NeuroVoices: Joe Burnett, on FDA Clearance of SmartFrame OR Stereotactic System

Joe Burnett

ClearPoint Neuro

As neurosurgery continues to grow, the technology to improve these procedures, including in the pre- and post-operative stages, has expanded with it. More recently, the FDA granted 510(k) clearance to ClearPoint Neuro for its SmartFrame OR Stereotactic System, a device used to facilitate optimal preoperative placement of instruments and devices for neurological procedures.

Comprised of the SmartFrame OR and the ClearPointer Optical Navigation Wand, the SmartFrame OR Stereotactic System can enhance preoperative planning for electrode introduction, catheter placement, and brain biopsy procedures. The ClearPointer is intended to be used in conjunction with the SmartFrame OR and a compatible stereotactic optical navigation system for patient registration and navigation. Upon its original announcement, ClearPoint noted that it plans to commence limited market release in the first half of 2024, with a planned full market release in the second half of 2024.

As part of a new iteration of NeuroVoices, Joe Burnett, president and chief executive officer at ClearPoint Neuro, sat down to discuss the approval and what the SmartFrame system brings to neurology care. He spoke on how it can ease the workflow for neurosurgeons, the feasibility behind the product, and the patients who may be best suited for its use. In addition, he stressed the importance of how this device does not require the use of MRI during the procedure and how that contributes to greater access and compatability.

NeurologyLive®: How does this FDA clearance add to neurosurgical care?

Joe Burnett: When I joined the company about six years ago, at this point, the company had a different name. We were called MRI Interventions at the time, and our product portfolio was limited to only procedures that could be performed inside of the MRI. I met with our team, we talked about our strategy for the future, and we made the decision that that was no longer going to be the case for us to be stuck only in the MRI. Even though it's absolutely crucial for some particular types of procedures and patient presentations, that wasn't going to be the future of the company. We changed the name of the company to ClearPoint, and we decided to say, “hey, we're going to make products that are not only destined for the MRI, but other surgical arenas as well.” The significance of the SmartFrame OR, which stands for operating room, is that it'll be the first product that you don't need an MRI to still have the ClearPoint experience. And I think that's a very big deal for us.

In what ways does this improve the efficiency of operating room systems?

For us, it's the location that most of these procedures are happening today. There's somewhere between 20,000 and 25,000 stereotactic procedures that are done in the United States each year. A small fraction of these, less than 5%, are done in the MRI using ClearPoint. This gives us a chance to take everything we've learned from stereotactic navigation using live MRI and bring that learning into the operating room where now instead of having an MRI live as the input, we have a CT live as the intimate input, for example. About 7000 procedures of learning that have gone into our design and into our software, we now get to deploy that where 95% of these procedures are taking place. It doesn't force us as a company to say, you need to relearn everything and do it in the MRI. We can say, we just have a better device, a faster device that we'll be able to use with you in the familiar environment to you where you don't have to start from scratch.

Is this something that’s feasible for any neurosurgeon or does it require training and experience?

This should be the easiest product for us to bring into a lab because it doesn't require any of our hardware or software or capital equipment to come in. It's compatible with a device or a series of devices that are already very commonplace in the operating room today. One of our barriers that we've had historically is we'll walk in with new computer, new software, and you not only have to have the budget to get that in, but you have to get approval from it, you have to get a static IP address, you have to get through legal BA (business associate) agreements, all these types of things. With this, we're already working with equipment that's in the lab. There's no fear of cybersecurity issues because we're not introducing any new hardware or software. With that speed, I think it'll be much faster than anything we've done.

As far as getting up to speed and using the technology, that's kind of one of the beauties of working with ClearPoint. We provide a clinical specialist that comes and assists during the procedure to help with training to answer questions. Eventually, we think this product is easy enough that we wouldn't have to be there for every procedure, but for the foreseeable future, we plan on having an employee there to answer questions and deal with troubleshooting along the way. There's no such thing as a routine neurosurgery. We want to make sure we're there from a quality standpoint, and that we learn from the procedures on how to improve the product and in the years ahead as well. But it should be very fast ramp up with this type of technology.

Are there specific patients you see benefitting from this more than others?

It's interesting there's a lot of studies that have shown that many of the neurosurgery that is taking place, for example, deep brain stimulation implantation to treat Parkinson disease or epilepsy, there's a few different ways to go about doing that. One of the primary differences with some of the approaches is, are you able to put the patient asleep for that two to four-hour procedure? Or does the patient have to be awake for that procedure to utilize some other recording equipment to ensure the leads are the right place? What's interesting about this product is that I believe this will enable more patients to have access to surgeons that want to do the procedure asleep, whether it's a particular anatomy or because this extra recording doesn't do anything for that specific indication, or because it allows the patient to stay on their medication, as opposed to having to go off meds before the surgery, which can be pretty brutal for those 24 hours beforehand. Or even just patients that are afraid or scared or claustrophobic and would rather be comfortably under general anesthesia, as opposed to being awake for some of these procedures. This is another tool that facilitates a conversation with a patient and a surgeon to decide, "hey, which one of these approaches and technologies is the best way for me?"

Are there any thoughts on expanding the capabilities and functions the SmartFrame system provides?

Most of the exciting things that we work on in neuro are some of the technologies that are not available yet. At ClearPoint, we've got partnerships with more than 50 different pharma companies and biotech companies looking at cell and gene therapy delivery. None of these technologies are approved or available to patients yet, they're all in preclinical or clinical trials. If these trials are positive, these tools will be able to help actually cure some of these underlying diseases, and not just mask symptoms, which is what many of the common treatments are available today. The world of neurosurgery is really just getting started. There's a million patients with Parkinson disease and yet only about 9000 are treated each year. It's a very underserved patient population. I think if we can be sort of that common thread or platform that treats all of these different exciting new indications, that's the role and the responsibility we're willing to take on.

Is there anything else you’d like to mention on the approval?

We at ClearPoint always hung our hat on saying, "we've got the most precise navigation possible that can take place in the MRI, and you'll be able to see exactly where you are, and what your trajectory is before inserting anything into the patient." You get to decide guide and confirm each step along the way. But as I mentioned earlier, doing that meant you have to train anesthesia to work in the MRI suite. You pretty much have to go to a surgeon and say, “Hey, everything you've been doing for the last 15 years, we're going to tear it all down and build it back up.” Physicians don't necessarily have the time or the patience to learn something new. They're constantly inundated with a waiting list of patients that could be treated. Finally, we have a product where we can come in with something that's fast, easy, and fits into your workflow. If we can actually speed up some of these procedures and still deliver that same level of accuracy, it allows these patients that are waiting 2, 3, 6 months in the waiting line for the surgery to possibly get treated sooner. If you can pause those symptoms four or five months earlier, that can be really meaningful from a quality-of-life standpoint. That's really our focus with this technology.

Transcript edited for clarity. Click here for more iterations of NeuroVoices.