Micro Interventional Devices, Inc.
Safe Percutaneous Interventions Emulating Surgical Efficacy

Minimally invasive and percutaneous procedures are becoming increasingly viable alternatives to invasive surgery in the management of heart disease. Over the last few decades breakthroughs in the treatment of coronary artery disease and structural heart disease have resulted in the development of innovations such as the coronary stent, transcatheter aortic valve replacement (TAVR) technologies, transcatheter mitral valve repair (TMVr) technologies and similar devices for treating patent foramina ovalia and other heart diseases. These advancements in medicine are driving a radical change in the continuum of cardiovascular care. Recognizing this disruptive technology trend early on, Micro Interventional Devices (MID), a medical device company that develops minimallyinvasive solutions for structural heart disease, is forging new ground with percutaneous tricuspid and mitral repair procedures that eliminate the need for open-chest bypass surgery traditionally required for treatment of these diseases.

“Our aim is to develop simple, safe and secure solutions for tricuspid and mitral regurgitation, replicating standard of care surgical outcomes on the end of a catheter, while simultaneously addressing challenges that cardiologists, cardiovascular surgeons, and echocardiographers often face using minimally invasive techniques,” says Michael Whitman, Founder, President and CEO of MID.

MID is focused on facilitating the paradigm shift from complex open surgical procedures to fully percutaneous, image-guided solutions. Addressing complex disease states requires an in-depth knowledge of the current standard of care and specific attention to each patient’s unique anatomy. MID’s revolutionary products move these procedures from the operating room to the catheterization laboratory, reduce the overall morbidity and mortality, with the added benefit of shorter procedure time and a reduction in recovery time for the patient. In addition, this approach puts the treatment in the hands of more specialists, as there are many more practicing cardiologists than there are surgeons.

Starting With A Baseline of Knowledge

Today, repairing the annulus of the tricuspid or mitral valve requires suturing. MID believes that an in-depth understanding of why open surgery is successful, combined with comprehensive knowledge of catheter performance and imaging, is critical to treating these diseases percutaneously. After years of applying this combination, the company has created a product that is customizable to the anatomy of each patient. The technology does not rely on a single prosthetic shape or structure (implant) that would require the patient’s anatomy to adapt to the technology, as is the case with a transcatheter valve for example. MID’s approach allows the natural incorporation of the implant into the native valve tissue to initiate natural healing and re-shaping of the tissue unto itself.

“Having spent over thirty-five years in the medical device industry exposed to surgical techniques and procedures, we knew that developing a product that was the least invasive to the patients native anatomy, had little foreign material left behind, was customizable to each unique anatomy, and did not interfere with cardiac wall-motion, would be the prevailing technique,” says Whitman. “We believe our simple, safe and secure solution will end up being the technology of choice for first-line treatment of tricuspid and mitral disease.”

MID works to make its technology simple and safe, because a simple, safe procedure can be more widely adopted. If it’s durable and highly effective, it becomes the standard of care.

The company’s proprietary PolyCor anchor, which required 61 iterations to perfect, was specifically developed for these structural heart disease indications.

Polycortm Anchors – The World’s First Polymeric Anchor Designed for The Heart

The secret sauce behind the company’s ability to replicate surgery and customize the results to each patient lies in the development of the proprietary PolyCor anchor.

The management team at MID has been in the cardiovascular industry for decades. The team had the foresight from years of industry experience to know that the stent-based tools developed to address the popular transcatheter aortic valve replacement (TAVR) procedure would not work well in addressing tricuspid or mitral disease. The tricuspid and mitral valve anatomies are not concentric like the aortic valve, and require tailored solutions.

Whitman and his team set out to develop the PolyCor anchor with the clear objective of replicating open heart surgery on the end of a catheter using remote tissue fixation. PolyCor is an ultra-low mass, polymeric anchor that has a firm, yet delicate foothold in tissue as compared to the metallic, aggressive anchors used in orthopedics. With ‘poly’ for polymer and ‘cor’ meaning of the heart in Latin, PolyCor is the world’s first soft tissue anchor for transcatheter cardiac repair procedures (TCR).

The PolyCor anchors are deployed into the tissue with high speed delivery catheters in 4/1000ths of a second. Because the low-mass anchor lacks any strength unto itself due to its light and flexible nature, MID designed a high-speed delivery system to drive the “light-as-a-feather” anchor into the moving annular tissue. This concept is reflected in the design of their logo; an archer releasing an arrow. When the PolyCor anchors are deployed into the tissue they become integrated into the annulus and work in symbiosis with the tissue. The velocity not only ensures the anchor is accurately seated in the tissue, but allows for fast procedure times as well.

Once the anchor is deployed into tissue, the compliant PolyCor anchor flexes when pulled, ensuring it remains well-seated in the valve annulus. Although the anchor only weighs 0.005 grams, it is able to withhold over four Newtons of pull-out force. It does not tear the tissue; it moves with it. PolyCor is designed to encourage an environment of symbiosis where the polymeric anchor works with the body to correct the structural heart defect and heal the tissue that has been repaired. It took MID deep insight and years of understanding to grasp the intricacies of how to handle these soft, delicate tissues. Ultimately, it resulted in a sophisticated technology that is simple to use.

The PolyCor anchor is the key component in the MIA-T Percutaneous Tricuspid Annuloplasty System, which the FDA has designated a “breakthrough technology.” The MIA-T technology is a 12 French catheterbased system. It is extremely low profile, which makes it far more maneuverable than other catheterbased systems being developed. The distal end of these catheters have a unique feature called ‘stabilizing pins,’ which temporarily affix the distal end of the catheter to the annulus to ensure the correct orientation and placement of the anchor into the tricuspid annulus.

Once the PolyCor anchors are placed around the annulus, the anchors are drawn together to affect an annuloplasty, reducing the tricuspid valve area and ultimately reducing tricuspid regurgitation.

MID’s innovative solution has enabled this surgical gold standard for tricuspid annuloplasty to be performed off-pump in a catheterization lab through a percutaneous puncture in 31 patients to date. The STTAR, Study of Transcatheter Tricuspid Annular Repair, clinical trial in Europe, has demonstrated the safety and performance of the technology for percutaneous tricuspid repair.

MID is currently anticipating receiving CE mark approval for the MIA-T system by early 2023, after which the product will be commercially available in Europe.

Simple, Safe And Secure Tool Box for Treating Structural Heart Disease

It is evident that knowledge across core competencies is vital to delivering safe and reliable treatment technologies to the marketplace. Just as essential is a team of experienced and dedicated people who share their insights across the spectrum of delivery of the technology, from design and development to launch. The MID team has it all–with a collective one hundred plus years of insight in cardiovascular medicine alone.
The MID team works in collaboration with key leaders in the field, including physicians from NYU Langone Medical Center, Columbia University Medical Center, the Hospital of the University of Pennsylvania, the Mayo Clinic, and many more esteemed hospitals, in conjunction with the FDA and notified bodies in Europe. A committed team of dedicated individuals, each serving a critical function, is what brings MID’s technology to patients in a safe and expeditious manner.

Our Aim is to Develop Simple, Safe and Secure Solutions for Tricuspid and Mitral Regurgitation. Presently Surgery is The Standard of Care for the Treatment of Tricuspid and Mitral Regurgitation. These Surgical Techniques Have Demonstrated Effective Outcomes for Decades. Replicating Surgical Outcomes Percutaneously (On The End of a Catheter), While Simultaneously Mitigating Procedural Challenges is Our Objective

In the coming months, MIA-T will be adapted to treat mitral regurgitation. The company has completed preclinical testing of the MIA-M system for mitral repair and the first in human procedure is imminent. “Despite being compact in size, the PolyCor anchor is revolutionary as it has applications in an expansive technology platform that can facilitate the transcatheter replication of many different surgical procedures,” says Whitman. Mitral regurgitation is the next indication after tricuspid regurgitation that will be treated with the PolyCor anchors.

MID plans to pursue additional applications beyond MIA-T and MIA-M, expanding the company’s toolbox approach to treat patent foramen ovale, left atrial appendage, and chordal repair. The company aims to convert many structural heart repair procedures currently involving sutures in open surgical repair to be performed using percutaneous techniques. To that end, MID is developing an innovative product line, adapting the PolyCor anchors and their delivery systems to address multiple structural heart repair applications. One day there will ultimately be a PolyCor-based tool box for treating a wide range of structural heart diseases.