Transit Scientific Announces FDA Approval of Revolutionary XO Constrain Vascular Remodeling Platform

Transit Scientific stated that the XO Constrain platformCompared to the marketDiameter of 1.5 mm to 4 mm、Length: 6mm to 20mmThePTA, PTCA Balloon Compatible。

Doctors typically pull PTCA balloons when treating very small vessels in the distal peripheral vascular system and foot vasculature.XO Constrain can be used with off-the-shelf PTCA balloons., which promotes the controlled concentric expansion of these small vessel stenoses, bringing good news to a wide range of patients.

XO Constrain There isHelpful for expanding the engraved surface, in order to promote the cutting surfaceIliac, Femoral, Iliac-Femoral, Popliteal Artery, Infrapopliteal Artery, and Renal ArteryDilation and placement of the narrowed material;Used to treat congenital or synthetic arteriovenous dialysis fistula obstructive lesions.

Doctor of Medicine Richard Saxon Indicates:

XO Score is aAn integrated metal alloy outer sheath with up to 22 struts/grooves that can slide over an angioplasty balloon.

When the angioplasty balloon is inflated, The strut/groove inflates and rotates 90° together with the balloon, therebyTo crack, break, and dilate calcified atherosclerotic lesions and intimal hyperplasia lesions, and can be used for vascular pre-treatment in other therapeutic regimens.When the balloon deflatesTime，XO strut/groove rotates 90° back to the non-traumatic position, XO structure assists in re-wrapping the balloon for removal.

Currently XO ScoreReceived FDA 510(k) clearance in the United States in 2020 and CE certification in 2021., successfully used to dilate multiple fibrotic and calcified lesions in hemodialysis patients.

XO Score has two structural types, OTW and Rx, respectively, which are associated withTwo structural types of peripheral vascular balloons match each other.XO RX and XO OTW technologies are designed toReduce Shear Force, and by rotating 90 degrees in reverse during pressure reliefPromote the re-wrapping of the balloon。

XO Score Sheath - OTW Structure

XO Score Sheath - Rx Structure

Product Advantages of XO Score:

• Expandable to address calcification and intimal hyperplasia; treat resistant lesions at low pressure;

• Reduce shearing and promote PTA balloon refolding;

• Compatible with a wide range of standard PTA balloon sizes; (Outer Diameter 1.5-7mm, Length 20-200mm);

• Two structural designs, Rapid Exchange (Rx) and Over-the-Wire (OTW), meet the diverse needs of physicians.

# XO Cross

XO Cross For guidewire support, exchange, and contrast agent injection in peripheral vessels.

In complex endovascular surgeries,Microcatheters are commonly used to provide guidewire support., facilitating guidewire exchange, reaching distal anatomical structures, crossing lesions, performing therapeutic embolization, and injecting contrast agents.

A hydrophilic coating forms a lubricious layer on the catheter's exterior to enhance navigation and tracking through tortuous vessels and lesions.

The composition and characteristics of the XO Cross platform are as follows:

Metal Alloy Outer Frame——With 1:1 torque and excellent propulsion;

Non-tapered shaft(Tip to tail of the catheter's inner and outer diameter) - with dual support;

Ultra-thin Polymer Encapsulation——With a proprietary hydrophilic lubricious coating;

Cone-shaped radiopaque polymer tip——With ultra-small crossing profile, proprietary bonding technology, and excellent traceability;

In addition, it also hasSmall size, good pushability, trackability, shuttleability, and fatigue resistanceFeatures, can also be used for vascular imaging.

According to the company,XO Cross has also received FDA approval and EU CE certification., and has been safely and successfully used to treat challenging peripheral lesions (including but not limited to contralateral femoral artery access, antegrade femoral artery access, and retrograde pedal artery access for above-the-knee and below-the-knee chronic total occlusions).

# About Transit Scientific

The company was founded in 2016 and is dedicated to the design, development, and commercialization of medical devices.

Their product portfolio includesFDA Approved XO Cath, XO Score and XO Cross Platform, as well as those currently under development for peripheral and coronary artery procedures XO CS Contrain, and is supported by more than 20 issued and pending U.S. and global patents.