Acellular Tissue Engineered Vessel

Acellular Tissue Engineered Vessel is indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and when autologous vein graft is not feasible.

• Acellular Tissue Engineered Vessel is available under the following different brand names: Symvess, acellular tissue-engineered vessel-tyod.

Common side effects of Acellular Tissue Engineered Vessels include:

• thrombosis 
• fever
• pain
• anastomotic stenosis
• rupture or anastomotic failure
• infection

Serious side effects of Acellular Tissue Engineered Vessels include:

• not available

Rare side effects of Acellular Tissue Engineered Vessels include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors.
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

• Engineered vessel composed of organized extracellular matrix (ECM) proteins
• Provided as follows: 6 mm in internal diameter and 42 cm in length
• Once removed from the packaging, its usable length is approximately 40 cm
• Each package (i.e., a box containing Tyvek-sealed tray) contains one symvess unit for administration to a single patient only

Vascular trauma

Adult dosage

• Administered by surgical implantation to replace injured extremity artery
• The anatomical location of the extremity and length required is determined by the surgeon implanting the graft based on the appropriate preoperative clinical evaluation, vessel mapping and/or imaging, and intra-operative considerations
• Product may be trimmed to provide the appropriate length required for artery replacement; also, can be trimmed to replace 1 and more injured extremity arteries for the same patient

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Acellular Tissue Engineered Vessel has no noted severe interactions with any other drugs
• Acellular Tissue Engineered Vessel has no noted serious interactions with any other drugs
• Acellular Tissue Engineered Vessel has no noted moderate interactions with any other drugs
• Acellular Tissue Engineered Vessel has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

Patients who have a medical condition that would preclude long-term antiplatelet therapy (e.g., aspirin, clopidogrel) after the resolution of acute injuries

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Acellular Tissue Engineered Vessel?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Acellular Tissue Engineered Vessel?”

Cautions

• Graft rupture
  • Vascular graft rupture has occurred
  • Advise patients that arterial bleeding can be life-threatening and to seek emergent medical evaluation for any signs or symptoms of graft rupture (e.g., bleeding, pain and swelling in extremity, or signs of extremity ischemia)
• Anastomotic failure
  • Anastomotic failure has occurred
  • In clinical studies, anastomotic failure occurred within the first 36 days post-implantation
  • Monitor patients for signs of anastomotic failure (e.g., pain and swelling at the surgical site, decreasing hemoglobin, or other signs and symptoms of bleeding)
  • Advise patients to seek urgent medical evaluation if they have any signs or symptoms that may be indicative of anastomotic failure (e.g., bleeding, swelling, or worsening pain at the surgical site, or changes in color of the overlying skin)
• Thrombosis
  • Thrombosis has occurred
  • In clinical trials, patients received antiplatelet therapy following implantation to reduce thrombosis risk
  • Risk of thrombosis may increase in patients who discontinue antiplatelet therapy
  • Antiplatelet therapy is recommended following treatment
• Transmission of infectious diseases
  • Manufactured using cells and reagents that may transmit infectious diseases or infectious agents
  • Cells used in manufacture are derived from a donor who met the donor eligibility requirements for transmissible infectious diseases, which includes screening and testing of risks associated with human immunodeficiency virus 1 (HIV-1), human immunodeficiency virus 2 (HIV-2), hepatitis B virus (HBV), hepatitis C virus (HCV), and syphilis (Treponema pallidum)
  • Cell banks are tested negative for human and animal viruses, retroviruses, bacteria, fungi, yeast, and mycoplasma
  • While all animal-derived reagents are tested for animal viruses, bacteria, fungi, and mycoplasma before use, these measures do not eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents
  • Fetal bovine serum is sourced to minimize the risk of transmitting a prion protein that causes bovine spongiform encephalopathy and a rare fatal condition in humans called variant Creutzfeldt-Jakob disease
  • No transmissible agent infections have been reported during clinical testing

Pregnancy and Lactation

Clinical data are limited regarding use in pregnant women and are insufficient to inform a drug-associated risk

No animal reproductive and developmental toxicity studies have been conducted to assess whether it can cause harm to the mother or fetus when administered to a pregnant woman

Lactation

• There is no information regarding the transmission of antibodies or any product components in human milk, effects on breastfed infants, or effects on milk production
• Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for symvess and any potential adverse effects on breastfed infants from the product or underlying maternal condition