Research In Brief

Test improves DES outcomes: Routine measurement of fractional flow reserve (FFR) - the ratio of maximal blood flow in a stenotic artery to normal maximal flow - with St. Jude's PressureWire Certus guidewire-mounted sensor improves outcomes of drug-eluting stent implants in patients with multivessel coronary artery disease, according to results of the FAME trial published in the Jan. 15 New England Journal of Medicine. The 20-center trial randomized 1,005 patients with multivessel disease to undergo implantation of drug-eluting stents guided by angiography and FFR or drug-eluting stent implantation guided by angiography alone. The overall composite adverse event rates were 18.3% in the angiography-alone group and 13.2% in the FFR group. Adverse events included death, non-fatal myocardial infarction and repeat revascularization. The trial also showed that including FFR in the procedure saved money and only added one minute to the average procedure time (71 minutes versus 70 minutes). The average procedure cost was $6,007 in the angiography-alone group compared to $5,332 for the FFR group, partly because FFR measurement led to the implant of fewer stents. The FFR group received an average of 1.9 stents per patient compared to 2.7 for the angiography-alone group, even though patients in the FFR group had an average of 2.8 coronary lesions compared to 2.7 for the angiography-alone group. The study was sponsored by Medtronic, Friends of the Heart Foundation and St. Jude Medical/Radi Medical Systems

More from Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 
• By 

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Shape Our Content: Take The Reader Survey

 
• By 

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, content format or the method in which you receive and access Medtech Insight, or if you love it how it is, now is the time to have your voice heard.

Patients With Movement Disorders Will Benefit From Medtronic’s Expanded MRI Labeling For DBS

 
• By 

Medtronic announced it received expanded MRI labeling for its DBS systems, which is critical, given that almost 70% of all DBS-eligible patients will likely need an MRI at some point in their care, says Ashwini Sharan, CMO for Medtronic Neuromodulation.

Podcast: Lung Life AI CEO Shares Regulatory And Reimbursement Journey For Lung Cancer Diagnostic

 

In this episode, Medtech Insight reporter Natasha Barrow speaks to LungLife AI CEO Paul Pagano. Lung Life AI is a US-based AIM-listed medical technology company that has developed a liquid biopsy test for the early detection of lung cancer called Lung LB. Pagano runs through the highlights of Lung Life AI journey to date and its future ambition for a strategic partnership. He also provides advice to similar diagnostic companies seeking reimbursement andcompliance with the US FDA Lab Developed Test ruling.

More from Medtech Insight

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By 

Congress has launched an inquiry into 23andMe amid privacy concerns following its bankruptcy, particularly regarding the potential sale of sensitive user data. Additionally, a Cybernews report gave 40 DNA testing firms an average cybersecurity grade of D, citing widespread vulnerabilities and data breaches, along with inadequate public information about their security practices.

Looking Back Towards The Future

 

As it celebrates 75 years shaping the medtech industry, Medtronic invited Medtech Insight to its Minneapolis headquarters to get a closer look at the company’s past, what it’s working on now, and what’s on the horizon.

Notified Bodies Warn Of Hurdles In The Way Of Their AI Designations

 

Will challenges in the way of designations of notified bodies that assess AI-enabled medical devices create delays and bottlenecks and slow EU medtech innovation?