Do you think DABRA will enable you and others to do cases that otherwise might not be able to be done as effectively initially?
What was most interesting to me about Ra Medical System's FDA study for the DABRA Laser System, was that they designed it for only those patients who didn't have other options. Basically, only the cases in which a CTO couldn't be crossed with a guidewire. All but one other device on the market requires a guidewire in order to create a channel through a blockage.
It was surprising to me that they would choose to only tackle those CTO's that couldn't be crossed with a guidewire because a 510(k) is about proving equivalency to a product already on the market. They could've taken the path of least resistance as the other laser can't cross without tracking a guidewire.
The CEO Dean Irwin told me, "We did this because we set out to design a device that we hoped would not just improve patient outcomes compared to other similar devices, but to do what no one else has been able to do, and treat those patients who were on the verge of amputation."
And it turns out that he was right in taking this approach, because as UCSD's Chief of Cardiovascular Medicine explains below, that in order to truly have an impact on this market, you need to address those cases in which "there's nothing else we can do."
In many cases I witnessed over the course of not only the FDA study, but around the world, there were actually vascular surgeons on standby to amputate in case the DABRA Laser System didn't work.
Ehtisham Mahmud, MD
UCSD's Chief of Cardiovascular Medicine
Never a shareholder. Never any financial interest. Never a consultant. FDA Study Principal Investigator.
This case is the perfect example of the DABRA advantage
Aside from all of the cases Dr. Athar Ansari performed during his participation in the FDA study for DABRA, in which other devices had failed and amputation would be the next option, Dr. Ansari continues to get patients who didn't receive satisfactory treatment at other facilities with different devices. This 64-year-old woman was referred to Dr. Ansari by an ER doctor at El Centro Regional Hospital who was treating her following a heart attack. Her primary Cardiologist was at a large University hospital. She said her doctor never told her she was at-risk for a heart attack. They were primarily treating her for Peripheral Artery Disease. Even more, she had multiple atherectomy procedures performed by doctors at the University hospital, that were not successful. They told her she would have to come back regularly to have her arteries re-opened. Dr. Ansari used the DABRA Laser to open up blocked arteries in both legs. Five months later she remains patent and pain-free.
Never a shareholder. Never any financial interest. Never a consultant. FDA Study Participant.
When amputation is almost imminent?
3 Doctors Share Cases that were unsuccessful at other facilities.
Disclosure: None of these doctors are shareholders. None of these doctors have any financial interest. None of these doctors have ever been a consultant.
Mattijs De Vries, MD
This case is also featured in the above montage. But in case you didn't watch, here's Dr. De Vries explaining how he was able to use DABRA to save one leg of a woman who had continued restenosis in both legs, causing one leg to have already been amputated.
Disclosure: Never a shareholder. Never any financial interest. Never a consultant.
"This is a patient that self-referred...," explains Mitul Patel, MD.
Mitul Patel, MD
UCSD Health System
Never a shareholder. Never any financial interest. Never a consultant.
In-stent? Thrombus? Restenosis?
Dr. Athar Ansari invited Dean Irwin, CEO of Ra Medical Systems, and I to observe his 110th case this summer. I was hesitant to accept the invitation only because I'd observed many SFA cases before and captured some of the toughest cases on camera during Ra Medical's FDA study. But it happened to be National Nurses Week and I wanted an interview about the critical role of nurses in outpatient facilities versus tertiary centers.
I was glad I went and I was even happier that I had the camera rolling in the Cath Lab when Dr. Ansari tackled a CTO at the ostium of the right SFA of an 82-year-old man who has had multiple procedures, including stenting, with continued restenosis.
The blockage was thrombus, which is scary because if it dislodges, it could potentially cause a fatal complication called an embolism. So, I've learned that doctors must tackle that carefully with as little irritation as possible. The DABRA glided right through with no problem.
Afterwards, I asked Dr. Ansari to comment on the case. To which he told me that this is the go-to device for these types of cases due to its 'unique properties.'
Athar Ansari, MD
California Heart & Vascular Clinic
El Centro, California
Disclosures: Never a shareholder. Never any financial interest. Never a consultant.