Medtronic (MDT) announced FDA approval for the Inceptiv closed-loop rechargeable spinal cord stimulator (SCS), the second closed-loop SCS device to reach the market using evoked compound action potentials (ECAPS). The company previously launched Inceptiv in Europe and Japan and plans to initiate Inceptiv’s US market launch in the coming weeks.
SmartTRAK recently interviewed David Carr, MDT’s vice president and general manager of Pain Interventions, to learn more about Inceptiv, what differentiates it from other SCS devices and what it means for Medtronic and the SCS market. To listen to the interview, click on the following video (22:54 min). A link to download the complete transcript of the interview is also provided below.
Anne Staylor here with BiomedGPS. Today, I am talking with David Carr, who is the vice president and general manager of Pain Interventions at Medtronic. Exciting news, David. Medtronic now has FDA approval for your Inceptiv SCS device, an ECAPs-based device. So David, tell me what does Inceptiv mean for Medtronic?
David Carr: Good afternoon, Anne, and thank you for your time today and your interest in this announcement for us. This is a big moment for Medtronic and especially for the pain team within Medtronic. This is technology that has taken many, many years to develop. If you think back to the pivotal RCT, we did ECHOMAC, which demonstrated the performance of closed-loop technology, the algorithm, many years ago. Six published manuscripts across many recognized journals. Twenty peer-reviewed abstracts and posters, data from over 200 patients and several million ECAPs. So this is not something that's just been developed in the last couple of years. There's been a tremendous amount of work invested in this platform. So this is a very big moment for Medtronic, finally getting approval with the FDA to launch the product in the US market. Because as you know, we've already launched this product in Europe and Japan, and we're already seeing the tremendous patient benefits that the product brings to the market.
Let's start by having you talk about the technology itself. What are the key differentiators for Inceptiv versus other ECAPs-based devices on the market?
DC: Well, there's only one other ECAP-based product on the market, and that product is essentially closed-loop paresthesia. Okay, what differentiates this product is ...
To download and read the complete interview "Inceptiv SCS: Offering Options in a Closed-Loop Device" with David Carr, VP and GM of Pain Interventions at Medtronic, just click the button below.