PFor a long time, medicine has looked at the heart with a partial gaze. Large clinical trials, especially in the cardiology field, have predominantly involved men, leaving women on the margins of research. Today, however, something is changing. There gender medicine and the precision cardiology are opening a new phase: more careful, more targeted, more effective. It also proves it SMART study, promoted by Medtronicwhich for the first time puts the female specificities in the treatment of aortic stenosis. We talk about it with Paola Pirotta, Managing Director and CFO Italy, Senior Finance Director for Iberia and France.
A study designed for women: what changes now?
For years, women have been underrepresented in cardiac practices. What does it mean for a patient today to know that a study like SMART was designed especially for her?
«This is an important step forward – explains Pirotta -. For a long time, scientific evidence in cardiac surgery was based mainly on male populations, then adapting the results to women. The SMART study marks a change of perspective: is a large international clinical study that compared the main TAVR systems – the minimally invasive procedure used to replace the diseased aortic valve – in patients with smaller valve dimensions, a frequent condition in the female population. 87% of the participants were women.
Concretely, the study shows that there are solutions more suited to women’s hearts. This results in a valve that works better, facilitates the passage of blood and maintains good performance over time. It is an important step forward towards one medicine that is more attentive to differences and therefore more effectivebecause taking care of women means starting from what makes them unique.
Medtronic develops evidence to better understand the benefits of its technology in all patients, confirming its commitment to health equity and inclusive innovation. In this context, gender medicine is fundamental, as it allows for personalize care more effectively and inclusivelyresponding to the real needs of the entire population, not just the historically most represented majority.
The results showed that, although all are safe solutions, they don’t behave the same way in women which have smaller valves: some allow more effective blood passage and reduce the risk of the prosthesis being too “tight” after implantation.
Today gender medicine is medicine more precise, personalized, fair and effectivecapable of overcoming the approach that has standardized research by polarizing it on a predominantly male population and responding to increasingly growing and diversified health needs.”
Diagnosis and awareness: the role of precision cardiology
Many older women live with aortic stenosis without immediately recognizing the symptoms. How can precision cardiology improve diagnosis and awareness?
«Precision cardiology surpasses the idea that “one cure fits all”. It means better understanding how a disease manifests itself in a specific person, taking into account age, anatomical characteristics and clinical history.
In the case of aortic stenosis, women may have different characteristics that they require targeted therapeutic choices.
When research includes women, so does the diagnosis more attentive to their specificities and a more informed dialogue between doctor and patient, favoring informed and timely decisions. Medtronic’s SMART study is a concrete example of this vision. It aims to better understand how TAVI systems work in this specific population, being the largest post-marketing comparative trial on TAVR, with 87% female participants and over 80 centers involved worldwide.
The study provides evidence of effectiveness even for underrepresented populationsundiagnosed or inadequately treated. Medtronic continues to develop evidence to better understand the benefits of its technology in all patients, in line with global macro-trends that are transforming healthcare systems, such as patient centricity, personalized medicine and measurable and shared clinical value.
Gender medicine is today at the center of the institutional debate and of Pharma companies and is the first to position itself in the context of a MedTech company.”
Gender medicine: not just biology, but culture
Gender medicine is not only a biological issue, but also a cultural one. What still needs to change?
«Change must occur on multiple levels. Today, Medtronic is able to offer in addition to devices experiences, services and value to serve more people and in new and different ways.
In research, women must be included in clinical trials from the beginning. In treatment paths, gender medicine must not be conceived as a “medicine for women”, but an approach that takes into account how sex and gender influence symptoms, diagnosis and response to therapies.
Finally, we need a deeper cultural change: the differences are not exceptions to be managed, but a starting point. Talking about health equity means guaranteeing everyone the path best suited to their needs.
Furthermore, investments in Research and Development play a fundamental role. Medtronic are strong in this sense, we’re talking about almost 2.7 billion dollars and about 100 new technologies every year”.
Dr. Paola Pirotta, Medtronic
The message to women over 70
What is the message for women over 70 facing this procedure?
«I would say first of all that they are not alone. Today we have more knowledge and minimally invasive techniques that have changed the management of aortic stenosis. Studies like SMART help us better understand how these solutions work in women too.
The message is get informed, ask questions, participate in decisions. True innovation is not just technological: it is putting the person at the centre, with their history and their needs.
And this has always been at the heart of Medtronic’s mission: to contribute to human well-being by applying biomedical engineering to relieve pain, restore health and prolong the lives of people around the world”, concludes Dr. Pirotta.