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.

I gave a keynote at The Money Show in San Francisco in August of 2016 talking about the atherectomy (removal of plaque from arteries) market being ripe for innovation and investment at a time when an aging population is increasing and peripheral artery disease is becoming more prevalent. The timing is right with the shift to minimally invasive procedures as opposed to invasive bypasses, combined with a favorable reimbursement scenario for these procedures, which is driving the opening of numerous outpatient facilities across the U.S.

But it's more than that. Doctors are craving better, safer, faster, and more economical devices. Why? While the atherectomy market is flooded with options for doctors, including directional, orbital, photo-ablative (laser), and rotational devices, they still can't get through long, tough, calcified CTO's in the SFA if a guidewire can't cross. Longer term studies are showing these are not preventing restenosis (arteries becoming blocked again quickly). And I'm not surprised.

I've seen many of the devices in action while traveling across the U.S. and to countries throughout Europe, including a different laser that burned a patient during the procedure, a rotational device that took more than 4 minutes to set-up which left flaps in the vessel that were evident on IVUS, and another rotational device that chewed up a 94-year-old woman's vessel right before our eyes. And don't get me started on the numerous guidewire mishaps I've caught on video, which unfortunately doctors say is a daily practice, that more times than I can count, required bailout stenting.

It's not a secret. Adverse events caused by medical devices are public information on the FDA's website. That's why it's not a matter of if patients will be back for a repeat procedure, it's simply a matter of when. I think Dr. Ernesto Rodriguera says it best, "The reason new technologies are in development is that none of these technologies are capable to maintain the vessel open."

That is... until now. During my interview with Dr. Rodriguera, he added that, because of the unique properties of the DABRA Laser System, with it's solid-fill tip designed to track the true lumen, delivering 100% photoablative properties, it could "revolutionize the interventional peripheral world,” as so far all of his 27 patients, even dating back to five years ago, all have remained patent. He did not stent a single one of his patients, because he was able to stay in native vessel. This avoided stenting, and these stents can contribute to the arteries becoming blocked again quickly, and may require the patient to take medications for life.

Where does it fit in the doctors' toolbox?

Does it tackle all types of blockages, including ones others can't?

How does it align with a doctor's preferred approach to tackling arterial blockages?