“At the preclinical stage of medical device product development, there is an important opportunity to identify and implement significant improvements before first clinical use. T3 Labs provides extensive expertise and capabilities in the critical preclinical stage of medical device product development.” – Jason White, Senior Director of Product Development, St. Jude Medical
- 1.4 million patients in the U.S. have New York Heart Association (NYHA) Class III heart failure
- Historically these patients account for nearly half of all heart failure hospitalizations.
- According to the American Heart Association, the estimated direct and indirect cost of heart failure in the United States for 2012 was $31 billion, and that number is expected to more than double by 2030.
The CardioMEMS HF sensor is the first of its kind implantable wireless device implanted in the pulmonary artery to monitor pulmonary artery pressures.
In the case of any innovative medical device, especially for a highly complex, first-of-its-type FDA Class III device (one that is “life supporting, life-sustaining or important in preventing impairment of human health”), the regulatory development requirements are necessarily stringent and the stakes are high for all concerned: the patients whose lives stand to benefit, the innovators themselves, the investors and even the regional medtech innovation ecosystem which can blossom quickly under the right conditions.
The preclinical challenges for CardioMEMS
“Preclinical Research” describes the second of seven stages of the medical device development process. The aim of a preclinical study is to collect data in support of the safety of a new medical treatment or device. Preclinical studies are required before clinical trials in humans can commence.
In addition to satisfying regulatory requirements for preclinical studies before successfully advancing into the next stage of the product development lifecycle, the CardioMEMS team needed to:
- Determine how best to configure the implant to advance from concept to prototype.
- Determine precisely where to place, how to anchor and how to deliver the sensor.
- Perform GLP studies required to achieve investigational device exemption (IDE) needed to begin clinical trials in humans.
- Develop implantation and training procedures.
The solution: High value preclinical services essential to medtech innovation – “The testing team operates in the same clinical setting [at T3 Labs] in which cardiologists currently use the CardioMEMS HF system. This is a critical step in understanding how your product is going to perform in use.”
Informed by decades of experience, insights and technical expertise T3 Labs possesses a holistic view of medical product development from concept to cure. T3 has archived more than 50 GLP studies for leading medical device manufacturers from which more than 30 products have received regulatory approval including the CardioMEMS HF System. T3’s preclinical testing and training program leaders are trained scientists, too. They understand and participate in the science and methods behind therapeutic options, not only those in the cardiothoracic/cardiology space, but various other surgical/non-surgical models and devices.
“Our experience with T3 Labs for the CardioMEMS device created new knowledge and refinements to the device that resulted in a product that was highly mature at the time we started our clinical trials in humans. During our preclinical work with T3, the concept for the sensor was refined from being attached to the right ventricular septum with an anchor coil to one that is placed in the distal pulmonary artery passively anchored by wire loops. Iterative refinement resulted in an optimized configuration for ease of use during the implant procedure and long term safety. T3 labs provided the ideal environment to identify the optimal configuration prior to first clinical use,” St. Jude Medical Senior Director of Product Development Jason White says.
T3 has invested in 7 state-of-the-art procedure areas including 3 operating rooms on par with the top hospitals in the country. Both T3 and St. Jude Medical are located in Atlanta.
“The T3 Labs team possesses high levels of capability with vascular procedures and state-of-the-art equipment and facilities providing solid, real world operating conditions,” White says. “The testing team operates in the same clinical setting in which cardiologists currently use the CardioMEMS HF system. This is a critical step in understanding how your product is going to perform in use. It is a step in the process that should get a lot of attention.”
T3 Labs knows preclinical research. T3 has archived more than 50 GLP studies from which more than 30 medical products, including the CardioMEMS HF system, have cleared the FDA approval process.
“There are significant portions of preclinical and GLP requirements that the T3 Labs team knows that we don’t: not only in their knowledge of study subjects, and administration of a GLP study, but also follow up tests and biometrics that are commonly included in regulatory submissions. The CardioMEMS team includes T3 Labs in our new device protocols because of their industry leading knowledge of regulatory requirements for preclinical and beyond.”
Jason White, senior director of product development, St. Jude Medical
The results: from concept to first-in-human
- After filing the IDE (Investigational Device Exemption) with FDA which included data collected from T3 Labs, CardioMEMS received its letter of approval to begin clinical trials in humans.
- After submitting its premarket approval application to the FDA, CardioMEMS received its letter of approval to begin commercial distribution on May 28, 2014.
- The CardioMEMS HF sensor(1) is the first of its kind implantable wireless device implanted in the pulmonary artery to monitor pulmonary artery pressures.
- Following a six-year, $100 million development process, St. Jude Medical completed its acquisition of CardioMEMS for a total of $435 million.
Given the success of the CardioMEMS program and the potential for pressure monitoring in other applications, St. Jude Medical and T3 Labs are currently collaborating on the “next gen” products currently in the concept stage. If your medical device company is seeking a flexible, reliable, innovative partner committed to learning and maximizing your investment in preclinical trials, contact firstname.lastname@example.org or call +1 (404) 251-0600.