When it comes true innovation and you look at all of the greatest innovators of all time, they always picked up where others left off. The ones that have created the greatest value figured out where other devices were failing and they created the solution. In this case, all of the devices tackling artery blockages required a guidewire to aid them in navigating the vessel in order to clear a blockage. If the guidewire couldn't penetrate the lesion, they couldn't cross. They would have to figure out ways around it if it was even possible, -- even if it caused trauma to the vessel leading to bailout stenting. The next best option was invasive, costly bypass surgery and ultimately amputation.

More than 200,000 people have their legs amputated every year because of this problem.

That's where the market begins. That's why Ra Medical's entire DABRA FDA study focused on those patients where other devices failed.

Why create something and prove it can just do what every other device does?

True innovation goes above and beyond that.

That's the benefit of this device. It's a device designed to cross Chronic Total Occlusions (CTOs) without the aid of a guidewire. The challenge was that doctors aren't used to it. In fact doctors are trained in school and during the residencies that the guidewire is their go-to device to navigate the vessels. Funny thing, is that not only do guidewires get them into trouble more often than not by entering into subintimal territory and guiding atherectomy devices with them, but also doctors for many years were able to actually navigate the human vasculature without the aid of the guidewire. The guidewire was developed mainly to overcome the tortuosity of the coronary region.

Even still, I've heard many naysayers over and over again that say it can't be done, or that it needed to be changed to be like the other devices.

It doesn't make sense to me that a doctor wouldn't at least try a device that could navigate the vessel using basic wire technique they already know and that is safer for patients.

Most will try it. And I've learned is that if they're properly trained and they see proof of smooth, non-turbalent flow in the final run-off with their own eyes, they quickly become believers.

Doctors I spoke with candidly expressed their skepticism they had prior to use and how they now view what seemed to be a disadvantage, or impossible, is actually to DABRA's advantage as well as to patients who couldn't be treated otherwise by minimally invasive means. The key is - seeing is believing....

"Are you still unsure doctor? Check out a few more with a guidewire."

The cases below show the DABRA Catheter navigating the vessel alongside a guidewire without disrupting it. The guidewire is NOT aiding the DABRA Catheter in navigation, rather it's maintaining real estate already gained by DABRA in a previous pass through the vessel so the DABRA Catheter can increase lumenal gain.

The doctors would all say,

"Wow, if it can do what I see it does, then I'll try it. But there's no use in doing the cases I already can do with other devices."

Makes sense, right?

Well, it's definitely a tall order to expect that of any device.... to tackle the toughest patients.

Typically during a training you would think a doctor would want to start with the easier patients and ease up to the tougher cases.

But these doctors don't have the time or the money to waste.

Either the device works and is easy-to-learn/easy-to-use or they can't be bothered.

Obviously if the doctors are going straight for the impossible, there's an unmet need. Each one had cases in which they were at a loss at what other option they had other then to send the patient into invasive bypass or amputation.

Every doctor we visited from El Centro, California to Utrecht, Netherlands literally brought back patients in which other devices had failed and the DABRA would be their only hope to prevent bypass or amputation. Many of the patients were too sick for bypass. So, amputation would be the next step if DABRA didn't restore blood flow.

But DABRA was up for any challenge. In its FDA study, for DABRA to have successfully tackled only the toughest cases where other devices had failed with a 94% success rate with very little time for training, I had no doubt it would find the same success with doctors and their toughest cases beyond FDA clearance.

The inventor Dean Irwin could quickly get a doctor up-to-speed and and assist them in success after success in the toughest cases in which other devices continued to fail.

Doctors told me they prefer to clear blockages in the least invasive, least traumatic way possible. Not one doctor I spoke with ever wanted to sentence a person to amputation. Knowing DABRA would give them one last shot limb salvage, they were quick to want to try the device. Some barely even wanting to sit through training. They wanted to get right in the cath lab, scrub in, and put DABRA to use.

Why would they want to go through extensive training if the device didn't work?

You might wonder how it's possible for these doctors to use this device for the first time without much training. Engineers designed the DABRA Catheter to easily navigate through the twists and turns of the human vasculature. It was just a matter of the doctor getting used to a few nuances -- one being they don't have to work as hard. These physicians are accustomed to pushing and forcing vessels open with whatever was at their disposal. I saw them be very creative in trying to help their patients - even flipping guidewires around and using their sharp distal end to poke through tough, calcified lesions.

Their dedication was clear, but from my observation and discussions with them, obviously they needed a new tool, one that was less traumatic and more effective.

The trick to the success in using DABRA, was they needed to ease up, NOT push, and let the DABRA's photoablative properties do the work.

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I've watched the inventor train doctors and offer step-by-step guidance and support through a procedure to clear blockages other devices couldn't and the proof is in the final run-off.

First time out of the gate...what I saw was remarkable - success after success!

The number of first-case success stories blew my mind.