Symvess
Generic: ACELLULAR TISSUE ENGINEERED VESSEL
Basic Information
Manufacturer
Humacyte Global, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVASCULAR
FDA Set ID
15e9e29f-5aa6-4fc6-b0fe-a48cd1473418
Indications & Usage
1 INDICATIONS AND USAGE SYMVESS™ is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
SYMVESS™ is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
( 1 )
SYMVESS™ is an acellular tissue engineered vessel indicated for use in adults as a vascular conduit for extremity arterial injury when urgent revascularization is needed to avoid imminent limb loss, and autologous vein graft is not feasible.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (incidence ≥3%) were thrombosis, fever, pain, anastomotic stenosis, rupture or anastomotic failure, and infection.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Humacyte Global, Inc.
at 1-833-591-0081 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to adverse reaction rates in clinical trials of other products, and they may not reflect the rates observed in real-world clinical practice.
The safety data described in this section reflect exposure to SYMVESS in one single arm, open-label study in patients requiring vascular replacement or reconstruction for life or limb threatening vascular trauma, Study 1 (CLN-PRO-V005; NCT03005418).
A total of 54 adults received extremity implantation of SYMVESS as a vascular conduit.
The patient population ranged in age from 18 to 72 years (mean age 33 years).
Each patient received a SYMVESS implant ranging in length from 1 to 35 cm (mean length 10.1 cm).
The most frequently occurring adverse reactions are shown in Table 1 .
Table 1 Adverse Reactions Occurring with a Frequency of ≥3% in Study 1 Adverse Reaction Adverse Reaction Frequency based on up to 3 years follow-up data [median 191 days (range 1-1134 days)] Extremity Patients (%) Extremity patients are with arterial repair in upper or lower limbs (n=54) Vascular graft thrombosis 15 (28%) Pyrexia (fever) 9 (17%) Pain 8 (15%) Anastomotic stenosis 5 (9%) Vascular graft rupture or anastomotic failure 4 (7%) Vascular graft infection 3 (6%) Long term follow-up of up to 36 months in Study 1 is ongoing.
At the data cut-off date, 7 out of 54 patients in the extremity group have completed the study (i.e., completed 36 months of follow-up).
The safety of SYMVESS beyond 36 months was not evaluated in the clinical studies for this indication.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Humacyte Global, Inc.
at 1-833-591-0081 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a product cannot be directly compared to adverse reaction rates in clinical trials of other products, and they may not reflect the rates observed in real-world clinical practice.
The safety data described in this section reflect exposure to SYMVESS in one single arm, open-label study in patients requiring vascular replacement or reconstruction for life or limb threatening vascular trauma, Study 1 (CLN-PRO-V005; NCT03005418).
A total of 54 adults received extremity implantation of SYMVESS as a vascular conduit.
The patient population ranged in age from 18 to 72 years (mean age 33 years).
Each patient received a SYMVESS implant ranging in length from 1 to 35 cm (mean length 10.1 cm).
The most frequently occurring adverse reactions are shown in Table 1 .
Table 1 Adverse Reactions Occurring with a Frequency of ≥3% in Study 1 Adverse Reaction Adverse Reaction Frequency based on up to 3 years follow-up data [median 191 days (range 1-1134 days)] Extremity Patients (%) Extremity patients are with arterial repair in upper or lower limbs (n=54) Vascular graft thrombosis 15 (28%) Pyrexia (fever) 9 (17%) Pain 8 (15%) Anastomotic stenosis 5 (9%) Vascular graft rupture or anastomotic failure 4 (7%) Vascular graft infection 3 (6%) Long term follow-up of up to 36 months in Study 1 is ongoing.
At the data cut-off date, 7 out of 54 patients in the extremity group have completed the study (i.e., completed 36 months of follow-up).
The safety of SYMVESS beyond 36 months was not evaluated in the clinical studies for this indication.