INDICATIONS FOR USE: The SPINR are used to maneuver guide wires in the coronary and peripheral vasculature. SPINRs are not intended for use in the neurovasculature. SPINR devices are “tools” not “treatments.”
Accessing distal anatomy, navigating tortuous vessels, crossing lesions, and working through blockages with guidewires can be challenging.
These challenges vary based on the vessel type, size, location, and disease morphology. Some procedures benefit from slow clockwise and counterclockwise guidewire control, other cases need high-torque guidewire maneuvering.
Basic torque devices are easy-to-use, but they provide limited in torque, predictability, speed, control, and overall performance. Electromechanical may improve performance for certain procedures, but they are complex, expensive, and often lack tactile feel.
SPINR™ High-Performance Controllers deliver high-torque with predictable clockwise and counterclockwise control.
No motors, electricity, or capital equipment.
Clinicians control the SPINR’s actuation with their hand based on what they see and feel during the procedure.
Squeezing the front handle rotates the guidewire clockwise 5X, releasing the front handle rotates the guidewire counterclockwise 5X. Clinicians control rotational speed and advancement or withdraw throughout the procedure. Physicians may also use their high-torque 0.014”-0.035” guidewire of choice for the situation.
· Predictable clockwise & counterclockwise rotations
· 5X clockwise & counterclockwise rotations per squeeze
· Improved torque
· Variable speed high-performance control
· 0.014” – 0.035” guidewire compatibility
· Peripheral vasculature
PILOT ACCESS & BIOPSY ™
Bone access and percutaneous biopsy may be performed with a variety of devices, systems, and techniques including basic manual devices and electromechanical drill-like systems.
Basic manual devices are cost-effective and easy-to-use, but often lack speed, power, control, and effectiveness. Electromechanical systems may improve speed and power for certain cases, but may require costly capital equipment, service contracts, complex set-up, and expensive disposables. Some electromechanical systems reduce physician tactile “feel” for the procedure and may introduce new risks that outweigh their benefit.
The PILOT is a single-use, non-powered, hand-held, and hand-manipulated tool designed to combine the benefits of basic manual devices and electromechanically powered systems.
Clinicians squeeze and release the handle with their fingers to actuate. Improved control means physicians can perform percutaneous biopsy and/or bone access based on what they see and feel during the procedure.
INDICATIONS FOR USE: The PILOT Access & Biopsy 11ga 10cm device is a non-powered, hand-held, and hand-manipulated manual surgical instrument designed for bone access and percutaneous biopsy. PILOT devices are “tools” not “treatments.”
HAPTIX ™
Certain bone access and bone biopsy procedures involve drilling into hard cortical bone, softer cancellous bone, and/or into intramedullary space.
HAPTIX is a multi-use, rechargeable, high-torque electric tool with sensor to help clinicians feel the difference between hard bone and soft bone/intramedullary space.
The sensor is always-on, no extra buttons to press or enable, and it helps sense changes in bone density so clinicians can make instant decisions based on what they sense.
HAPTIX also includes a novel auto-ratchet that allows users drill with the electric motor or manually ratchet a needle, drill bit, k-wire, or other.
SHAVR
Tissue and/or pathology resection may be performed with a variety of surgical instruments, systems, and techniques including basic manual devices and electromechanical systems.
Basic manual devices are cost-effective and easy-to-use, but often lack speed, power, control, and effectiveness. Electromechanical systems may improve speed and power for certain cases, but require costly capital equipment, service contracts, complex set-up, and expensive disposables. Some electromechanical systems reduce physician tactile “feel” for the procedure and may introduce new risks that outweigh their benefit.
The SHAVR is a single-use, non-powered, hand-held, and hand-manipulated tool designed to combine the benefits of basic manual devices and electromechanically powered systems.
Clinicians squeeze and release the handle with their fingers to actuate cutting speed and control. Aspiration may be provided by wall suction and/or an aspiration pump. Improved control means physicians can perform surgical resection based on what they see and feel during the procedure.
INDICATIONS FOR USE: The Shavr is a non-powered, hand-held, and hand-manipulated manual surgical instrument for tissue resection. Shavr devices are “tools” not “treatments.”
ABOUT DISTAL ACCESS
DISTAL ACCESS
Distal Access designs and develops medical devices to improve patient care including:
Medical Device Controllers
Tissue Resectors, Macerators & Cleaners
Access & Biopsy Devices
Medical devices can help clinicians improve patient care. New technology is often developed with expensive complex electromechanical drive systems that increase speed & power, but often are cost-prohibited and result in less physician tactile feel for the procedure.
Distal Access’s platform is designed to improve performance and maintain physician feel and control for procedure with cost-effective devices. The SPINR driver is a core innovation at Distal Access that allow clinicians to increase torque, speed, power, and/or control with the power of the clinician’s hand.
WATCH IT IN ACTION
SPINR
PILOT Access & Biopsy ™
SHAVR
1920 E. Hallandale Beach Blvd, Ste 905
Hallandale, Florida 33009 USA
(954) 534-9345 | Email Us