Stories about: cardiac surgery

Pathways to market for medical devices

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You’ve got a great idea for a new medical device. After you’ve created the device and proved its usefulness in a clinical setting—a challenge in itself—the next step is getting your device to a commercial partner who can mass-produce and market it. Working through all of the regulatory hurdles, projecting the market for your product and figuring out your product’s long term potential can seem overwhelming.

“The more you know, the more prepared you will be,” says Pedro del Nido, MD, chair of the Department of Cardiac Surgery at Boston Children’s Hospital and principal investigator on the FDA-funded Boston Pediatric Device Consortium. “The more prepared you are, the more likely you will be successful.”

On January 6, 2015, from 5:30 to 7:30 p.m., del Nido will lead a panel discussion at Boston Children’s about moving medical devices from idea to commercial partnership,

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A portal for beating-heart surgery

Portal for beating heart surgery-analagous to mine entrance

When a patient needs a cardiac intervention, surgeons can choose to access the heart in one of two ways: open-heart surgery or a cardiac catheterization.

Open-heart surgery offers clear and direct access to the heart, but it also requires stopping the heart, draining the blood, and putting the patient on an external heart and lung machine. Catheterization—insertion of a thin, flexible tube through the patient’s groin and up into the still-beating heart—is less invasive. But it’s not suitable for very complicated situations, because it is hard to manipulate the heart tissue with catheter-based tools from such a far distance.

Both methods have been highly optimized, but each has its own risks, benefits and drawbacks. Wouldn’t it be nice if there were a way to directly access the heart and maintain normal heart function and blood flow while repairs are performed?

Nikolay Vasilyev, MD, thought so. A scientist in the cardiac surgery research lab at Boston Children’s Hospital, led by Pedro del Nido, MD, Vasilyev has designed a platform technology that may revolutionize the way we conduct cardiac interventions.

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Sticky heart: Novel surgical glue provides promising alternative for heart procedures

Surgical adhesive interacting with tissue
A close-up view of the adhesive (pink) interacting with collagen tissue (blue). Images courtesy Karp Lab.
A safe and effective adhesive, or glue, that can be used internally in the body has been a pressing need in medicine. Its creation has faced major hurdles—not the least of which is ensuring the glue is nontoxic and capable of repelling fluids—but a new study published today in Science Translational Medicine offers a potential breakthrough.

Congenital heart defects occur in nearly 1 in 100 births, and those that require treatment are plagued with multiple surgeries to deliver or replace implants that do not grow along with the child. Currently, therapies are invasive and challenging due to an inability to quickly and safely secure devices inside the heart. Sutures take too much time to stitch and can cause stress on fragile heart tissue, and the available clinical adhesives are subpar.

“Current glues are either toxic or easily washout in the presence of blood or react immediately upon contacting water,” says Pedro del Nido, MD, chief of Cardiac Surgery at Boston Children’s Hospital and senior co-author of the study. “The available options also tend to lose their sticking power in the presence of blood or under dynamic conditions, such as in a beating heart.”

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Building a whole heart for children born with half: Q+A with a cardiac surgeon

Could a new surgical approach help children like Lucas get the rest of their heart back?

Our pediatric heart surgeons are used to pushing the envelope. Last month we reported on a new kind of heart valve for children with mitral valve defects that can expand as they grow. Now the same team reports 10 years of experience trying to rebuild a lost half of the heart for children born with hypoplastic left heart syndrome (HLHS), a devastating, life-threatening defect.

The new strategy, called staged left ventricle recruitment (SLVR), seeks to harness a child’s native capacity for growth and healing to encourage the undersized left ventricle to grow, giving the child a fully functional heart.

I sat down with Sitaram M. Emani, MD—a cardiac surgeon in the Heart Center at Boston Children’s Hospital and lead author on the SLVR paper—to learn more. 

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New valves for babies that can grow with them

In children with severe mitral valve defects, sometimes valve replacement is the only option. Expandable mitral valves that can be enlarged as a child grows could make caring for such children less complex and invasive.

The human heart is kind of like a busy factory with two powerful pumps—the ventricles—and two “unloading docks,” called the atria. Together, these chambers maintain a delicate balance, ensuring that oxygen-rich blood moves out into the body and that oxygen-poor blood gets pushed back to the heart and lungs.

Just like any factory, however, the heart’s essential functions can be seriously disrupted if just one piece of machinery isn’t working properly.

The mitral valve is a key part of that mechanical balance. This one-way valve helps move blood from the left atrium into the left ventricle, which then pushes the blood out to the body. A failure of the valve can be life-threatening, but fixing or replacing it in children is incredibly complex—and often requires many repeat operations over time.

But two cardiac surgeons at Boston Children’s Hospital, Sitaram Emani, MD, and Pedro del Nido, MD, may have made the repair a little easier by developing a replacement mitral valve that can expand as a child grows.

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Defying orders to make heart surgery history

Lorraine Sweeney in 1963, on the 25th anniversary of her historic heart operation. (Children's Hospital Boston Archives)

When the first fetal cardiac surgery was performed at Children’s Hospital Boston in 2001 – entering Jack Miller’s heart through his mother’s abdomen and opening blood flow – the world was stunned. But more than 60 years earlier, another operation was equally game-changing.

It was 1938, a time before heart-lung bypass, when ether and chloroform were only starting to be supplanted by more controllable anesthetics, when tinkering with the heart or even opening the chest were seen as dangerous and taboo.

Tinkering was what Robert E. Gross, chief surgical resident at The Children’s Hospital, liked to do. He was interested in a congenital heart condition known as patent ductus arteriosus, a passageway between the pulmonary artery and the aorta that’s supposed to close after birth — but doesn’t.

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It’s just a hat: Simplicity in innovation

Clinical innovations don't have to be complex. Sometimes, as nurse Karen Sakakeeny has found, an innovation can be as simple as a hat (shown here on a doll). (Courtesy Karen Sakakeeny)

When we think about innovation, especially in health care, our thoughts often turn to the highly complex: new surgical procedures, new drugs, new devices or machines, etc.

But innovation in medicine and patient care doesn’t have to be complex. Sometimes it can be very simple. Like a hat.

Karen Sakakeeny has been a clinical nurse for more than 30 years, spending much of that time in the operating room. While doing a stint in cardiac surgery, she found herself thinking about ways to improve the rewarming process for infants undergoing open heart surgery.

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Guiding devices to market, and mending broken hearts

A biodegradable patch for repairing ventral septal defects (VSDs).

Imagine: You’re a pediatric cardiologist who for years has worked on the design of a device that could revolutionize the treatment of a severe atrial arrhythmia. But while you can find a lot of assistance and advice for bringing devices for adults to market, you find little help for devices intended for infants and children. What can you do?

The U.S. Food and Drug Administration could be your best friend. Better known for its role in establishing and enforcing regulations for drug and device safety and information, the FDA is also an advocate, helping bring innovative devices for pediatric treatment into clinical practice. Pedro del Nido, chief of cardiac surgery at Children’s Hospital Boston, outlined the FDA’s advocacy role last week at the monthly Innovators’ Forum hosted by the Children’s Innovation Acceleration Program.

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Beating-heart surgery and the search for a killer app

Concept for a new kind of surgical robot (click to enlarge)

Inventors and engineers tend to come up with ideas and technologies first, then say, “This is cool, what’s it good for?” Clinicians tend to say, “Here’s my clinical problem, how can I solve it?”

This was roughly the thinking that brought together Boston University engineer Pierre Dupont and Pedro del Nido, chief of Cardiac Surgery at Children’s Hospital Boston.

Dupont had a vision for a next-generation surgical robot. del Nido had a vision of doing complex cardiac repairs in children while their hearts are still beating. Could they create a viable technology?

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TEDMED here we come

Move over, Ozzy Ozbourne. Next Wednesday, October 27th, Children’s neurologist-neuroscientist and TEDMED speaker Frances Jensen will compare and contrast the developing infant brain with the highly paradoxical teen brain – which is also developing rapidly, all the way to age 25 or so. Infant and teen brains are at opposite ends of the developmental spectrum — almost different species, Jensen says – but they’re both extremely dynamic and exquisitely sensitive to environmental factors (drugs and alcohol in teens and brain injury and seizures in infants).

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