February 2021 – Drug and Device Digest

Marketing Authorizations: TALUS SPACER for ankle avascular necrosis, eXciteOSA for mild obstructive sleep apnea, COSELA for chemotherapy-induced myelosuppression

Patient Specific TALUS SPACER

Additive Orthopaedics, LLC.

INDICATION FOR USE: For avascular necrosis (AVN)of the ankle joint

The anatomical landmarks necessary for the design and creation of the Spacer must be present and identifiable on computed tomography scan


  • AVN is a rare condition that causes the death of bone tissue due to lack of blood supply
  • Implant provides joint-sparing alternative to other surgical interventions commonly used in late-stage AVN


  • Solid, polished replica of the patient’s bone to allow patient to regain motion and reduce pain without amputation
  • Implant is 3D printed in CoCr using a laser sintering platform
  • All surfaces of the device are hand polished to a mirror finish
  • Implant is cleaned and passivated per ASTM A967 and will be sterilized by the end user via steam sterilization.
  • Creation of a patient-specific device is achieved via computed tomography (CT) scanning and CAD/CAM generation
  • No specific instruments are provided with the subject device


  • 31 patients and 32 talus replacement surgeries (one patient had operations on both ankles) with the implant
  • Primary probable benefit endpoint: Reduction in baseline level pain following surgery using the Visual Analog Scale (“VAS”) for pain; secondary endpoints of ankle range of motion, Foot and Ankle Outcome Scores
  • Improvement in scores after surgery with further improvement 2 and 3 years after surgery
  • Few safety events : Pain and scare tissue; most significant risk is reoperation

REGULATORY PATHWAY: Humanitarian Device Exemption

  • Humanitarian Use Designation (HUD); intended to benefit patients for condition that affects not more than 8,000 individuals in the U.S. per year
  • Post-Approval Study (PAS) is a prospective post-approval US registry study to provide ongoing safety and probable benefit assessment



Signifier Medical Technologies, LLC.

INTENDED USE: For the reduction of snoring and obstructive sleep apnoea by strengthening tongue muscles via electrical muscle stimulation

INDICATIONS FOR USE: For use to reduce snoring and mild sleep apnoea (AHI<15) for patients that are 18 years or older


  • OSA has potential serious long-term effects such as heart attack, glaucoma, diabetes, cancer and cognitive and behavioral disorders
  • First device used while awake that is intended to improve tongue muscle function, which in time can help prevent the tongue from collapsing backwards and obstructing the airway during sleep


  • Removable tongue muscle stimulation device that delivers neuromuscular stimulation to the tongue
  • Through a mouthpiece that sits around the tongue; has four electrodes, two located above the tongue and two located below the tongue
  • Provides electrical muscle stimulation action in sessions that consist of a series of electrical pulses with rest periods in between
  • Used for 20 minutes once a day during a wakeful state, for a period of 6‐weeks, and once a week thereafter


  • Clinical study, n= 115 patients with snoring, including 48 patients with snoring and mild OSA
  • Endpoint: 20% time reduction in snoring at levels > 40dB in 87 patients, 48% reduction in Apnea-Hypopnea Index in 41 patients with OSA
  •  Most common adverse events: Excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging and tight jaw
  • Patients should receive a comprehensive dental examination prior to use of the device

REGULATORY PATHWAY: De Novo classification


COSELA (trilaciclib) injection

G1 Therapeutics

INDICATION FOR USE: To decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan containing regimen for extensive-stage small cell lung cancer (ES-SCLC)


  • Protecting bone marrow function may help make their chemotherapy for ES-SCLC safer and improve treatment compliance
  • Treatment option can reduce the occurrence of a common, harmful side effect of chemotherapy

MECHANISM OF ACTION: Transient inhibitor of CDK 4 and 6. Hematopoietic stem and progenitor cells
(HSPCs) in the bone marrow give rise to circulating neutrophils, RBCs, and platelets. HSPC proliferation is dependent on CDK4/6 activity


  • Three randomized, double-blind, placebo-controlled trials, n=245 patients, COSELA vs placebo
  • Primary endpoint: Proportion of patients with severe neutropenia and duration of severe neutropenia in the first cycle of chemotherapy
  • COSELA resulted in lower chance of severe neutropenia vs, placebo; also reduced duration of sever neutropenia
  • Most common side effects: Fatigue; low levels of calcium, potassium and phosphate; increased levels of an enzyme called aspartate aminotransferase; headache; and infection in the lungs (pneumonia)
  • Patients should also be advised about injection site reactions, acute drug hypersensitivity, interstitial lung disease/pneumonitis (lung tissue inflammation) and embryo-fetal toxicity


  • Priority Review and Breakthrough Therapy designations


Image credit: Additive Orthopaedics, Signifier Medical, G1 Therapeutics

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