Improving patient care with new technologies is critical to continue to improve procedural outcomes and patient quality of care. In recent years, there has been significant evolution in many spaces within the medical field that have benefited both patient outcomes as well as providers’ ability to deliver top care.
Many of these advancements have come with a greater focus on integrating technology into medicine. Palliare, a company that is innovating in the insufflation space, is working toward creating a safer operating environment that provides better physician control and patient outcomes.
We had the opportunity to speak with Palliare CEO John O’Dea to learn more about this cutting-edge company and the man behind its vision.
The Company’s Inception and Efforts
Palliare is an organization that has been a highlighted name in the healthcare sector. CEO John O’Dea has a legacy and reputation for being a leader in creating solutions to challenges that medical professional face during surgical and endoscopic procedures.
Before Palliare, John founded a company called Crospon, which operated in the endoscopy space and was later acquired by Medtronic (NYSE: MDT) in 2017. During this period, he spent ample time observing advanced endoscopic procedures. In the last two decades, he observed the shift in endoscopy from being purely diagnostic to providing surgical treatments.
Insufflation, where gases are injected into the surgical cavity, had been left untouched and was not being evolved to meet the needs of these more complex and longer endoscopic and laparoscopic procedures.
Regarding this concern, John says, “In the same period, we have seen the evolution of laparoscopic surgery to robotic surgery. Similarly, insufflators have only started to evolve to meet the emerging needs of these procedures — particularly concerning managing smoke evacuation and leaks from trocars.”
From this observation, an opportunity was born to innovate in the insufflator space and provide a safer environment and better control for physicians conducting these cases. The company created a compact insufflator tailored to the evolving needs of endoscopic, laparoscopic, and robotic surgery.
An engineer by trade, John spent his early career working for Puritan Bennett, where he designed ICU ventilators. Later, in 1998, he co-founded Caradyne, which developed non-invasive ventilation products for ER and NICU settings. The company was acquired in 2004 by Respironics (NASDAQ: RESP). In 2007, he founded Crospon, which developed a novel diagnostic product called EndoFLIP. This device assesses sphincter performance and motility in the gastrointestinal tract. This company was acquired by Medtronic in 2017 (NYSE: MDT).
John shares, “In 2018, a year after Medtronic acquired Crospon, I founded Palliare. We received FDA clearance for its flagship insufflator device, EVA15, in 2020. We offer two leading solutions: the EVA15 and the EndoTrap, and our vision is to continue to evolve the EVA platform to bring more innovations in surgical and endoscopic insufflation to market.”
Products, Services, and Their Impacts
The EVA15 insufflator and smoke evacuation system provides best-in-class laparoscopic, robotic, and surgical endoscopic insufflation. It meets AORN guidelines on surgical smoke evacuation, which is important to support the safety of the OR and endoscopy suite staff and adhere to a recent legislative drive to ban surgical smoke in the OR.
During the pandemic, John’s well-known legacy of innovation brought him and Palliare a new opportunity. He shares, “In 2020, during the COVID-19 crisis, we were selected by the European Commission to design devices to reduce potentially contaminated gases emitting from the patient during surgery and endoscopy. The project, called PORSAV (Protecting OR Staff From Aerosolized Virus), was completed in July 2022. Two devices, EndoTrap and LeakTrap, were developed by the project consortium for which Palliare was the technical lead.”
EndoTrap was born during COVID-19 but continues to have a strong role beyond it. The device is designed to improve staff safety by reducing exposure to airborne particles during upper endoscopy and bronchoscopy procedures. A protective barrier is created around the patient’s nose, mouth, and endoscope using a single-port anesthesia mask and viral filter, along with the EndoTrap, which consists of a T-piece, a valve, and a protective sleeve. EndoTrap is intended to be used during high-risk bronchoscopy and upper GI endoscopy procedures.
The company’s main product, EVA15, is an insufflator with a built-in smoke evacuation system. Any surgical smoke removed from the patient is filtered through an ultra-low particulate (ULPA) filter, which can trap particles down to 0.04um in diameter. This is important to protect OR staff from smoke produced during these procedures.
While talking about the EVA15, John adds, “A key aspect of the EVA15 design is that when smoke is evacuated from the surgical cavity, fresh gas is injected into the cavity so that the surgeon experiences no collapse or reduced visibility. Pressure is sampled 100 times per second so that the response to evacuation is almost instantaneous and there is no perceived change in the pressure.”
Envisioning the Future
In the coming years, Palliare is focused on moving the insufflation field forward with exciting developments in intelligent insufflation, such as advisory capabilities to guide surgeons to the optimum insufflation pressure, thus reducing the risks associated with hyper-insufflation.
Stating the primary goal of Palliare, John says, “We will be exploring these techniques with the anesthesiologist community, not only for the perioperative phase of a procedure but also with a focus on exploring whether or not smart insufflation can reduce postoperative pain for patients. The company has a lot of exciting innovation goals that will make procedures safer for the medical community and help improve patient outcomes.”
The company is seeking to bring to market the world’s first bi-level insufflator to allow insufflation pressures to be quickly changed intra-procedurally, a feature of central importance in new, emerging endoscopic surgery procedures.
Challenging and Changing the Scenario
There is a strong legislative agenda, particularly in the U.S., to ban surgical smoke in the operating room. Many insufflators can’t keep the pressure consistent when gas is extracted by standalone smoke evacuation. As a result, surgeons experience a compromised surgical field due to decreased visibility when the gas is removed.
This technical issue has caused major concern in the OR. Everyone agrees surgical smoke is dangerous, but so is forcing surgeons to operate with sub-optimal visibility during a procedure.
A newer insufflation technology, like EVA15, eliminates this compromise and facilitates both a safer environment for the surgical staff with proper smoke removal and a safer procedural environment for the physician and patient. It does this by consistently delivering the correct pressure, thus keeping clear visibility during the procedure.
John adds, “We have worked with AORN to produce an accredited CE course, Understanding the Challenges of laparoscopic Insufflation, to educate the OR community on how the smoke evacuation and insufflation systems can be designed to operate to meet the needs of all staff in the OR.”
Many smoke evacuators operate continuously, regardless of whether or not smoke is being generated. This leads to continuous CO2 being pumped into the OR. As Palliare looks to the future, it is seeking to make this a safer environment for all involved. John adds, “We are working on the way to have a surgical robot or energy system inform the insufflator when it needs to turn on and off smoke evacuation to reduce the unnecessary CO2 produced and emitted during a procedure.”
Using Emerging Technologies
“As the company’s founder, it is my focus to continuously develop, innovate, and advance the insufflation space,” John says. As an example, Palliare believes that insufflators should have a layer of communication with other instruments in the OR and has embedded an API in the EVA15. This allows manufacturers of laparoscopic, endoscopic, and robotic systems to remotely control the insufflator.
Words of Wisdom
Palliare has always had the interests of people — both the patients and the clinicians delivering the care — at heart. John’s best advice to any medical technology or device developer is to be “needs-driven” instead of “technology-driven.”
He shares “We are excited to have recently obtained a U.S. patent for energy-activated smoke evacuation in continuous pressure insufflators. This is important because it means that CO2 waste is reduced, and less gas is needlessly evacuated from the surgical cavity. With most competitors, smoke evacuation is continuously activated for the entire procedure.”