Devices Draw Mixed Reviews in Tech-Con’s Shark Tank

Shanda H. Blackmon, MD, MPH explains the benefits of using the Blackmon-Mayo Buttressing Anastomotic Device to Shark Tank judges Saturday.

Shanda H. Blackmon, MD, MPH explains the benefits of using the Blackmon-Mayo Buttressing Anastomotic Device to Shark Tank judges Saturday.

Inventors tend to be optimists, perceiving their ideas as game-changers when the reality often is far different. Three physician-inventors of medical devices got a dose of reality Saturday by diving into STS/AATS Tech-Con’s Shark Tank, where peers judged their developments.

For two device developers, the news was good, while the third may be headed back to the drawing board, based on the comments of two judges and attendee polling results during “Shark Tank—Rapid-Fire Elevator Pitches of Revolutionary Thinking.” The “sharks” judging the devices were Patrick M. McCarthy, MD, of Chicago, and Rick Anderson, of PTV Healthcare Capital in Austin, Tex.

First up in pitching a development was Shanda H. Blackmon, MD, MPH, of the Mayo Clinic in Rochester, Minn., who presented the Blackmon-Mayo Buttressing Anastomotic Device, designed to prevent anastomotic leaks. It is used during an esophagectomy, after the stomach is pulled into the chest.

The device is a mandrel that is introduced through the mouth and goes down the esophagus, exiting the distal portion of esophagus. Inside the device is a self-expanding stent or mesh. The mandrel has LED lights that improve visibility and is moved into four positions where the stomach and esophagus are attached to the stent or mesh using T-fasteners.

“This allows coverage with overlap of the two structures you are joining, rather than creating an end-to-end anastomosis, so if there is a small leak, it is covered by an internal buttress,” Dr. Blackmon said.

In a texting poll, 43% of the audience said they were interested in investing, 33% said they would “possibly invest,” but would not be early investors, and 24% were not interested in investing. Dr. McCarthy called the device “novel” and said he was a possible investor, while Anderson said he was all in.

The second device pitched was the FlexDex, which translates a surgeon’s hand motion to a laparoscopic instrument tip during taxing minimally invasive surgery, such as a foregut procedure. It is a relatively inexpensive option to robotic surgery, said James D. Geiger, MD, of the University of Michigan in Ann Arbor, who is on the device development team.

FlexDex has a three-axis cuff gimbal that attaches to a surgeon’s wrist, isolating the hand from the arm. The device’s Virtual Center™ allows hand and wrist motions to precisely control the articulation of the instrument’s jaw.

“It is low-cost, simple, and easy to use, with a short learning curve,” Dr. Geiger said.

Both judges were interested in investing, and 73% of the audience agreed. Of the remaining attendees, 14% were possibly interested in investing, and 13% were not interested.

The final device presented was an expandable device for creating an easier, quicker, and more efficient anastomosis in aortic prosthetic substitution, presented by Stefano Nazari, MD, of Fondazione Alexis Carrel in Milan, Italy. Both judges and 41% of the audience were not interested in investing in the device. Also, 36% were interested, but not as early investors, and 23% were all in.

The session also featured two debates on the role that new technology plays in cardiothoracic surgery. A surgeon and a radiation oncologist debated whether thoracic surgeons need to do more than just operate as a treatment for early stage lung cancer, or if they should be involved at all in non-surgical treatment. The second debate explored whether new technology was the birth or the death of cardiac surgery.

Also during the session, John C. Laschinger, MD, a cardiothoracic surgeon who is a Medical Officer in the Food and Drug Administration’s Division of Cardiovascular Devices, discussed the agency’s device review process, while Dr. McCarthy reviewed missteps made by developers during the FDA’s review of the MitraClip device.

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