Medtronic’s Concerto Versa Detachable Coil Makes its Clinical Debut

Medtronic today announced the first successful clinical use of the Concerto Versa coil, a device used for arterial and venous embolization in the peripheral vasculature to help control bleeding or treat vascular disease. The first procedures were performed by Dr. Rahul Patel, an interventional radiologist at The Mount Sinai Hospital (New York, N.Y.) and Dr. Gloria Salazar, an interventional radiologist with UNC Hospitals in Chapel Hill, N.C.

Specifically designed for large vessels, the Concerto Versa coil is a large volume coil compatible with many catheters that enables clinicians to maintain optimal control. The Concerto Versa coil delivers more compatibility, volume, and control for peripheral embolization while maintaining the small coil capabilities of the company’s Concerto helix and 3D coils.

“The ability to reposition the coil easily adds a level of control that’s very helpful,” Dr. Patel stated.

“Whenever you’re dealing with tortuous anatomy, dual catheter compatibility becomes critical. If you can’t reach the target, you can’t treat it. Once you are in position, you need stability—that’s where smooth and controlled deployment really matters,” Dr. Salazar added.

Concerto Versa coil product features include: 

• Unparalleled catheter compatibility to let physicians address complex anatomies without sacrificing speed or precision.¹
• The flexibility to be used with a diagnostic catheter or microcatheter.
• More efficient procedure time with 34% shorter catheterization time and 35% less radiation exposure during catheterization.^†,1
• Designed with thick diameters and longer lengths to reduce the number of coils needed per procedure.^‡,1
• A multi-sphere shape (3-14mm) designed to position and pack.
• A sphere shape (16-32mm) designed to frame or fill.
• 50% less necessary inventory per diameter.^§,1
• Combination of high-volume capacity with small-coil control throughout procedures.
• Softness for trackability through the most tortuous anatomy.¹
• Detachment system with a 99.7% reliability.¹
• Fibers that increase thrombogenicity compared to bare metal coils.²

“The Concerto Versa coil simplifies physician workflow by combining the benefits of a large volume coil with the ability to deliver through both microcatheters and diagnostic catheters. Embolization is an exciting market for Medtronic,  and we are investing to play a leadership role in driving new innovations for this therapy in the coming years,” said David Moeller, senior vice president/president of Peripheral Vascular Health, which is part of Medtronic’s Cardiovascular portfolio.

The Concerto Versa coil has been cleared by the U.S. Food and Drug Administration and is currently available in the United States. 

Headquartered in Galway, Ireland, Medtronic is the world’s largest global healthcare technology company that aims to alleviate pain, restore health, and extend life. It global team encompasses more than 95,000 workers across more than 150 countries. The company’s technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, and patient monitoring systems, among others. Medtronic delivers technologies that transform the lives of two people every second, every hour, every day.

* Dr. Patel and Dr. Salazar are paid consultants for Medtronic.
† Compared to other microcatheter compatible coils when a 4F diagnostic catheter (ID <=0.042″) can be used to reach the embolization target. ​
‡ Compared to any other microcatheter compatible coil commercially available​
^§ Compared to AZUR CX 35 and Interlock-35 for equivalent treatment options.​

References
¹ Data on file at Medtronic D01346573_A Design characterization report Concerto Versa 2.0. Bench and animal testing may not be indicative of clinical performance.​
² Girdhar G, Read M, Sohn J, Shah C, Shrivastava S. In-vitro thrombogenicity assessment of polymer filament modified and native platinum embolic coils. J Neurol Sci. April 15, 2014;339(1-2):97-101.​
³ Data on file at Medtronic D01448665_A Design characterization report Concerto Versa Coil Volume and Shelf Inventory Report.