How Minimally Invasive Surgical Products Fit into the new OR

an individual checking a medical device with someone laying on a hospital bed in the background | Product Creation Studio

The operating room has changed. Globally, hybrid operating rooms are becoming popular alternatives to traditional surgical theaters. These spaces are advanced arenas that combine a standard operating room with an image-guided interventional suite. The combination allows for highly complex, advanced surgical procedures and minimally invasive surgical equipment. Further, multi-disciplinary teams are combined to form a group of clinicians prepared to meet the complex needs of patients.

The flexible design and multi-disciplinary resources enable more procedures to be performed safely and efficiently in Hybrid ORs, including cardiac procedures that were previously performed in cath labs.

The rapid pace of innovation in these hybrid ORs includes a surge of minimally invasive treatments that can ensure faster, more effective surgical procedures. Minimally invasive surgical technologies and devices provide design features that make their products easy to move and place during surgery from small incision points using the body’s existing pathways. Because of the small points of access and deployment methods, these minimally invasive surgical devices offer faster surgical times and quicker recovery for patients.  

These days, both large and small players are leading the way with minimally invasive surgical products that can be used in Hybrid ORs. Some offer innovative uses of drug delivery, ultrasound, and unique shapes to improve surgical outcomes. Further, iterative improvements are emphasizing the stability of the surgical tools and greater accuracy of placement. We’ve identified several products that are making waves in the minimally invasive surgical equipment field.  

Cardiovalve received FDA’s Breakthrough Device Designation in March for its Transcatheter Tricuspid Valve Replacement System. The system is designed to treat mitral and tricuspid regurgitation by replacing the native valves via a transfemoral approach. Using a transfemoral procedure allows surgeons to offer a minimally-invasive alternative to open-heart surgery or transapical delivery with mini-thoracotomy access.

Israel-based Cardiovalve says its system provides significant benefits, including a short profile for minimal protrusion to the left or right ventricle that minimizes interference with the cardiac blood flow. It is also designed with an enhanced seal to prevent paravalvular leaks. 

Initial clinical results demonstrate high procedural success, and the first patients have had sustained clinical benefits for more than two years. 

Last year, Spiration, a subsidiary of Olympus Respiratory America, announced the first endobronchial valve treatment of severe emphysema using the FDA-approved Spiration Valve System. The Spiration Valve is an umbrella-shaped device that is placed in targeted airways of the lung during a short bronchoscopic procedure. Once in place, the SVS is designed to redirect air from diseased parts of the lung to healthier parts, allowing the healthier lung tissue to expand and function more effectively. 

In March, Abbott received the EU CE Mark for its FlexNav delivery system for the company’s Portico transcatheter aortic valve. Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for patients diagnosed with aortic stenosis, a condition that restricts blood flow through the valve. TAVR offers a valuable alternative for patients at high risk who may not be candidates for open-heart surgery. Abbott emphasized the delivery system, providing greater stability, predictability, and placement accuracy for the TAVR procedure. 

EKOS Acoustic Pulse Thrombolysis procedure is a technique that dissolves blood clots in the vascular system via a catheter. The EKOS procedure is minimally invasive and uses lower doses of medicine. It treats conditions including pulmonary embolism, deep vein thrombosis (DVT), and peripheral arterial occlusion. During catheter-assisted thrombolysis treatment, a catheter is guided through blood vessels to the location of the blood clot.  

The catheter delivers special, clot-dissolving medicine called thrombolytics to help dissolve the clot. EKOS also delivers ultrasound energy to dislodge and loosen the clot mechanically. The EKOS procedure increases thrombus (blood clot) removal and clinical improvement compared to either standard catheter-directed thrombolysis (CDT) or thrombectomy.  

The future of the OR

The hybrid operating room market was valued at $744 million in 2018 and is estimated to reach $1,804 million by 2026, according to ReportLinker. As operating rooms evolve, surgeons will look for even more accurate minimally invasive surgical devices and technology that emphasizes proving clinical outcomes through technology innovations as well as improvements in surgical tool deployment.