the agency expressed new priorities to help modernize clinical trials for medical devices and develop standards for new technologies like artificial intelligence.
According to Gottlieb, clinical trials “are becoming more costly and complex to administer” while “new technologies and sources of data and analysis make better approaches possible.” In order to take advantage of these better approaches, Gottlieb pointed to the FDA’s Breakthrough Devices Draft Guidance, which proposes streamlined procedures to develop flexible clinical trial designs for important medical devices. This will allow the FDA to “evaluate . . . innovative devices more efficiently.” Six breakthrough devices have already been cleared using this program.
Additionally, Gottlieb discussed the FDA’s new goal of enabling the use of “real-world evidence” to support decisions to approve devices. According to Gottlieb, “[r]eal world evidence can help answer questions that are relevant to broader patient populations or treatment settings where information may not be captured through traditional clinical trials.” The FDA is helping to design several proof-of-concept trials that utilize real-world evidence.
Finally, Gottlieb discussed the FDA’s role in dealing with new and emerging technologies. In particular, Gottlieb discussed artificial intelligence, which “holds enormous promise for the future of medicine.” Medical artificial intelligence models are currently in development and the FDA recently approved an AI algorithm for detection and treatment of distal radius fractures. According to Gottlieb, the FDA is exploring ways to handle and evaluate the kinds of data that are relevant to AI performance and safety, hoping to “enable a transparent benchmarking system for AI algorithm’s performance.”
Gottlieb concludes that the FDA has “undertaken a comprehensive effort to make sure that our organization and policies are as modern as the technologies we’re being asked to evaluate, and that we’re able to efficiently advance safe, effective new innovations.”
Medtronic recently announced continued success with what it describes as “the world’s smallest pacemaker.” The Micra® Transcatheter Pacing System (TPS) is less than one-tenth of the size of traditional pacemakers (examples of each type of pacemaker, both produced by Medtronic, are shown to the left). Medtronic states that the device provides select patients suffering from bradycardia with a minimally invasive treatment approach.
The Micra TPS, which is comparable in size to a large vitamin (as seen to the right), attaches to the heart with small tines and delivers electrical impulses that pace the heart. Thanks to its size and wireless technology, the Micra TPS does not require
leads under the patient’s skin. As such, the Micra TPS eliminates potential sources of complications that may be associated with more traditional pacemakers. Artist’s renderings comparing the Micra TPS and a traditional pacemaker when implanted are shown below.
Following what Medtronic describes as “the largest and longest clinical evaluation of leadless pacing patients to date,” the company released several statistics from its Micra TPS Global Clinical Trial that highlight the device’s long-term successes, including:
- 96% freedom-from-complication rate
- When compared to traditional pacemaker systems, the risk of
- major complications was reduced by 48% across all patient subgroups including age, gender and comorbidity
- hospitalization was lowered by 47%, and
- revision procedures was 82% lower
- The battery is projected to last an average of 12 years, based on data from 644 patients who have had the device for at least 12 months.
Regarding these results, John Liddicoat, M.D., senior vice president at Medtronic, stated:
The Micra TPS continues to deliver safe and effective pacing, while also providing a less invasive alternative to conventional pacemakers . . . . The Micra TPS has also shown a significant reduction in healthcare utilization compared to conventional pacemakers, which is promising for clinicians looking to adopt cost-effective therapies to improve patient outcomes.
These statistics follow preliminary results published in the New England Journal of Medicine in November 2015, showing that the Micra TPS was successfully implanted in 99.2% of patients. Medtronic interprets the studies as demonstrating consistent and sustained results from early performance through 12-month follow-up.
Dr. John Hummel, a cardiologist who participated in the clinical trials, explains his view that Medtronic’s wireless pacing technology is the future of pacemaker therapy.
We are looking at the beginning of the future . . . . We will no longer pace the heart in the way we have in the last 20 to 30 years. This is fundamentally a paradigm shift in how we’ll deliver this therapy.
The Micra TPS was awarded its CE Mark in April 2015. Additionally, the device was approved by the FDA for use in the United States in April 2016. The device is presently the only leadless pacemaker approved for use in both the United States and Europe.
Second Sight announced in a press release the publication of positive results from a long-term clinical trial of the Argus II Retinal Prosthesis System. According to the press release, the five-year trial included 30 subjects who were blind due to retinitis pigmentosa (RP). The results, which will be published in Ophthalmology, indicate that the Argus II device provided improved visual function that was sustained over the course of the trial. The study further reported improved patient well-being and an acceptable safety profile. Will McGuire, President and CEO of Second Sight, said:
“We are excited to see that the substantial visual improvement gained from the Argus II endures over five years – promising news for patients blinded by RP, as well as for our company’s continued efforts to restore vision.”
The Argus II Retinal Prosthesis System assists wearers with RP-related blindness by capturing images using an eyeglass-mounted camera, converting the images to electrical pulses, and transmitting the electrical pulses to the retinal surface. The Argus II system received FDA approval in February 2013, and according to the press release a 2014 study supported the device’s long-term cost effectiveness.