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

A Sapien 3 TAVR valve in position as seen under GE Assist guidance on angiography. Study Finds Sustained Benefit for TAVR vs. SAVR at One Year. #TCT2019 #TCT19

A Sapien 3 TAVR valve in position as seen under GE Assist guidance on angiography.

News | Heart Valve Technology | October 04, 2019
October 4, 2019 – A new analysis of the PARTNER 3 Trial data found a modest, but significant, improvement in one-year
Five-year results from the PARTNER 2A Trial found patients with severe aortic stenosis (AS) and intermediate surgical risk who underwent Sapien 3 transcatheter aortic valve replacement (TAVR) had similar rates of death and disabling stroke compared to those who had surgical aortic valve replacement (SAVR). However, TAVR using a transthoracic approach had poorer outcomes compared to SAVR. #TCT2019
News | Heart Valve Technology | October 03, 2019
October 3, 2019 – Five-year results from the PARTNER 2A Trial found patients with severe aortic stenosis (AS) and int
The Boston Scientiofic Acurate Neo TAVR valve did not meet non-inferiority to the Sapien 3 valve in patients with severe aortic stenosis. #TAVR #TCT2019
News | Heart Valve Technology | October 02, 2019
October 2, 2019 – The first randomized trial to compare the safety and efficacy of the new Boston Scientific Acurate
The Portico FDA investigational device exemption (IDE) study found that 30-day safety and one-year effectiveness outcomes of a novel self-expanding transcatheter aortic valve replacement (TAVR) system for patients with severe aortic stenosis (AS) at high or extreme-risk for surgery was noninferior to contemporary FDA-approved TAVR systems. #TAVR #TCT2019
News | Heart Valve Technology | October 02, 2019
October 2, 2019 – The Abbott Portico FDA investigational device exemption (IDE) study found that 30-day safety and on
Medtronic Launches Evolut Pro+ TAVR System
Technology | Heart Valve Technology | September 24, 2019
Medtronic announced U.S. Food and Drug Administration (FDA) approval and U.S. launch of the Evolut Pro+ transcatheter...
Reducing Secondary Mitral Regurgitation in Heart Failure Does Not Improve Two-year Outcomes
News | Heart Valve Technology | September 11, 2019
Percutaneous reduction of secondary mitral regurgitation in patients with heart failure does not lower death and...
Abbott Launches Pivotal Trial of TriClip Tricuspid Valve Repair System
News | Heart Valve Technology | September 05, 2019
Abbott announced the launch of the company's TRILUMINATE Pivotal trial evaluating the safety and effectiveness of its...
An illustration of the BASILICA procedure showing the leaflet of the original bioprosthetic valve sliced open to allow coronary blood flow after implantation of a TAVR valve. The new TAVR valve can push the leaflets of the bioprosthetic valve upwards, blocking the coronary arteries. During the BASILICA procedure, a catheter directs an electrified guidewire through the base of the left aortic cusp into a snare in the left ventricular outflow tract (LVOT). After snare retrieval, the mid-shaft of the guidewire

An illustration of the BASILICA procedure showing the leaflet of the original bioprosthetic valve sliced open to allow coronary blood flow after implantation of a TAVR valve. The new TAVR valve can push the leaflets of the bioprosthetic valve upwards, blocking the coronary arteries. During the BASILICA procedure, a catheter directs an electrified guidewire through the base of the left aortic cusp into a snare in the left ventricular outflow tract (LVOT). After snare retrieval, the mid-shaft of the guidewire is electrified to lacerate the leaflet, and the the leaflet splays after TAVR permitting coronary flow.

Feature | Heart Valve Technology | August 27, 2019
A novel technique has proven successful in preventing coronary artery obstruction during transcatheter aortic valve r
Overlay Init