SPINR High-Performance Controllers

INDICATIONS FOR USE: The SPINR are used to maneuver guide wires in the 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 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.”

Distal Access - Pilot Access and Biopsy

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.”

Distal Access - SHAVR

ABOUT DISTAL ACCESS

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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

Distal Access - SPINR

PILOT Access & Biopsy ™

Distal Access - Pilot Access and Biopsy

SHAVR

Distal Access - SHAVR

Unmet Need - Distal Access Medical Devices

Unmet Need - Distal Access Medical Devices

Unmet Need - Distal Access Medical Devices

Unmet Need - Distal Access Medical Devices

OUR TEAM

SHAWN FOJTIK
CEO
Park City, Utah USA

LAWRENCE KRONICK
Director of International Sales
Hallandale Beach, Florida USA

TIM NIEMAN
Engineering
Salt Lake City, UT USA

ERIK LIDDIARD
Engineering
Salt Lake City, UT USA

THIAGO HASSEGAWA
Brazil Country Manager
Sao Paulo, Brazil

DIETER HOEVEL
European Manager
Munich, Germany

M.A. SUDHEER
India Country Manager
Bengaluru, India

ALAN YANG
China Manager

SHINYA MIIKE
Japan Manager
Tokyo, Japan

SAM KANAZAWA
Japan Manager
Tokyo Japan

CAROLINA GREGORIO
Latin America Sales Manager &
Global Sales Support
Hallandale Beach, Florida USA

CARMEN AGUILERA
Order Administrator & Trade Shows
Hallandale Beach, Florida USA

Shawn Fojtik
CEO
Park City, Utah USA

Shawn Fojtik has (100+) combined issued and pending patents on angiographic, angioplasty, biopsy, embolic, imaging, electrophysiology, tissue resection, thrombectomy, women’s health, and other devices. His background includes sales, marketing, product development, and general management experience at General Electric Medical Systems, Boston Scientific, Black & Decker, and start-ups. Shawn has a Bachelor’s Degree from the University of Illinois in Champaign, Illinois; a Master’s Degree from Harvard University in Cambridge, Massachusetts; and is an Adjunct Assistant Professor of Surgery (non-clinical educator) at the University of Utah in Salt Lake City, Utah.

Lawrence Kronick
Director of International Sales
Hallandale Beach, Florida USA

Lawrence Kronick has over 35-years of operational experience in cardiovascular, interventional radiology, electrophysiology, general surgery, and imaging sales, marketing, and business development. He is the founder of BAC Inc., a consulting company with teams in Miami, Sao Paulo, Tokyo, Hong Kong, Bengaluru, Munich, and Beijing assisting medical device and equipment companies expand and develop global sales distribution. Mr. Kronick speaks Mandarin and English.

Tim Nieman
Engineering
Salt Lake City, UT USA

Tim Nieman holds a BS in Bioengineering from Arizona State University and has more than two decades of experience in medical device development. His experience includes roles with CR Bard, Worldheart, and Edwards Lifesciences. His accomplishments include device commercialization for cardiovascular stents, catheters, wires, LVADs, and ablation devices. He has 7 issued or pending patents.

Erik Liddiard
Engineering
Salt Lake City, UT USA

Erik Liddiard, holds a BS in Bioengineering and an MS in Mechanical Engineering from University of Utah with over 12 years’ experience in medical devices and pharma. Mr. Liddiard has led the development of more than 5 devices and has contributed to Control Medical’s and Distal Access's intellectual property.

Carolina Gregorio
Latin America Sales Manager &
Global Sales Support
Hallandale Beach, Florida USA

Carolina Gregorio has 20-years’ experience in international trade, marketing, and logistics with BAC Inc. and ICI Paints (UK). Carolina received a graduate degree in Corporate Logistics Management from the Argentine Business University. Ms. Vance is fluent in Spanish, English, and Portuguese.

Thiago Hassegawa
Brazil Country Manager
Sao Paulo, Brazil

Thiago Hassegawa is native to Brazil and he received his Electronic Engineering degree from Universidad Federal De Itajuba of Sao Paulo State University. Mr. Hassegawa spent over 6 years in service and sales at Phillips and CMS Produtos Médicos where he serviced and sold both capital equipment and disposable medical products. Thiago provides valuable in country experience and knowledge and speaks both English and Portuguese.

M.A. Sudheer
India Country Manager
Bengaluru, India

M.A. Sudheer has 13 years of Healthcare industry experience in India. His professional career started as a sales executive for Aloka Ultrasound in Northern India and subsequently grew into a Managerial position. Following Aloka, Sudheer was responsible for marketing NIC products (Mortara and Del Mar Reynolds) and critical care products in different positions with reputed companies before moving to Spacelabs Healthcare as a Sales & Marketing Manager.

Dieter Hoevel
European Manager
Munich, Germany

Dieter Hoevel is based in Germany and has over 30 year of experience in the medical device industry. He has been involved in successful medical device start-up companies, such as Micrus, Acandis and Neoventa. Previously he worked with Boston Scientific Corporation, Cordis and B. Braun in various sales, marketing, and general management roles. During this time, he worked in EMEA in senior positions including Vice-President Sales & Marketing for Straub Medical. Mr. Hoevel is fluent in German, English, French and Dutch.

Alan Yang
China Manager

Alan Yang graduated from the China Civil Aviation College with a degree in engineering and has over twenty years of medical equipment sales experience in China. Alan specializes in the development and implementation of sales and marketing programs for our client’s product portfolios in the China market. Since 1985, Alan has introduced a variety of advanced medical technologies to China including products from Cook, Medtronic, Bausch & Lomb, Stryker, Picker International and Philips. Mr. Yang is fluent in both English and Mandarin Chinese.

Shinya Miike
Japan Manager
Tokyo, Japan

Shinya has over 25-years of experience in the medical device business in Japan particularly in the field of endoscopic medicine. He has developed and marketed new types of endoscopes and invested in several Venture companies who have developed various new medical devices He has developed strategies and tactics for penetrating Japanese medical markets and established new surgical techniques. Shinya is also a pioneer in the ultra-thin endoscopic field (under 1mm outer diameter) for ophthalmology, breast surgery and Cardiology. Shinya received 1st Prize at the Tokyo Technology Venture Awards in 2004.

Sam Kanazawa
Japan Manager
Tokyo Japan

Osamu (Sam) Kanazawa resided in the USA for 7 years and has an undergraduate degree from Franklin and Marshall College and an MBA from Bond University in Australia. He has over thirty years of medical marketing experience in Japan. Sam began his career with American Hospital Supply and has had positions in many large international companies, including Beckman Instruments, Boston Scientific, Jomed, and St. Jude Medical. Sam also worked for a number of Japanese companies including a thin fiber endoscope company called FiberTech.

Carmen Aguilera
Order Administrator & Trade Shows
Hallandale Beach, Florida USA

Carmen Aguilera manages global order administration, press, and trade show activities.