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CARDIOVASCULAR
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Interview With Michael Fonseca, Director Of Product Development

Michael Fonseca, currently Director, Product Development, Hemodynamic Monitoring, is also a founding team member of CardioMEMS™ HF System, an implantable Pulmonary Artery (PA) pressure sensor that is a life-changing technology for many heart failure patients. After a patient is implanted with the CardioMEMS HF System, remote monitoring is set up with the Merlin.net™ Patient Care Network (PCN) and the myCardioMEMS patient app. The CardioMEMS HF System is the first and only FDA-approved wireless heart failure (HF) monitor that has been proven to significantly reduce heart failure hospitalizations1, reduce mortality2 and improve quality of life3.

 

Can you give us a bit of background on yourself and how you found yourself on the CardioMEMS founding team?

I’ve always loved learning, solving puzzles, and doing things others considered hard. Because of that, I was drawn to electrical engineering and ended up focusing on micro electro-mechanical systems, which is the technology CardioMEMS is based on. For those who don’t know, MEMS is an acronym for a type of technology – micro-electronic mechanical systems. It is based on semiconductor and fabrication technology and is about how to make really, really small machines do something useful. Although the acronym uses the word mechanical, MEMS covers a wide spectrum of devices, from optical, chemical, mechanical, etc. It’s a way of using micron-scale devices to interact with the physical world. The technology is rooted in semiconductor processes developed for computer chips and microprocessors.

Toward the end of my undergraduate degree, I worked as a research assistant in one of the country’s top MEMS research centers at Georgia Tech led by Dr. Mark Allen. I was assisting a Ph.D. student in the area of high-temperature pressure sensors for turbine engines. I was fascinated by MEMS and applied to graduate school at Georgia Tech to continue the research. At the same time, CardioMEMS - the company- was being incorporated, and I joined as the first sensor R&D engineer. Over the following 12 months, we hired a small team of founding members comprised of engineers, quality and regulatory staff.

 

What were the early days of CardioMEMS like?

Early on as a startup, we faced a lot of challenges bringing products to market. It wasn’t just the challenge of building a company with all the right pieces and people, but there were technology challenges as well. The hardest thing we did was create the CardioMEMS sensing platform since it was a first. The system required a wireless implantable sensor without a battery, external electronics, a delivery catheter, and the website database. This challenge was then surpassed by an FDA PMA clinical trial and approval.

It was incredible to create a market from scratch and ultimately impact patients’ lives every day. CardioMEMS has been on the market for six years now.

 

Knowing it was a “first,” was there a specific moment during development of CardioMEMS that felt like a technological breakthrough?

Many of the hardest challenges had to do with the technology being so new. There wasn’t a reference point, so we had to discover it on our own. In that way, the whole project felt like a breakthrough. More specifically, the sensor was a challenge. Making it perform over a patient’s lifetime was tough. In a different way, the electronics were also challenging because the signal power returned from the sensors was extremely low. Additionally, we couldn’t regularly access it due to the implant location, which meant we couldn’t recalibrate at all or very infrequently.

 

Has there been specific feedback provided by clinicians that has helped shape product development or prototypes?

When the technology was being created, very few individuals on earth had access to continuous or intermittent pressure data from heart failure patients outside the hospital. The idea of getting pressures every day was brand new, as was the idea of doing this type of monitoring remotely. There was one product before CardioMEMS that attempted remote pressure monitoring, but it did not get approved. We learned a lot from that product and the clinicians involved with it. It was a learning process between the clinicians and us to put it all together in a meaningful way, everything from the creating the delivery system and optimizing it to be similar to other procedures as well as developing the web interface, Merlin.net.

We recently launched the next generation of Merlin, version 10.0. Compared to what we originally launched, it’s much better at providing efficient pressure information at the right time for the right patients, without clutter. Feedback from nurses at several clinics really helped us, and the new interface is a direct result of their feedback.

 

What’s important in the R&D process?

Determining what tomorrow’s customer is going to want in the next iteration is important, which includes figuring out what features are missing that they may or may not know about. Working closely with our customers and their patients to make sure we understand the current and future needs is a key step of the process. In R&D, once you get past the “does it work?” question, it becomes about product development. Is this idea or prototype replicable, reliable, and consistent?

 

What makes CardioMEMS, or any other product, a life-changing technology?

For me, life-changing technology doesn’t just save lives but also improves quality of life, including getting patients out of the hospital.
CardioMEMS is helping physicians change the lives of their patients by giving insight as to what’s going on inside the body in a way that wasn’t possible before. Until CardioMEMS, physicians would plan a patient's medical management based on general guidelines and rely on weight and symptoms, which are poor predictors of worsening heart failure. They didn’t have direct feedback as to what worked best for that individual patient. CardioMEMS provides early and direct feedback into how the medical management is or is not working at an individualized level.

 

What’s next for the CardioMEMS team?

We are working on the next generation of CardioMEMS technology with the Mechanical Circulatory Systems team. We’re learning from each other how to apply these different but complementary technologies. There is also interest in collaboration with other divisions such as Abbott diagnostics. Overall, our team is looking at opportunities internally to align more heart failure products, which you will likely see in the future.


 

Visit cardiovascular.abbott for more information about the CardioMEMS System including recent studies, clinical uses, and more.

 

References
  1. Shavelle DM, Desai AS, Abraham WT, et al. Pulmonary Artery Pressure-Guided Therapy for Ambulatory Heart Failure Patients in Clinical Practice: 1-Year Outcomes from the CardioMEMS Post Approval Study. Presented at: ACC; March 17, 2019. SJM-MEM-0419-0510
  2. Abraham J, Bharmi R, Jonsson O, et al. Association of Ambulatory Hemodynamic Monitoring With Clinical Outcomes in a Concurrent Matched Control Analysis. JAMA Cardiol. Published online May 15, 2019. doi:10.1001/jamacardio.2019.1384
  3. Abraham, W. T., Adamson, P. B., Bourge, R. C., Aaron, M. F., Costanzo, M. R., Stevenson, L. W., … Yaday, J. S. (2011). Wireless pulmonary artery haemodynamic monitoring in chronic heart failure: A randomised controlled trial. The Lancet, 377(9766), 658-666. n=550. http://dx.doi.org/10.1016/S0140-6736(11)60101-3


 

INDICATIONS, SAFETY AND WARNINGS
INDICATIONS, SAFETY & WARNINGS

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Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

Indications and Usage: The CardioMEMS™ HF System is indicated for wirelessly measuring and monitoring pulmonary artery (PA) pressure and heart rate in New York Heart Association (NYHA) Class III heart failure patients who have been hospitalized for heart failure in the previous year. The hemodynamic data are used by physicians for heart failure management and with the goal of reducing heart failure hospitalizations.

Contraindications: The CardioMEMS HF System is contraindicated for patients with an inability to take dual antiplatelet or anticoagulants for one month post implant.

Potential Adverse Events: Potential adverse events associated with the implantation procedure include, but are not limited to, the following: Infection, Arrhythmias, Bleeding, Hematoma, Thrombus, Myocardial infarction, Transient ischemic attack, Stroke, Death, and Device embolization.

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