About our project
This project is a finalist in the 2015 AHA NYC Challenge. Find and fund all the AHA finalists here and come see the winners at the Health Sciences Forum on April 22nd in NYC.
Thanks to the support of NYCBIO, all donations to this project are Tax Deductible. To learn more about NYCBIO, please visit NYCBio.org.
Overview
AblaCor is developing an innovative ablation solution for Pulmonary Vein Isolation (PVI) which clinicians believe will transform atrial fibrillation ablation procedures into a first-line treatment for millions of untreated or undertreated patients.
Figure 1: Example of Point Ablator and Ablation Procedure
Do 40% of all ablations for Atrial Fibrillation have to be repeated? – Development of Controlled Contact Ablation Catheter
What if your heart started to beat rapidly and irregularly. You started to feel weak, faint, short of breath. One cause is an electrical problem in the heart called atrial fibrillation or AFib. Atrial fibrillation is a progressive disease affecting 6 million people in the US and 30 million worldwide. It is the cause of 20% of all strokes and is linked to congestive heart failure (CHF). One treatment option is to ablate or burn tissue in the heart to isolate the faulty electrical area with a device called a catheter. The electrophysiologist (EP) controls the steering and position of the catheter from outside the body. Point ablator catheters in use today make it hard for doctors to keep the ablator electrode tip in contact with heart tissue during the ablation procedure, called pulmonary vein isolation (PVI) (see Figure 1). Failure to maintain adequate tissue contact can cause insufficient energy to be delivered into the targeted region. Irregular electrical signals can leak through gaps, causing an incomplete ablation and return of AFib. Currently, 2 out of every 5 of the 130,000 AFib ablations performed each year in the US are repeated. Our device, the CircumBlator catheter, maintains consistent, stable tissue contact. With one touch of a button, the CircumBlator system allows the EP to perform a complete ablation the first time. Our patent-pending system is designed to make ablation easier, faster, and more reliable for millions of patients with AFib.
How We Solve Atrial Fibrillation Ablation Problems
The CircumBlator™ system will help physicians perform a complete ablation the first time by maintaining consistent, stable tissue contact (see Figure 2 and 3). This will improve the quality of life for millions of patients suffering from debilitating AFib.
Figure 2.
Figure 3. CircumBlator Resulting Lesion
How the CircumBlator™ works:
What are the key features of the CircumBlator catheter? Why are they important? How does the catheter work? Catheters currently in use either leave gaps in the ablation lines due to movement of the catheter ablator tip during the ablation, or allow ablated tissue to recover. This can allow leakage of the irregular electrical signals into the left atrium. This can then result in AFib recurring and present an ongoing risk of stroke for the patient. There are key features that differentiate the CircumBlator catheter from other AFib ablation catheters and represent a major aspect of AblaCor’s innovation. One feature is the anchor positioned in the pulmonary vein. The anchor provides a stable platform for the umbrella ablator to be secured around the opening of the pulmonary vein (PV). Another feature is the ability of the ablator’s individual electrodes to adapt to the variable contours of the heart tissue around each PV. This ability allows constant and consistent contact throughout the entire ablation procedure. This will optimize energy delivery into the tissue and result in repeatable procedures that deliver complete ablations the first time. Once the electrophysiologist (EP) determines that the catheter electrodes on the umbrella ablator are properly positioned and are in contact with the heart tissue, he/she begins the ablation with one touch of a button. The system’s computer monitors the procedure and allows the EP to perform a complete ablation the first time. This procedure is repeated for each of the four PVs. We anticipate that procedure times will be about half the time of present procedures, patient outcomes will be significantly improved, and costs reduced with ablations performed with the CircumBlator system. Prominent electrophysiologists from world-class medical centers have endorsed the concepts for the CircumBlator.
Benefits of the CircumBlator™
- Improved patient outcomes for millions of patients
- Simpler and shorter procedures for physicians to perform
- Shorter learning curve for physicians to become proficient in the procedure
- Fewer readmissions for repeat procedures
- Reduced healthcare costs for treating AF
Clinical Proof to date
AblaCor has built prototypes of its catheter and a stabilizer apparatus to perform laboratory tests on tissue samples of cow’s liver. Early test results (see Figure 4) have been positive, showing that the CircumBlator catheter can produce consistent, continuous, linear lesions that are at least 4 mm deep, the average thickness of the atrial wall. The tests also demonstrate that the CircumBlator catheter can perform a complete ablation by employing stabilized, controlled contact on tissue without gaps in the ablation lines.
FDA Status
Prior to commercialization, AblaCor will apply for a CE Mark in Europe. Once the CE Mark has been obtained, AblaCor will gather clinical data and submit an application to the FDA, likely under pre-market approval (PMA) requirements.
How our solution helps AHA 2020 Mission – reduce cardiovascular disease and stroke by 20% by 2020
AFib is the cause of approximately 20% of all strokes. Forty percent of ablations are repeated at least once and many a second time due to incomplete ablations using current ablation technologies. This can result in recurrence of AFib. With its consistent ablator-tissue contact, precise energy delivery into heart tissue and enhanced feedback, the CircumBlator system will simplify ablation procedures. This will eliminate much of the complexity seen with current ablation catheters. The CircumBlator system will eliminate or significantly reduce the AFib burden and stroke risk following the first ablation procedure. Success in treating AFib may also reduce the incidence of congestive heart failure (CHF). We anticipate that additional physicians will be able to care for more untreated or undertreated patients. This is due to shorter procedures and fewer repeat ablations.
How We Help Patients
Leading EPs have informed us about their profound concern for patients who have recurring AFib following a first ablation. Recurring AFib is a burden to patients and their families because of the limitations it can present. A young father may be unable to play ball with his son. A working single mother can develop shortness of breath and faintness while driving to work. An elderly widow living alone can fall. A stroke for AFib patients not only can create severe impairment, it can be fatal. Our device, the CircumBlator system, will help the doctor perform an accurate ablation the first time. Stroke risk and congestive heart failure involvement will be minimized or possibly eliminated. Patients will enjoy the freedom from AFib symptoms and the burdens of this disease and associated clinical problems.
How We Help Doctors
Electrophysiologists (EP) report that pulmonary vein isolation (PVI), the cornerstone of all ablation procedures, is very complex, tedious, and time consuming. It is difficult to perform more than one ablation per day. It can take about 50 ablations for EPs to become proficient in performing this complicated procedure. Due to AFib recurrence, 40% of all procedures are repeated. The CircumBlator system affords the EP with an innovative approach to PVI ablation that will be safe, effective and efficient. It will provide the physician with the capability to create durable, continuous, transmural lesions with the goals of simplifying procedures, enhancing patient outcomes, reducing procedure times, and lowering procedural costs. The CircumBlator system addresses the fundamental problems with present PVI ablation methods of controlling contact, adapting to tissue variation, and providing appropriate feedback. It will transfer the art and skill of AFib ablation to a scientifically repeatable and reliable procedure.
Advantages of the CircumBlator are:
* Easier-to-perform PVI ablation
The CircumBlator catheter is designed to address the challenges reported by EPs. Its innovative features allow physicians to place the ablation electrodes at the appropriate locations in the left atrium and maintain
catheter stability and tissue contact throughout the procedure.
* Improved procedural efficacy
The CircumBlator catheter allows the physician to offer patients an ablation that eliminates atrial fibrillation the first time.
* Shorter procedure times will enable EPs to perform additional procedures per day.
* Reduced learning curve will enable EPs to become more proficient with fewer ablations performed
than with current technologies.
* Increased revenue potential as physicians can perform more than one procedure per day.
How We Help Hospitals, Institutions, and/ or Medical Facilities
CircumBlator will benefit hospital AFib ablation departments in the following ways:
- Increase number of patients successfully treated the first time;
- Increased revenue from higher procedure volume;
- Happier, stress-reduced EP staff.
In addition, we seek collaborations with educational and research institutions, with whom we can study and develop advanced features and benefits of the CircumBlator system and ablation procedures.
How We Help Our Partners
Other partners are payers, employers, families as well as strategic companies who develop, manufacture and sell products in this market. If patients have one procedure as planned with the CircumBlator system and become free of the burdens of atrial fibrillation, payers will be able to reduce procedural expenditures. Money previously spent on repeat procedures can then be spent on new patients receiving treatment. Employers will benefit by lower healthcare costs and reduced sick time by employees affected by AFib. More time can be spent on achieving company goals as well as increasing company output. Families will benefit as demands on their time, stress, and energy expended will be reduced. They will be happy that their family member returned to normal health. Strategic companies will be able to add additional, or new revenue sources for their sales force, in addition gaining advantage over competition.
How We Will Use The Proceeds of Funding
All raised funds will be utilized to build prototypes of the innovative CircumBlator™ catheter design in order to perform in vivo tests on live animal models. Funding will cover the cost of building next-iteration prototypes, performing animal studies, and the analysis of test results including tissue histology studies. Any additional funds raised will be applied to add to our patents. Successful results of initial live animal tests will confirm proof-of-concept. These advancements will increase the credibility of AblaCor and its CircumBlator™ system, making the company more attractive to investors. By participating in the Open Innovation Challenge, this will provide an excellent opportunity to advance AblaCor’s technology toward an improved treatment solution for atrial fibrillation and the anticipated decreased incidence of stroke and possibly CHF.
Who We Are
AblaCor’s founder, Martin Sklar, is a highly experienced developer of medical devices with over $1B generated for past developments. He has assembled a very accomplished engineering and business team, including ablation and catheter engineers with related experience in development of cardiac ablation devices. They are supplemented by consultants with medical, global commercialization, regulatory, and financial management expertise. Please see AblaCor’s website at www.ablacor.com for more details
Founders: Martin Sklar, Joyce College, Howard Ring, Robert Rioux, Robert St. John, Roy Wallen
Chief Medical Officer: Jeremy Ruskin, MD,
CTO / Engineering Lead: Robert Rioux, CTO
COO: Martin Sklar
How to Find Us:
Company Name: AblaCor Medical Corporation
Website: www.ablacor.com
Friend us on Facebook
Company Headquarters: Needham, MA
Tweet with Us: @AblaCorp
Project by: Martin Sklar, Master of Engineering, President & CEO
Linked In: www.linkedin.com/in/martinsklar/
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