Structural Heart and Aortic President Nina Goodheart shares how Medtronic seeks to save more lives through its SMART trial and development of gender-sensitive medical devices.

The exclusion of women from clinical trials for decades has resulted in a staggering lack of data and understanding about their health.

This historical oversight has had profound consequences on the treatment and diagnosis of cardiovascular disease in women, Medtronic SVP and Structural Heart and Aortic President Nina Goodheart said in an interview at DeviceTalks Boston 2024.

“We are facing a crisis in women’s health, and it’s imperative that we use every tool at our disposal to address it,” she said.

Historically, cardiovascular care focused predominantly on men, leading to a systemic exclusion of women in research and treatment. This bias was cemented in the 1970s after the thalidomide crisis, which prompted the FDA to ban the inclusion of women of childbearing age in early-phase clinical trials. Even preclinical studies were primarily conducted on male animals to avoid the complexities of female hormones.

“For about 20 years or so, there were no studies of women,” Goodheart said.

It wasn’t until the 1990s that pioneering cardiologist Dr. Nanette Wenger pushed the National Institutes of Health to mandate the inclusion of women in clinical trials. The American Heart Association’s Go Red for Women campaign in the early 2000s further increased awareness, leading to a decrease in female cardiovascular deaths. However, recent data shows a renewed uptick in fatalities among women.

Women often present with different, less recognizable symptoms, leading to delayed diagnoses and missed opportunities for life-saving treatment. And physicians don’t take women and their symptoms as seriously as they do for male patients, Goodheart said.

“We’ve got to do better taking care of 50% of the population,” she said.

Goodheart and Medtronic are trying to rectify the imbalance and save more lives. To close the gap, they’re using findings from a clinical trial and real-world evidence (RWE) to develop gender-sensitive medical devices.

Key challenges in inclusive trial design

One of the biggest barriers to improving women’s cardiovascular outcomes is their reluctance to participate in clinical trials. This is due to a lack of representation in trial design, mistrust of predominantly male clinical environments, and societal factors that discourage women from seeking care.

“If we want better outcomes for women, we need to make trials more inclusive and address the systemic issues that keep women out,” Goodheart said.

Medtronic is partnering with associations, physicians, and even competitors to make trials more inclusive. Medtronic has also introduced patient education initiatives to increase trust and awareness, helping more women understand the importance of trial participation and encouraging them to seek care earlier​.

“It’s not just about getting more women to participate,” Goodheart said. “It’s about designing trials that take into account the real-life experiences of women and other underrepresented groups.”

The SMART trial: Engineering solutions for women

Traditional clinical trials have historically been conducted in controlled environments with limited diversity, making it difficult to assess how devices work for a broad population.

The Small Annuli Randomized to Evolut or Sapien (SMART) trial is different. It’s an international study led by Medtronic, designed to address a significant gap in cardiovascular care by comparing the performance of Medtronic’s Evolut valve and Edwards’ Sapien valve in women versus men​.

Goodheart described the trial as “bringing together engineers, physicians, and researchers to generate data that are inclusive of the female population.”

“We’re not just looking at gender,” she said. “We’re also considering other demographics like age, ethnicity, and lifestyle factors. This gives our engineers a deeper understanding of how to design devices that perform optimally for all patients, not just the average male.”

Medtronic’s engineers have taken these insights to heart, developing new cardiac valves and stents specifically for women, whose arteries tend to be smaller than men’s. This miniaturization requires meticulous precision without compromising effectiveness, an ongoing challenge that Medtronic is actively addressing, Goodheart said.

The trial also sheds light on the importance of creating devices that account for women’s unique hormonal fluctuations, which can affect healing and integration with implants.

How RWE is driving change in medical device engineering

One of the most impactful aspects of the SMART trial is its use of RWE, Goodheart said.

“Traditional clinical trials are often limited in scope and don’t capture the full range of patient experiences,” she said. “RWE allows us to see how devices perform outside of controlled conditions, which is crucial for understanding how they will work in the real world.”

For engineers, the use of RWE means they can design with confidence.

“We’ve been able to identify gender-specific trends in device performance, allowing us to make real-time adjustments that improve outcomes for women,” Goodheart said.

For example, heart valves engineered with data from RWE are now being designed to accommodate the unique physiological needs of female patients, like those differences in artery size and tissue elasticity

And because women’s bodies change over time due to factors like pregnancy and menopause, which can affect how devices perform, it’s essential to develop more adaptable devices.

“Our goal is to create devices that can adjust to these changes, offering women better outcomes no matter where they are in life,” she said.

Beyond individual device adjustments, RWE is guiding broader engineering strategies. Medtronic is using data from the SMART trial to develop more durable materials for heart valves for longer durability.

“Women live longer than men on average, which means their devices need to last longer and perform reliably over time,” Goodheart said.

This insight has led to the development of more robust valves that not only reduce the need for future surgeries but also improve patient outcomes and overall healthcare costs.

Other major device developers are also leveraging RWE to make their devices more inclusive. This shift toward data-driven design is setting a new standard prioritizing patient diversity and long-term outcomes.

“RWE is more than just data,” Goodheart said. “It’s a tool for innovation.”

Resources on women’s cardiovascular health

Goodheart offered several resources during her DeviceTalks West talk:

• American Heart Association: Women and Heart Disease
• Society for Women’s Health Research: Women’s Health Resources
• Medtronic SMART trial overview: Medtronic Clinical Trials
• CDC cardiovascular disease statistics: CDC Heart Disease Facts