Author Topic: One of my inventions cured Atrial Fibrillation  (Read 6888 times)

Glowmaster

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One of my inventions cured Atrial Fibrillation
« on: April 04, 2016, 04:25:07 PM »
Hi Gang,

We spoke of this before on the site but officially the FDA approved my invention of visual guided laser ablation of Afib, from the company I founded in my basement.

CardioFocus' HeartLightŪ System Granted FDA Approval for Treatment of Atrial Fibrillation (AF)
More than 3,400 patients worldwide treated with HeartLight System to date

Validates definitive clinical results from U.S. multi-center pivotal study

09:15 ET from CardioFocus, Inc.

 

MARLBOROUGH, Mass., April 4, 2016 /PRNewswire/ -- CardioFocus, Inc. today announced that it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for its HeartLightŪ Endoscopic Ablation System for the treatment of patients with paroxysmal atrial fibrillation (AF).  The approved PMA submission contained comprehensive safety and effectiveness data from the Company's multi-center HeartLight U.S. Pivotal Clinical Study, a randomized, controlled study in which a total of 353 participants were randomized at 19 leading arrhythmia centers across the United States1.

Results from the pivotal trial, announced at Heart Rhythm 2015, showed that when performing a single ablation procedure using the HeartLight System, the majority of patients experienced freedom from paroxysmal AF at 12 months.  In addition, both the primary safety and efficacy endpoints were met.

AF is the most common cardiac arrhythmia affecting more than 33 million people globally, and an estimated 2.7-6.1 million people in the United States.  Catheter-based treatment of AF has created a market in excess of $1.5 billion, currently growing at approximately 15% annually, making it one of the largest and highest growth medical device market opportunities.

With the granting of PMA approval, CardioFocus becomes one of very few manufacturers possessing a specific indication for catheter ablation therapy of paroxysmal AF.  Specifically, in the United States, the HeartLight System is now indicated for the treatment of drug refractory recurrent symptomatic paroxysmal AF.   

The HeartLight System differs from other AF solutions that rely on x-ray or mapping support for guidance, by allowing the electrophysiologist to control the delivery of therapeutic laser energy, for the first time under direct visual guidance, to electrically and durably isolate the pulmonary veins (PVs).  The HeartLight System is designed to provide the clinician maximum procedural flexibility with a highly compliant balloon that easily accommodates diverse PV anatomies and laser energy that the clinician delivers under direct endoscopic visualization.

Co-principal investigator Andrea Natale, MD, FACC, FHRS, Executive Medical Director at the Texas Cardiac Arrhythmia Institute, Center for Atrial Fibrillation at St. David's Medical Center in Austin, TX commented, "This was a large study and the device clearly met both primary safety and efficacy endpoints.  I am confident these results, produced by physicians who were new to the laser balloon, demonstrate the promise of the HeartLight technology in routine clinical use." 

Further, co-principal investigator Vivek Y. Reddy, MD, Director of Cardiac Arrhythmia Services for The Mount Sinai Hospital and The Helmsley Trust Professor of Medicine at the Icahn School of Medicine at Mount Sinai observed, "Novel medical devices have a challenging path to approval and are evaluated through intensive comparison with control arm devices that are inherently more familiar to the study investigators.  The short learning curve of the new HeartLight System will enable even new users to quickly and efficiently deliver durable therapy to their patients."

Frank Cuoco, MD, FACC Associate Professor of Medicine, Division of Cardiology at the Medical University of South Carolina inCharleston, SC was one of the highest enrollers of patients in the HeartLight study, and added, "We are excited about the approval of the HeartLight endoscopically-guided laser ablation catheter.  Based on our experience in the CardioFocus pivotal study and the successful results from the EU, I am confident that this new laser balloon catheter will offer our patients an outstanding treatment option for atrial fibrillation.  The flexibility of the compliant balloon, which is intuitive to use under direct visual guidance, is one of its primary appeals.  I found the learning curve to be very short."

On behalf of CardioFocus, Vice President of Regulatory & Clinical Affairs Burke Barrett said, "The achievement of the HeartLight System PMA approval is a major milestone and the result of dedicated teamwork among our employees, the clinical sites and study participants, and we are grateful for this remarkable support.  It is also important to highlight the efficiency and professionalism of the FDA, reflected in this PMA review from filing to approval in eight months.  The HeartLight System represents a novel approach to ablation for the treatment of AF and we look forward to making it available in the U.S. for electrophysiologists and their patients."

The U.S. pivotal clinical study results are added to dozens of independent studies supporting the CardioFocus HeartLight System. Several published EU single-center studies have reported high rates up to 80% of freedom from AF recurrence measured one year or more after the performance of a single ablation procedure. To date, more than 3,400 patients worldwide have been treated using the CardioFocus HeartLight System.

CardioFocus is finalizing preparations to commercialize the HeartLight System in the United States.

About the HeartLightŪ Endoscopic Ablation System
The HeartLightŪ Endoscopic Ablation System is a unique catheter ablation technology designed for the treatment of atrial fibrillation (AF), the most common heart arrhythmia. The system incorporates an endoscope to provide physicians with the capacity to see within the heart, and for the first time, visually direct the application of laser energy to achieve durable pulmonary vein isolation.  In the United States, the HeartLightŪ System is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation. The HeartLightŪ System consists of the HeartLightŪ Catheter, the Endoscope, Balloon Fill Media and the HeartLightŪ Console.

About CardioFocus, Inc.
CardioFocus, Inc. is a medical device manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AF). The HeartLightŪ Endoscopic Ablation System is commercially available at leading institutions throughoutEurope and now in the United States. CardioFocus is headquartered in Marlborough, MA, USA.  For more information on the company and its technology, please visit www.CardioFocus.com.



I will never see a dime from it from the investors taking control but how many people can say they cured a major disease.

so I got that going for me....

stoneaxe

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Re: One of my inventions cured Atrial Fibrillation
« Reply #1 on: April 04, 2016, 04:30:39 PM »
Very cool...congrats. Would you please start working on something for screwed up shoulders..... :)
Bob

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Bean

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Re: One of my inventions cured Atrial Fibrillation
« Reply #2 on: April 04, 2016, 04:59:06 PM »
so I got that going for me....

Right on GM, that's huge in my book.

Glowmaster

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Re: One of my inventions cured Atrial Fibrillation
« Reply #3 on: April 04, 2016, 05:39:33 PM »
thanks.

I am probably more excited about getting my blueplanet Kai zen paddle today.

The cure took 20 years, 75 million dollars, 1 life lost.  After all that a new paddle is more exciting.  weird.

blueplanetsurf

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Re: One of my inventions cured Atrial Fibrillation
« Reply #4 on: April 04, 2016, 06:43:41 PM »
That's impressive but unfortunate that you won't get a paycheck out of it.
Glad you are excited about the new paddle!

Robert Stehlik
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Hawaii's SUP HQ
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juandoe

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Re: One of my inventions cured Atrial Fibrillation
« Reply #5 on: April 04, 2016, 07:22:58 PM »
Congratulations!  Does it lower the risk of esophageal injury?  I have seen a few esophagoatrial fistulas from ablations.  Bad problem to have.

supthecreek

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Re: One of my inventions cured Atrial Fibrillation
« Reply #6 on: April 04, 2016, 07:35:42 PM »
Way to go Ed.... just think of the suffering you will end! Nice work.

Like all artists.... now you have creds, the next disease you cure should pay off  :)

Wetstuff

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Re: One of my inventions cured Atrial Fibrillation
« Reply #7 on: April 07, 2016, 09:47:46 AM »
Cool Glow!   I may end up using your gizmo.  These days we patients walk in the door with a list of things we want the Doc to try.  I've only had AF a couple of times ..'prefer not to revisit.   Enjoy your new paddle. 

Jim
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JP4

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Re: One of my inventions cured Atrial Fibrillation
« Reply #8 on: April 07, 2016, 11:12:15 AM »
That's awesome! I've been battling Afib for several years. Nice to see there's another treatment option. Thanks!
JP

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Glowmaster

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Re: One of my inventions cured Atrial Fibrillation
« Reply #9 on: April 07, 2016, 11:22:26 AM »
wow, thanks Guys,

This could affect people in this group.  I didnt even think about that.

Here is a picture of the device.  The idea is to use an endoscope to look through the balloon and target a laser beam to make a circle around the pulmonary vein at the top of the atrium.  This is where the triggers come from. Electrically isolate the vein and the Afib is gone.  Sounds easy.

20 years,  >75 million dollars,  1 lost life (catheter puncture).  Long freaking road.

mrbig

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Re: One of my inventions cured Atrial Fibrillation
« Reply #10 on: April 07, 2016, 12:14:22 PM »
Good on ya mate. Next time we DW I'll enjoy your tunes even more!!
Let it come to you..
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tautologies

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Re: One of my inventions cured Atrial Fibrillation
« Reply #11 on: April 07, 2016, 01:33:26 PM »


Whats the story behind investors taking control? I am assuming several rounds of investments and perhaps a few deadlines passing?
Just interested since I am also dealing with investors.

Super cool invention for sure!!!!

Glowmaster

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Re: One of my inventions cured Atrial Fibrillation
« Reply #12 on: April 07, 2016, 02:54:55 PM »
Losing control is fascinating and painful.

Burning through $1M/month.  Always running out of money.  Every venture round screws the folks from prior rounds with "preferences".  Went from 94% of the company to less than 5% after 6 rounds.  Then new CEO makes a deal with corporate partner with "anti-dilution" clause.

When next round share price goes down the anti-dilution clause caused a cycle that somehow resulted in a 5000:1 reverse split.

Oh yeah and after they had all my patents assigned to them and I taught the staff how to do it, I was out on my ass.

But my name is still the first on the patent.

No investors in PhotoGlow.  Life is better.

surfcowboy

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Re: One of my inventions cured Atrial Fibrillation
« Reply #13 on: April 07, 2016, 07:25:57 PM »
Man, people never know how weird things get when companies start taking investment. Big problems take big budgets to solve.

I have never thought about the fact that in developing a medical device you can lose lives along the way. I cannot imagine the liability and feelings that go with that gig.

I appreciate your zen take on it all. As I struggle with my own startup it's nice to hear you sound happy and proud. Inspiring that you could change the world in this way. Best of luck on the next one.

tautologies

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Re: One of my inventions cured Atrial Fibrillation
« Reply #14 on: April 08, 2016, 01:29:48 PM »
Losing control is fascinating and painful.

Burning through $1M/month.  Always running out of money.  Every venture round screws the folks from prior rounds with "preferences".  Went from 94% of the company to less than 5% after 6 rounds.  Then new CEO makes a deal with corporate partner with "anti-dilution" clause.

When next round share price goes down the anti-dilution clause caused a cycle that somehow resulted in a 5000:1 reverse split.

Oh yeah and after they had all my patents assigned to them and I taught the staff how to do it, I was out on my ass.

But my name is still the first on the patent.

No investors in PhotoGlow.  Life is better.

Interesting. We are just through 1 round, so we are still good. It is unfortunate when investors do not understand the value of having the creative mind involved for future benefits. Sure your staff could work the specific innovation, and maybe build a bit on it, but the nexus of the innovation came from you.

There are some new types of stocks that protects minority stockholders and founders that are interesting and could have avoided the dilution to some extent.
I think our current stockholder would not do that even if they could, but once others comes into play you never really know what will happen. At least we have good / expensive counsel. haha.   

Anyway, looks like a killer invention....uhhhh not literally. 



 


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