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Spryng for Canine

This treatment applies to the following species:
Company: PetVivo

with OsteoCushion™ Technology

Instructions for use

Veterinary medical device for use in dogs.

Veterinary Use Only

Federal law restricts this device to use by or on the order of a licensed veterinarian.

1. Product Description

Spryng is an intra-articular injection that is designed to prevent the occurrence and re-occurrence of joint pain from loss of cartilage or tissue-bone mechanical malfunction by augmenting and reinforcing cartilage to assist in the normalization of joint function. The Spryng gel-particles act as a micro-cushion mass of material that integrate into the synovial fluid and surrounding space to provide a soft, lubricous, elastic cushion. The synovial fluid is absorbed by and passes through the gel-particles, which are insoluble and will slowly absorb into the surrounding tissues within the joint.

Spryng is composed of a protein-carbohydrate matrix made from purified, natural materials. Each Spryng micro-cushion is a purified composition of two proteins (collagen, elastin) and a carbohydrate (heparin glycan) that self-assemble to form a sterile, insoluble, and pliable matrix using a proprietary, patented process. This process naturally forms a strong, sterile hydrated biomaterial that mimics natural cartilage.

1.1 How Supplied

Spryng material is sterile and supplied in aseptically filled, luer lock syringes. Syringes contain 2 cc of Spryng. Each package contains one (1) syringe of Spryng (needle not included).

Figure 1.

1.2 Storage

Spryng particles are recommended to be kept at approximately 40°-90°F. Use of Spryng particles is recommended within 26 months of the manufacture date on the package.

2. Intended Use and Indications for Use

Spryng particles for intra-articular injection are intended for cartilage reinforcement and/or augmentation. It is indicated to aid in the management of joint pain from loss of cartilage or tissue-bone mechanical malfunction caused by joint dysfunction not associated with infection (e.g., lameness, osteoarthritis, degenerative joint disease). Spryng matrices restore proper joint mechanics by adding natural, viscosolid matrices to the joint’s synovial fluid.

For use in dogs to maintain and/or improve articulation.

3. Contraindications

Spryng is contraindicated in the following conditions:

● If there is an infection.

● If significant inflammation is present in the joint (i.e. swollen, tenderness, erythema).

Note: Spryng particles can be injected if there is no or mild inflammation in the joint or if the inflammation has been effectively treated with an anti-inflammatory agent. If inflammation exists, prior effective treatment with anti-inflammatory agents is recommended.

4. Warnings

Spryng particles must not be injected into blood vessels. Injection of Spryng particles into blood vessels can interfere with local circulation, resulting in vessel laceration, occlusion, infarction, embolic phenomena, and/or abscess at injection site.

Not for use in humans. Keep this device out of the reach of children.

5. Precautions

Using drugs that reduce coagulation (e.g., NSAIDs) may cause increased bruising or bleeding at the injection site. Injection should be performed only by a licensed veterinarian skilled in the delivery of intra-articular (IA) injections.

6. Directions for Use

Spryng material is sterilized and aseptically filled in syringes containing 2 cc of material. It is intended for single-use, intra-articular injection (Figure 1). Use clinical judgement pertaining to volume needed. The amount of Spryng particles injected should represent an appropriate volume as determined by the veterinarian.

Preparation for use

● The injection site should be thoroughly disinfected.

● Follow aseptic techniques.

● Animal restraint and sedation is recommended.

● The injection technique, location, amount of synovial fluid removal, depth of injection, needle type, and the administered quantity of Spryng, may vary based on veterinarian clinical judgment and the joint selected.

● Spryng particles should be administered using a sterile needle (e.g., 18-23G). The needle should be inserted based on the veterinarian’s assessment of the needle tip location.

● Settling of Spryng particles in the buffer solution during storage is normal; injection in the settled state will not impact its efficacy. Shaking to disperse particles may be performed.

● Inject Spryng particles by applying even pressure on the plunger rod.

● Route of administration is via intra-articular injection. Multiple joints may be injected as a part of the same treatment.

● Spryng is recommended for repeat administration depending on the veterinarian’s assessment, animal activity levels, and age of the animal. In case studies, Spryng particles provided beneficial effect for greater than one year.

● There is no maximum annual administration frequency.

● Each syringe is for a single use only. Do not use if the package is open or the syringe is damaged.

Disposal

The syringe and any unused material must be discarded after a single treatment visit. Follow national, local, or institutional guidelines for use and disposal of medical sharp devices.

7. Potential Adverse Reactions

Mild, short-term injection-site swelling has been observed. Adverse events should be reported to PetVivo at 844-PET-VIVO (738-8486) or info1@petvivo.com

MADE IN THE USA

Manufactured, marketed, and distributed by PetVivo, Inc., 5251 Edina Industrial Blvd., Minneapolis, MN 55439

844-PET-VIVO (738-8486)

www.petvivo.com

email: info1@petvivo.com

Spryng™ and OsteoCushion™ are trademarks of PetVivo Holdings, Inc.

This product is covered by U.S. Patent Nos. (US 8,153,591; US 9,107,937; US 9,999,705; US 10,850,006; CA 2,537,315; CA 2,583,561) and other pending applications and foreign patents. ©2022 PetVivo, Inc. All rights reserved.

SpryngHealth.com

youtube.com/@sprynghealth

SCIFU-2-1122

Presentation: 3 mL syringe with 2 cc of product.

CPN: 2127000.0

PETVIVO INC.
5151 EDINA INDUSTRIAL BLVD., SUITE 575, MINNEAPLOLIS, MN, 55439
Telephone:   952-405-6216
Toll-Free:   1-844-738-8486
Website:   www.petvivo.com
Email:   info1@petvivo.com
THIS SERVICE AND DATA ARE PROVIDED "AS IS". DVMetrics assumes no liability, and each user assumes full risk, responsibility, and liability, related to its use of the DVMetrics service and data. See the Terms of Use for further details.

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Copyright © 2024 Animalytix LLC. Updated: 2024-11-27