CryoPen GY2 Cervical Attachment

Target SDGs

Market Suggested Retail Price

$4,656.98

Target Users (Target Impact Group)

Small and Medium-sized Enterprises, Public Sector Agencies

Distributors / Implementing Organizations

Distributed by CryoPen, Inc.

Competitive Landscape

Direct competitors include Cryo Super Model AA3, Super Deluxe Silencer Gun Model: CRYO-004, and Cryo Super Model AA2.

Regions

Africa, North America

Manufacturing/Building Method

Mass produced in the U.S.A. by IDM Tech, LLC for CryoPen, Inc.

Intellectural Property Type

Patent

User Provision Model

The user can order the CryoPen by contacting CryoPen via phone or online form.

Distributions to Date Status

Unknown

Design Specifications

Each CryoPen reaches the optimal surgical temperature of -105° Celsius without cryogenic gases or liquids. CryoPen re-usable tips are available in 3mm, 10mm, 19mm, and 24mm sizes.

More information can be found in the CryoPen GY2 Cervical Attachment Brochure.

Product Schematics

Technical Support

Regular user maintenance is encouraged in the user manual.

If there is a suspected problem with the device, call CryoPen at 1-877-246- 3955.

Purchase of the device includes a limited one year warranty. CryoPen, Inc. agrees only to correct or replace, at its option, any CryoPen system that shall be returned to CryoPen, Inc. Transportation of the unit will be prepaid by the original owner, after being placed into service by the original owner, provided that CryoPen, Inc. is satisfied that the equipment was originally defective in either workmanship or materials. Normal wear and tear is not warranted.

Replacement Components

To order additional supplies, the user should contact CryoPen, Inc. at 1-877-246-3955

Lifecycle

Battery life for the CryoPen is estimated at 5 years and at that point should be returned to CryoPen for a replacement battery.

Manufacturer Specified Performance Parameters

CryoPen, Inc. is a medical device company dedicated to the research and development of innovative, technologically advanced medical products and applications that will enhance the quality of our lives.

The LMIC-adapted CryoPen overcomes barriers to standard gas-based cryotherapy by eliminating dependency on gas, increasing portability, and ensuring consistent freeze temperatures. Further testing and evaluation of the adapted CryoPen will be pursued.

Vetted Performance Status

Performance: In 80% of the cases in the pilot study, the adapted CryoPen achieved the target depth of necrosis 3.5 mm established in the pathology review.

Safety

WARNINGS:

- If re-usable tip gets stuck on skin, remove the Pen Core from tip by gently rotating counter clockwise to unlock it and allow to thaw.

- This device should be used with caution on patients with diabetes, peripheral vascular disease or cold intolerance problems.

- Do not perform cryosurgery using GYN attachment when ECCa is positive for CINb . - - Gynecologic cryosurgery is not recommended for patients who are pregnant.

- Do not perform Gynecologic cryosurgery on lesions not fully visible or extending beyond the range of the cryotherapy probe.

- Do not use the electrical charging unit near or in water. Doing so may cause electrical shock resulting in serious injury or death to the user.

- Do not use an extension cord. Use of extension cords may present potential fire hazards.

- Explosion hazard! Do not use in presence of flammable anesthetics. Unit contains 1oz. of an ethanol based proprietary solution.

- Ethanol is poisonous! May be fatal if swallowed and harmful if inhaled or absorbed through skin. Please refer to Material Safety Data Sheet regarding the ethanol based reservoir solution.

- Reservoir solution contains alcohol (ethanol). Avoid skin contact with the reservoir solution on persons taking the medication ANTABUSE®.

- The CryoPen Pen Cores are extremely cold. Accidental contact with core may result in frostbite. Touch only the green plastic handle when core is at cryogenic temperatures.

- Do not use the CryoPen® Pen Core without a sterile tip. Doing so will expose your patients to non-sterile conditions and may cause cross patient contamination. Pen Core could also become stuck on patient’s skin thereby causing injury to the patient.

- Do not use E-beam, Gamma radiation, or Ethylene oxide to sterilize tips for Gynecologic or General Cryosurgery use.

PRECAUTIONS:

- Never leave the chilling wells open. Doing so will render your unit inoperable. Always replace a cold pen core with a warm pen core that has been wiped dry and dipped in the CryoPen Reservoir Solution, or use the black non-functional core to replace a cold pen core.

- Use of CryoPen® on lesions with hair, may cause patient to lose hair.

- Use of CryoPen® on lesions in areas where pigment is critical to patient, patient should be made aware that change in pigment may result.

- Federal Law restricts this device to sale, distribution and use by or on the order of a physician.

- Handle the pen cores with great care. Dropped pen cores will be damaged and may become trapped in the pen tips.

- Cold pen cores should be placed in a tip or defrost wells immediately to avoid damage.

- Clean CryoPens® Pen Cores by wiping down with soap and water or with standard solutions such as isopropyl alcohol. Clean only when they have reached room temperature. Do not submerge the Pen Cores. Doing so will render them inoperable.

- Should CryoPen® GY2 tips become attached to the patient, remove the GY2 pen core from the GY2 handle and insert a room temperature pen core into the handle, allow to thaw, and then remove the tip from the treatment area.

- GYN attachment handle contains two, AA alkaline batteries. Dispose of batteries according to applicable regional and national laws. Upon failure, batteries may be replaced with AA, alkaline batteries. Use of rechargeable cells is NOT recommended.

- Discontinue use of Aluminum reusable tip in the presence of discoloration or tarnishing and alert CryoPen Technical Support.

- Please refer to current clinical practice guidelines to determine which patients with cervical cancer precursors are candidates for cryotherapy.

Always properly clean device according to manufacturer instructions after each use.

Other safety precautions can be found at the material datasheet.

Complementary Technical Systems

The CryoPen basic dermatological package, rubber gloves, a plastic apron, eye protection, and mask

Academic Research and References

Compliance with regulations

FDA certified.

Evaluation methods

Global potential users of the adapted CryoPen participated in discussion groups and a card sorting activity to rank 7 features of the adapted CryoPen: cost, durability, efficacy and safety, maintenance, no need for electricity, patient throughput, and portability. Mean and median rankings, overall rankings, and summary rankings by discussion group were generated.

A pathology review of CIN grade 3 cases (N=107) to determine target depth of necrosis needed to achieve high efficacy; and a pilot study (N=5) investigating depth of necrosis achieved with the adapted device to assess efficacy.

Other Information

Press release

Dispose in accordance with all local, federal, and state regulations.