Route 92 Medical (R92) is raising the bar and advancing the treatment of acute ischemic stroke through its 250-patient SUMMIT MAX clinical trial, the first randomized controlled trial to evaluate the safety and effectiveness of “super-bore” 0.088” aspiration catheters. The company recently announced enrollment is complete in SUMMIT MAX, which features the company’s Monopoint Reperfusion System, including the HiPoint 88 and HiPoint 70 Reperfusion Catheters and the Tenzing Catheters. HiPoint is currently approved by the FDA as an access catheter, but the company plans to submit the results of SUMMIT MAX to the FDA to obtain the NRY indication, which would allow physicians to use the device on label as an aspiration catheter.
For an update on R92, its products and what SUMMIT MAX means for the company and market, SmartTRAK interviewed Adam Hattan, R92’s vice president of marketing. Click on the video below to listen to the interview, recorded via Google Meet (19:48 min). A link to download the complete transcript of the interview is also provided below.
Anne Staylor here with SmartTRAK. Today I'm talking with Adam Hattan, Route 92 Medical's Vice President of Marketing. Adam, thanks for talking with me today.
Adam Hattan: Thank you for having me.
It's been a while since we talked, but this seems like a good time to catch up because you have some recent news about your SUMMIT MAX trial. Let's start by having you providing kind of an overview of SUMMIT MAX, where it's at, what the big news is and what it means for Route 92.
AH: Yes, thank you, Anne, I appreciate that. We've just finished enrollment in a 250-patient trial. It was a randomized, controlled trial comparing the Route 92 Medical HiPoint 88 catheter and Monopoint System to the next largest size catheter that was already cleared for aspiration thrombectomy by the FDA, the Vecta 74. And we finished enrollment in that trial, 250 patients at 30 centers. It's taken us about two years or so to enroll that number of patients in the trial and onwards and upwards.
What does that really mean for this area?
AH: Yes, that's a good question. I think what it means for the market is that ...
To download the complete transcript of the interview w/ Adam Hattan, VP of marketing for Route 92 Medical, conducted by Anne Staylor, SmartTRAK Executive Editor, VP & GM of Neuro Therapies, just click the button below.