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10 Medical Devices Recently Approved by FDA

  • From companion diagnostic tests to ear tubes for children and adults suffering from repeated ear infections, FDA reviewers stayed busy in the final months of 2019. The agency recently approved the following devices to be marketed in the United States.

    Image by OpenClipart-Vectors on Pixabay
  • Abbott's CentriMag Circulatory Support System

    FDA approved Abbott's CentriMag Circulatory Support System on Dec. 6, 2019. The blood pump system is intended to be used temporarily to help the heart pump blood in patients whose circulatory systems (heart and blood vessels) are not able to perform well enough on their own.  The CentriMag Circulatory Support System includes a blood pump, a motor that drives the pump, a console that controls the motor, a monitor, a flow probe, and flexible tubes (cannulae).

    The system pumps blood from the heart to either a blood vessel that supplies blood to most of the body (ascending aorta) or one that supplies blood to the lungs (main pulmonary artery), depending on how it is used. The pump is located outside of the patient’s body and is connected to the heart and the blood vessels using thin tubes (cannulae) inserted into a vein.  The cannulae are implanted in the patient surgically.

    The CentriMag System can be used to provide support for function of the left, right, or both heart ventricles after cardiac bypass surgery. The device is implanted surgically in the hospital. Patients with the device must stay in the hospital until it is removed, which may be up to 30 days.

    By helping the heart pump blood for up to 30 days, the device allows the heart and the blood vessels to recover and get stronger after cardiac bypass surgery. Once they get stronger, the device’s cannulae attached to the heart and blood vessels are removed. If the heart does not recover enough of its function while on the device, the patient may need a different treatment.

    In a clinical study, 69% (22 out of 31) of the patients survived for at least 30 days after the device was removed.

    FDA said the CentriMag System should not be used as a cardiotomy suction device. It should also not be used for patients who are unable or unwilling to use a blood thinner (anti-coagulant) like Heparin while they have the device.

  • Foundation Medicine's FoundationOne CDx

    Approved by FDA on Dec. 3, 2019, Foundation Medicine's FoundationOne CDx (F1CDx) is a laboratory test designed to detect genetic mutations in 324 genes and two genomic signatures in tumor tissue. F1CDx is a companion diagnostic that was originally approved for the detection of genetic mutations in patients who may be eligible for treatment with one of 15 FDA-approved therapies for non-small cell lung cancer, melanoma, breast cancer, colorectal cancer, and ovarian cancer. This approval expands the indications for use of the F1CDx test to include breast cancer patients with certain genetic mutations in the PIK3CA gene. Identifying these changes will help breast cancer patients get personalized treatment with PIQRAY (alpelisib), a drug used to treat patients with breast cancer.

    How it works: The doctor obtains a piece of tissue from the breast tumor of a patient, and the specially prepared sample is sent to Foundation Medicine where the DNA is isolated from a breast tumor tissue section, and then mixed with chemical substances, called reagents, that detect and analyze the DNA sequences. The patient’s sequenced DNA is then evaluated for the presence or absence of PIK3CA mutations. A trained medical professional reviews the results, and a report is sent to the patient's doctor. The presence of a mutation in the PIK3CA gene in a patient’s cancer tissue indicates that a patient with advanced or metastatic breast cancer is eligible for treatment with PIQRAY (alpelisib).

  • LIAISON QuantiFERON-TB Gold Plus

    FDA approved DiaSorin's LIAISON QuantiFERON-TB Gold Plus assay, LIAISON Control QuantiFERON-TB Gold Plus, and LIAISON QuantiFERON Software on Nov. 26, 2019.

    DiaSorin's LIAISON QuantiFERON-TB Gold Plus in vitro diagnostic test is intended to determine if a person could be infected with tuberculosis (TB) bacteria. The LIAISON Control QuantiFERON-TB Gold Plus is used as a quality control to ensure the test is working properly. The LIAISON QuantiFERON-TB Software is used to analyze the test results on the LIAISON XL Analyzer.

    How it works: A healthcare provider collects a patient’s blood sample using the QuantiFERON-TB Gold Plus Blood Collection Tubes and sends them to a laboratory for testing. Because these tubes contain tuberculosis proteins, the patient’s blood will react if a person has been infected with tuberculosis. Patient blood is removed from the collection tubes and mixed with test chemicals using the LIAISON XL Analyzer and evaluated. Laboratory clinicians or the LIAISON QuantiFERON-TB Software can calculate a result. Doctors use the test result together with a patient’s medical history, physical examination, X-ray, and other medical evaluations to help diagnose TB infection. The assay should not be used as the only test for diagnosing a TB infection, FDA noted.

  • Tusker Medical's Tula System

    On Nov. 25, 2019, FDA approved Tusker Medical's Tula System, which is intended to insert ear tubes (tympanostomy tubes) into the eardrum to treat repeated ear infections or fluid in the ear in young children and adults using local anesthesia in a physician’s office. The Tula System consists of the Tula Iontophoresis System and the Tula Tube Delivery System.  The Tula Iontophoresis System, which includes individually-fitted disposable ear plugs and ear sets, delivers a local anesthetic solution, Tymbion, to the eardrum resulting in numbness of the eardrum. The Tula Tube Delivery System is then used to place the ear tube in the eardrum.   

    How it works: The Tula Iontophoresis System uses a small electrical current to deliver the Tymbion to the eardrum prior to tube insertion. The fitted earplugs keep the local anesthetic solution in the ear canal. Once the eardrum is adequately numb, the physician removes the earplugs and uses the Tula Tube Delivery System to create a small hole in the eardrum and insert the ear tube. 

    The effectiveness of the Tula System for the delivery of ear tubes was assessed in a clinical study of 222 pediatric patients, ages 6 months to 12 years.  Physicians were successful in placing ear tubes using the Tula System in 86% (103 of 120) of children ages 6 months to 4 years and in 89% (91 of 102) of children ages 5 to 12 years.

    In the same study, pain and distress related to the procedure were evaluated. A video-based pain scoring method was used for younger children, ages 6 months to 4 years.  Older children, ages 5 to 12 years, self-reported pain scores.  For all patients, pain and distress were rated using a 0 to10 scale, where 10 represents severe pain or distress, and 0 represents no pain or distress.  Children ages 6 months to 4 years had an average observed score of 4.0 for the ear tube insertion phase of the procedure, which decreased to 1.3 at the end of the procedure.  Children ages 5 to12 years with successful ear tube insertion reported an average score of 3.3 for the tube insertion phase of the procedure, which decreased to 1.7 at the end of the procedure.

    FDA noted that the system should not be used in patients with any of the following conditions:

    • An ear drum that is unusually thin, has a hole in it, or has not completely healed from a previous condition
    • Injuries or cuts in the ear canal
    • Abnormal blood vessels behind the ear drum
    • An infection in the ear canal, referred to as otitis externa or swimmer’s ear
    • Implantable electronic medical support systems, such as pacemakers, defibrillators, or cochlear implants
    • A history of developing an allergic reaction to local anesthetic, or numbing, medications, or to any of the added Tymbion ingredients
    • A family history of insensitivity to the numbing action of local anesthetic medications, including lidocaine
    • Unusual ear anatomy that would prevent ear tube placement in the desired location
  • CooperVision's MiSight Contact Lens

    On Nov. 15, 2019 FDA approved the first contact lens designed to slow the progression of nearsightedness in children. By slowing the progression of nearsightedness (myopia), the new lenses may also reduce the child's risk of developing more serious eye problems in adulthood.

    Until now, traditional eyeglasses and contact lenses available in the United States have only been developed to correct blurred vision (a symptom of myopia), but not for slowing the progression of the condition.

    How it works: One part of the contact lens bends light so it focuses on the back of the eye, allowing the child to see images clearly. Another part of the contact lens bends light so it focuses in front of the back of the eye, to slow the progression of nearsigthedness over time.

    To read more about CooperVision's MiSight daily wear contact lenses, click here.

  • Axonics Sacral Neuromodulation System

    FDA approved an implantable rechargeable sacral neuromodulation (r-SNM) device developed by Axonics for two separate indications. First, the agency approved the device on Sept. 6, 2019 for the treatment of fecal incontinence. Then, on Nov. 13, 2019, the agency approved the urinary indications (urinary urge incontinence, urinary urge frequency, underactive bladder, or urinary retention) for the device. Both approvals also cover the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted.

    Axonics was MD+DI readers' choice for 2019 Medtech Company of the Year.

  • Myriad Genetic Laboratories' myChoice CDx

    On Oct. 23, 2019, FDA approved the Myriad myChoice CDx, a laboratory test designed to detect homologous recombination deficiency (HRD) status. A positive HRD status means that there are mutations in BRAC1 and BRCA2 genes or a high Genomic Instability Score (GIS) in patients with ovarian cancer. With a positive HRD status, a patient’s DNA is unable to repair. Ovarian cancer patients with a positive HRD status are eligible for treatment with Zejula (niraparib).

    How it works: The doctor takes a small amount of cancer tissue from a patient’s tumor and sends it to a lab. The lab isolates DNA from the patient’s tumor tissue and mixes with substances (called reagents) to create chemical reactions to determine DNA sequences. The patient’s DNA sequences are then evaluated for changes in BRCA1 and BRCA2 genes.


    Approved by FDA on Oct. 18, 2019, DiaSorin's LIAISON XL MUREX HCV Ab is a laboratory test used to detect antibodies to the hepatitis C virus (HCV) in a patient’s blood. The presence of antibodies against HCV can help determine if a patient has been exposed to HCV but will not be able to tell if a patient has a recent or chronic HCV infection, or if a patient has recovered from HCV infection. The test is used with the LIAISON XL analyzer, which is designed to conduct the test and analyze the results. The LIASON XL MUREX Control HCB Ab is used to check that the test is working properly.

  • AMO Manufacturing's  iDesign Refractive Studio (iDesign) and STAR S4 IR Excimer Laser System 

    On Sept. 9, 2019, FDA approved expanded indications for AMO Manufacturing's iDesign Refractive Studio and STAR S4 IR Excimer Laser System. The technology is now approved for wavefront-guided photorefractive keratectomy (PRK) to reduce or eliminate nearsightedness (myopia) with or without astigmatism (a refractive error in which the eye focuses light rays more strongly in one direction than another).

    How it works: The systems are used for PRK, a type of surgery used to correct vision by reshaping the top surface of the cornea using a laser. Before the laser treatment, the doctor uses iDesign to measure the patient’s eye and determine how the cornea should be re-shaped to improve the vision. The laser can produce rapid pulses that remove small and precise amounts of corneal tissue. The doctor then uses the laser to re-shape the cornea as determined by iDesign. The treatment is guided by the treatment plan from the iDesign, including the wavefront measurements. The treatment is intended to correct nearsightedness with or without astigmatism and help patients see distant objects better without glasses or contact lenses.

  • Alcon's AcrySof IQ PanOptix Trifocal Intraocular Lens and AcrySof IQ PanOptix Toric Trifocal Intraocular Lens 

    FDA approved expanded indications of Alcon's AcrySof IQ PanOptix Trifocal Intraocular Lens (IOL) and AcrySof IQ PanOptix Toric Trifocal Intraocular Lens (IOL) on Aug. 26, 2019. These artificial lenses are designed to be implanted in the eye. The AcrySof IQ PanOptix Toric IOL is an aritificial lens implant that is used to improve vision after cataract removal in people who also have blurred vision due to an irregularly shaped cornea (corneal astigmatism). This approval expands the use to provide improved intermediate clear vision (for example, working on a computer, applying makeup, or shaving) and near clear vision (for example, reading, writing, and sewing).

    The IOLs work by bending light rays to allow them to focus on the retina (the back surface of the eye) to provide for improved distance (for example, driving, playing golf), intermediate, and near vision. They are implanted in patients who are 22 years of age or older, with less than 1 diopter of pre-existing corneal astigmatism, and have had cataract surgery.

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