Feature | Heart Valve Technology | July 28, 2015

Boston Scientific Announces CE Mark and FDA Clearance for Safari2 Pre-Shaped Guidewire

Guidewire designed specifically for TAVI/R now sized for smaller ventricles


July 28, 2015 — Boston Scientific announced CE Mark and U.S. Food and Drug Administration (FDA) clearance for the Safari2 Pre-Shaped Guidewire. Safari2 is an enhanced version of the  Safari Guidewire, intended to facilitate the introduction and placement of interventional devices within the heart, including those used with transcatheter aortic valve implantation or replacement procedures (TAVI/R). The Safari2 Guidewire is compatible for use with all TAVI/R devices.

The device provides a streamlined delivery with enhanced wire predictability and shape retention for interventional devices within the heart. Additionally, the Safari2 product line offers the widest guidewire choice with three curve sizes, including a new extra small curve designed for procedures involving patients with smaller ventricles, a current unmet need in this population.

Having a pre-shaped, universal TAVR guidewire helps physicians deliver the replacement valve with reliability and consistency,” said Wesley Pederson, M.D., director of valve and structural heart disease at the Minneapolis Heart Institute. “This is a wonderful development to have a smaller curve size so that we can offer this less invasive treatment option to a broader range of patients because valvular disease can have a devastating impact on patient survival and quality of life.”

The Safari2 Guidewire complements the Boston Scientific Lotus Valve System, designed to give physicians more control throughout the TAVI/R procedure.

For more information: www.bostonscientific.com


Related Content

News | Heart Valve Technology

January 4, 2024 — Findings from a published case series research letter by the Henry Ford Health Structural Heart ...

Home January 04, 2024
Home
News | Heart Valve Technology

December 22, 2023 — TRiCares SAS (“TRiCares”), a privately held pioneer in the field of minimally invasive treatment of ...

Home December 22, 2023
Home
News | Heart Valve Technology

December 18, 2023 — Death rates related to infective endocarditis declined in most adults across the U.S. within the ...

Home December 18, 2023
Home
News | Heart Valve Technology

December 12, 2023 — Patients who received the anticoagulant drug warfarin after bioprosthetic aortic valve replacement ...

Home December 12, 2023
Home
News | Heart Valve Technology

November 20, 2023 — Abbott announced new late-breaking data that show advanced heart failure patients living with its ...

Home November 20, 2023
Home
News | Heart Valve Technology

October 24, 2023 — Abiomed, part of Johnson & Johnson MedTech[1], announced that novel data from seven research studies ...

Home October 24, 2023
Home
News | Heart Valve Technology

October 17, 2023 — The Patel Children's Heart Institute at St. Joseph's Children's Hospital achieved a milestone ...

Home October 17, 2023
Home
News | Heart Valve Technology

August 2, 2023 — Foldax, Inc., a leader in the development of innovative, polymer heart valves, today announced that the ...

Home August 02, 2023
Home
News | Heart Valve Technology

July 31, 2023 — Today, the U.S. Food and Drug Administration (FDA) is providing an update to the February 27, 2023 ...

Home July 31, 2023
Home
Subscribe Now