This is an INDEPENDENT website developed by long-time Emmy Award-winning Journalist Kym McNicholas.

 

This site is NOT in any way associated or affiliated with Ra Medical Systems or its DABRA Laser System

 

It depicts my journey following what I believe is a breakthrough medical device from FDA Clearance to commercialization to IPO...and beyond.

One day during the FDA Study there was a case in which the blockage didn't fit within the criteria for the study. It was a CTO that COULD be crossed with a guidewire. Coincidentally, a rep from the competing laser company happened to be at the Cath Lab that day. She encouraged Dr. Athar Ansari to use her product.

He did. And she was so confident in her product, she allowed me to remain in the Cath Lab with my camera rolling.

The use of the competing laser resulted in the first adverse event I had witnessed since starting on this journey. And it was NOT with the DABRA.

In the video below, you'll hear Dr. Ansari not only explaining the difference between the two lasers, but also his candid commentary during the use of the competing laser in the procedure itself, as well as the patient's reaction as it was attempting to clear the blockage.

At every conference we attended, doctors would approach Ra Medical's booth skeptical of Ra Medical's claims that the DABRA Laser System could actually stay within the true lumen without the aid of a guidewire.

Doctors are trained to use a guidewire. There's only one other device on the market that works without a guidewire, and it's simply a crosser. But in my 20 years covering innovation, the biggest technological breakthroughs are those that make the impossible, possible. Each doctor agreed that if it could do what it claims, the DABRA Laser System would be revolutionary. Often times these guidewires lead the treatment to an undesirable path, withing the structure of the artery instead of inside it. This is known as subintimal, and often requires a stent to prop the vessel open.

So, after trying the DABRA Catheter, each and every doctor who expressed skepticism to me, was quick to tell me ON CAMERA about their success using the device. In fact, Dr. Athar Ansari has performed about 150 procedures using the DABRA Laser System, and he tells me every doctor should have it in their armamentarium.

What Do The Longer Term Results Look Like With The DABRA Laser System vs. Other Technologies?

No stents and low inflation rates?

My very first interview for "The Innovators Network" was with Dr. Ernesto Rodriguera. The first in-human DABRA Laser System case was performed in his Cath Lab with UCSD's Dr. Ehtisham Mahmud. He has since performed more than 27 cases. And what was most surprising to me was hearing that in the five years since the first case was performed, every single patient remained patent.

Even more surprising to me was they remained open WITHOUT stents. Stents were revolutionary when it comes to coronary procedures. But what I've learned is that they're not optimal for use in the legs due to the risk of getting crushed with daily mobility. Plus, it's a foreign object placed in the body that could potentially increase trauma to the vessel.

The goal is to open the vessels with the least amount of trauma. That's why the final surprise was hearing about low balloon inflation rates following the DABRA Laser procedure. Typically the devices create a channel and loosen the plaque. And the best outcomes they say are those in which the balloon can push the plaque further to the sides of the vessel with the least amount of pressure possible to reduce trauma. And doctors were able to cut the inflation rate by half in some cases after using the DABRA Laser System.

Below, doctors I spoke with share their long-term results:

I first met Sandra Lopez at the California Heart & Vascular Clinic in El Centro, California in 2016. She was the scrub tech for Dr. Athar Ansari, who was a participant in Ra Medical's FDA study. Her reception was not a warm and welcoming one. She was very nice. But she kept us at arms length, with every interaction short and procedural. It was obvious she was skeptical of the technology.

Why wouldn't she be skeptical? She had sales reps visiting her daily promoting their products, making big claims that don't always play out, and ultimately creating more work for her at a time when she was already wearing multiple hats.

So, what would make Ra Medical any different? It was simple: Do they have a product that would improve her patient outcomes, make her job easier, and decrease her exposure to radiation on a daily basis? Time would tell.

By the third visit her entire demeanor changed towards us. She was not only warm and welcoming, but was forthcoming about all of the cases she was excited to see the laser used for that day.

When I asked Sandra what had changed, she said, "Dr. Ansari is not the type of person who would fall for anything, and so seeing him excited about the technology, seeing the patient outcomes, and the fact it made my job easier, really made a believer out of me."

Sandra told me that the catalyst for her deciding to leave her job as the right hand for Dr. Ansari in the Cath Lab and join Ra Medical as a Clinical Specialist was " ...not only did it work, but it was safer, quicker, and the results with patients was great."