Every year, millions of people require organ biopsies to check whether the cells are cancerous or not. However, problems can arise when unintended bleeding occurs after taking the biopsy sample and removing the guide needlerequire additional procedures, open surgery, blood transfusions, and longer costs and recovery time. In very serious cases, it can lead to death.
Single Pass Inc. have developed the first and only disposable electrocautery device that could be extremely useful for preventing bleeding biopsies on solid organs, to quickly, easily and safely cauterize deep tissue through a guide needle to prevent bleeding.
Read more at singlepass.co
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In this episode we’re talking about a new medical device that has been developed and patented by a company called Single Pass, headquartered in Lake Forest, California. They’ve developed the first and only disposable electrocautery device that could be extremely useful for preventing bleeding after surgeons have carried out biopsies on solid organs, such as the liver and kidneys. Single Pass reports that their product can quickly, easily and safely cauterize deep tissue through a guide needle to prevent bleeding.
The technology was created by Dr. Peter Sunenshine and Dr. Kevin Hirsch, who began working on the problem around eight years ago. Peter and Kevin are both professors of Radiology at the University of Arizona School of Medicine. Peter works as an Interventional and Neurointerventional Radiologist and is the former Chief of Neurointerventional Radiology at Banner University Medical Center in Phoenix, Arizona. Kevin is an Interventional Radiologist at Banner University Medical Center and is the former Chairman of the Department of Radiology.
The Single Pass management team, working out of the ISO certified facility in California, has over 100 years of combined successful medical device development and commercial launch experience that includes several successful company exits.
We’ll talk about why this device has exciting potential in the medical world, how it works, and what a recent human trial is showing regarding its safety.
Every year, millions of people require organ biopsies. These are intrusive procedures, where doctors remove a small piece of the organ for further study. For example, if a tumor is found within a patient’s organ, a biopsy can be performed to check whether the cells are cancerous or not. Traditionally this is done with biopsy gun that is placed through a guide needle, a special type of hollow needle which is inserted into the organ with the guidance of X-ray, ultrasound, CT scan, or MRI scan.
However, problems can arise when unintended bleeding occurs after taking the biopsy sample and removing the guide needle. Some people may develop a small amount of bleeding around the organ, but others develop a more significant hemorrhage. A hemorrhage is uncontrolled bleeding from a ruptured blood vessel. The main issue is it’s difficult to predict who these problems might impact. Doctors can look at risk factors and monitor patients after operations, but it isn’t an exact science to know if and when someone is going to bleed after a biopsy.
Medical staff have some options available to them to reduce these risks and minimize any post biopsy complications. For example, they may choose to plug the site of the biopsy with hemostatic agents, which help to reduce bleeding. Sometimes a patient will need to be held in a recovery area with pressure bandages for several hours. It can also help to hold off on giving them any new treatments or medications during recovery time.
Despite these precautions, none are always effective at stopping hemorrhages with many studies demonstrating bleeding in over 5% of biopsies. Patients may require additional procedures, open surgery, blood transfusions, and longer costs and recovery time. In very serious cases, it can lead to death.
So, could Single Pass’s cauterization tool offer a better way to reduce post biopsy procedure complications?
The Single Pass device works through cauterization – the technical term for using electricity (or chemicals) to seal a wound by stopping bleeding. The device is able to control bleeding by heating the tip of the device probe via an electric current. This heated tip is applied directly to the biopsy site, coagulating the tissue and preventing bleeding. It might also sometimes be used to remove harmful tissues. Healing through electricity and heat might sound slightly odd at first, but cauterization is a fast and effective way to stop bleeding. It is the same way surgeons stop bleeding in open surgeries. It can also help reduce postoperative pain and scarring in patients.
What makes Single Pass unique, is its ability to get into the narrow biopsy channels to cauterize the tissue and prevent bleeding. This makes biopsies safer for patients by reducing the risk of the biopsy site hemorrhaging. It’s also simpler for doctors, as they can use larger guide needles and take bigger tissue samples instead of having to make multiple needle passes. In addition, this makes biopsy procedures safer for higher risk patients who are on anticoagulants, which make them more prone to bleeding.
This gives surgeons a high amount of control while also making biopsy procedures safer. Biopsies are important procedures, despite their risks, so it’s beneficial to be able to reduce anxiety on both patients and surgeons. From the patient’s perspective, a lower risk procedure with a shorter hospital stay will greatly reduce cost and stress. And for the surgeon, they can have peace of mind knowing there’s a lower risk of postoperative complications.
It’s a more cost-effective method too, as in this scenario there would be no need to apply hemostatic agents to the patient’s biopsy site. There’s also a reduced likelihood of further surgery or hospital time needed. Some cauterization tools need to involve unwieldy and expensive generators to operate. The Single Pass device is battery-powered, handheld, and disposable after use, making it a very convenient potential tool in a surgeon’s armory.
This is an exciting prospect, as to date Single Pass is the only electro-cautery device equipped with a probe that can fit into biopsy channels. But how safe is it? Next, we’ll dive into what the latest research data is telling us about Single Pass.
In the past, the Single Pass device has been through bench tests to determine its mechanical durability, as well as animal tests where blood loss was used as a key marker for safety. Results were positive so the focus has now shifted onto human applications and safety.
The most recent study, started in 2022 and finishing in early 2023, assessed the safety of the Single Pass electrocautery device on organs including liver, kidney, lung, breast, and other soft tissue biopsy procedures. Patients with known bleeding disorders were excluded from the study, along with anyone who had a medical condition that could interfere with results. In total, thirty one participants were analyzed.
Success was measured in five ways. Firstly blood loss measured at the biopsy site one hour after the operations. Secondly, researchers took into account the absence of observed bleeding after eight hours. Next, they recorded the absence of hematoma formation after 14 days post operation. After the 14 days, patients were also given a questionnaire asking about any other adverse effects they may have noticed. Finally, the total time spent in the hospital was recorded.
The results of the study were highly promising, with no serious adverse events recorded in any of the thirty one patients who took part. An interesting point to note is that study centers independently added ultrasound, video, and still images post procedure that showed no active bleeding or significant internal hematoma formation. The results were therefore even better than expected, as they weren’t required to do this and as the safety scope was not designed to capture these endpoints. So, after the success of an early human trial, what’s next for Single Pass?
For future developments, Dr Sunenshine and Dr. Hirsch have also said they want to find a way to detach the probe and keep the handle for reuse. They want to improve ergonomics for one handed use, and make the device available for traumatic hemorrhage occurring outside the hospital. However, the immediate focus will be on further studies to prove its safety in human patients.
The initial cases in North America were performed by Dr. David Tahour, Chief of Vascular and Interventional Radiology at Memorial Care Miller Children’s & Women’s Hospital Long Beach. Said Dr. Tahour, “The Kronos Single Pass device produced excellent clinical results. It offers a breakthrough solution for patients undergoing percutaneous biopsy who are at high risk of bleeding complications. Knowing such a solution exists places both patients and physicians at ease, and will create opportunities in the future for patients who might have otherwise not been a candidate for biopsy.”
The follow up to the afore-mentioned study will be an efficacy study, confirming and expanding upon the previous results. While evidence to date suggests that the protocol is safe, more investigation needs to be undertaken in the next steps to prove this. The further investigation will have a broader scope, but nonetheless, the results to date have been extremely promising and the researchers are highly optimistic about the future of Single Pass.
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