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11 Medical Devices Recently Approved by FDA

FDA has been busy this year. Check out this list of recently approved devices.

  • FDA has been busy this year in more ways than one. From warning the public about unauthorized devices,  banning summary reports for breast implants, to drafting a variety of new guidance documents,  and saying goodbye to the agency's 23rd commissioner, nobody should accuse FDA of twiddling its thumbs in 2019. But the agency has also approved quite a few premarket approval applications. Here's a look at 11 recent medical devices to be approved for the U.S. market. 

  • Triluron

    Company: Fidia Farmaceutici

    Approval Date: March 26

    What is it? Triluron is a single-use syringe prefilled with sodium hyaluronate. Hyaluronate is a chemical found in the body, and it is present in joint tissues and in the fluid that fills the joints. The body's own hyaluronate acts like a lubricant and a shock absorber in the joint, and it is needed for the joint to work properly. In osteoarthritis, there may not be enough hyaluronate, and there may be a change in the quality of the hyaluronate and its cushioning and lubricating abilities.

    How does it work? Triluron is injected by a doctor directly into the patient's knee and provides relief of pain associated with osteoarthritis for up to six months. The treatment consists of three weekly doses of 2 mL of Triluron.

    When is it used? Triluron is used for the treatment of pain in osteoarthritis of the knee in patients who have not responded to non-surgical treatments from physical therapy and simple pain medicines such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen.

    What will it accomplish? Triluron is intended to relieve pain associated with osteoarthritis in the knee for up to six months after the first injection.

    Read the approval letter for more information.

  • Cerene Cryotherapy Device

    Company: Channel Medsystems

    Approval Date: March 28, 2019

    What is it? The Cerene Cryotherapy Device is an endometrial ablation device that uses a freezing agent to destroy (ablate) the lining of the uterus (endometrium) to reduce heavy menstrual bleeding.

    How does it work? A gynecologist uses the Cerene Cryotherapy Device to ablate the endometrial lining of a woman's uterus and reduce heavy menstrual bleeding. The device has a slim probe that the gynecologist inserts through the cervix and into the woman's uterus. Once inserted, a freezing agent is released, and the endometrial lining of the uterus is destroyed.

    When is it used? The device is intended to be used in pre-menopausal women with heavy menstrual bleeding due to benign (non-cancerous) causes who do not want to become pregnant in the future.

    What will it accomplish? The device destroys the endometrial lining of the uterus to reduce menstrual bleeding. In the pivotal clinical study, 76% of women observed a reduction in menstrual blood loss from an excessive level to normal or less than normal levels.

    Read the approval letter for more information.

  • therascreen FGFR RGQ PCR Kit

    Company: Qiagen Manchester

    Approval Date: April 12, 2019

    What is it? The therascreen fibroblast growth factor receptor (FGFR) Rotor-Gene Q (RGQ) polymerase chain reactions (PCR) kit tests a tumor sample from patients with urothelial cancer for genetic mutations in certain fibroblast growth factor receptor (FGFR2 and FGFR3) genes. These genetic mutations may cause cancer to grow. 

    When is it used? Doctors use the therascreen FGFR RGQ PCR kit laboratory test to select the best treatment options for a patient with urothelial cancer, including determining whether Balversa (erdafitinib), a drug that slows the growth of tumors that have certain mutated FGFR genes, is a treatment option.

    How does it work? The doctor takes a small amount of tumor tissue from the patient’s tumor and sends it to a lab. At the lab, ribonucleic acid (RNA) is isolated from the patient’s tumor cells and mixed with reagents that specifically make copies of the tumor’s FGFR genes. Different colored dyes are used to detect normal FGFR genes and mutant FGFR genes. The lab results are reported to the patient’s doctor, who then uses this information to help select the best treatment options for their urothelial cancer patients, including determining whether Balversa™ (erdafitinib) is a treatment option.

    What will it accomplish? The therascreen FGFR RGQ PCR Kit helps to determine whether patients with urothelial cancer should be considered for treatment with Balversa (erdafitinib), which may prolong their life.

    Read the approval letter for more information.

  • TherOx DownStream System

    Company: TherOx

    Approval Date: April 2, 2019

    What is it? The TherOx DownStream System delivers super-oxygenated blood (super-saturated oxygen therapy, or SSO2) within the heart arteries (specifically, the left anterior descending (LAD) coronary artery) near the damaged area of the heart, following successful placement of a stent.

    How does it work? The device creates an oxygen-enriched saline solution called super-saturated oxygen solution ("SSO2 solution"). A small amount of the patient's own blood is mixed with the SSO2 solution, producing super-oxygenated blood. The SSO2 delivery catheter then delivers the super-oxygenated blood within the LAD near the damaged area of the heart. The duration of SSO2 therapy is about one hour.

    When is it used? The TherOx DownStream System is used for patients who have recently experienced a heart attack with damage to the left top (anterior) side of the heart muscle and received successful stenting within six hours of the start of heart attack symptoms.

    What will it accomplish? The TherOx DownStream System is intended to reduce damage to the heart following a heart attack. In clinical studies, some patients treated with the TherOx DownStream System experienced a reduction in the amount of damaged heart muscle compared with patients with a similar level of risk receiving a stent alone.

    Read the approval letter for more information.

  • TransPyloric Shuttle/TransPyloric Shuttle Delivery Device

    Company: BAROnova

    Approval Date: April 16, 2019

    Read MD+DI's story covering the approval of this device.

    What is it? The TransPyloric Shuttle (TPS) is a weight-loss system that uses a removable gastric balloon that affects flow out of the stomach. The TPS is temporary and should be removed after 12 months.

    How does it work? The TPS is placed into the patient's stomach through their mouth during a minimally invasive endoscopic procedure. Once in place, the TPS is formed using the TPS Delivery Device. The TPS forms a smooth large bulb connected to a smaller bulb by a flexible silicone tether. The large bulb remains in the stomach and the small bulb is designed to remain either in the stomach or cross the stomach into the small intestine to slow the time it takes for food to leave the stomach and enter the small intestine (gastric emptying). The TPS remains in the stomach for up to 12 months to help patients lose weight.

    When is it used? The TransPyloric Shuttle/TransPyloric Shuttle Delivery Device is used in obese adult patients with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with an associated medical condition (for example, diabetes) who have been unable to lose weight diet and behavior modification program, and exercise. It is intended to be used while a patient participates in a diet and exercise plan supervised by a health care provider.

    What will it accomplish? During the clinical study, the TransPyloric Shuttle/TransPyloric Shuttle Delivery Device was implanted in patients for up to one year. The study showed 66% of treated patients observed at least a 5% reduction in their total body weight compared to 30% of patients who did not receive the device but underwent the procedure for placement of the device. Treated patients lost an average of 9.3% of their body weight, and patients who underwent the procedure but did not receive the device lost 2.8% of their body weight.

    Read the approval letter for more information.

  • XVIVO Perfusion System (XPS) with STEEN Solution Perfusate

    Company: XVIVO Perfusion

    Approval Date: April 26, 2019

    What is it? The XVIVO Perfusion System (XPS) with STEEN Solution is intended to be used on donor lungs prior to transplantation in patients with end-stage lung disease. The XPS with STEEN Solution consists of the XPS Perfusion Cart Hardware, fluid path and non-fluid path disposables, XPS Cart Software, and STEEN Solution. The XPS System is responsible for housing the organ for preservation, providing an environment close to body temperature, and perfusing the organ with the STEEN Solution. The STEEN Solution is a clear, sterile, non-pyrogenic (does not cause fever), non-toxic physiological salt solution containing human serum albumin (HSA) and dextran 40 that is designed for use as a temporary, continuous machine perfusion solution for assessment of isolated lungs after removal from the donor.

    How does it work? The XPS System warms the donor lungs to near normal body temperature and continuously flushes the lung tissue with the STEEN Solution, which preserves the lungs and removes waste products. The XPS System also ventilates the lungs, which oxygenates the cells and makes it possible for the transplant team to examine the airways of the lungs with a bronchoscope. Donor lungs can stay in the machine for up to five hours; during this time the transplant team can examine the lungs and evaluate their function. If the lungs meet certain functionality criteria, and pass the transplant surgeon’s examination, they are transplanted into a recipient.

    When is it used? The XPS System with STEEN Solution Perfusate is used only on previously unaccepted donor lungs that will be transplanted into a patient with end-stage lung disease.

    What will it accomplish? The use of XPS System with STEEN Solution Perfusate may increase the donor pool by allowing the safe transplantation of initially unacceptable donor lungs. This includes:

    • Allowing time for the lung(s) to re-establish their normal condition in an optimized environment;
    • Restoring physiologic problems caused by neurogenic pulmonary edema (e.g., electrolytic balance, colloid-osmotic pressure, and temperature);
    • Diluting and filtering away any remaining donor blood and/or clots still in the lung(s);
    • Allowing for re-expansion of atelectatic lung areas;
    • Allowing time to assess and clean/suction bronchial secretions; and
    • Facilitating perfusion of the pulmonary micro-vasculature with the use of dextran in the STEEN Solution Perfusate.

    Read the approval letter for more information.

  • Tack Endovascular System (6F)

    Company: Intact Vascular

    Approval Date:  April 11, 2019

    Read MD+DI's previous coverage of this device.

    What is it? The Tack Endovascular System (6F) is intended to repair a tear (dissection) in the inside lining of a blood vessel that may have occurred following a procedure (balloon angioplasty) to improve blood flow by widening a blocked or narrowed blood vessel in the leg. The Tack Endovascular System (6F) consists of six self-expanding “Tack” implants made of a nickel-titanium alloy (nitinol) and a delivery catheter system. The delivery catheter is a long, thin, tube-like device used to deliver the Tack(s) into the artery.

    How does it work? First, the doctor inserts the Tack Endovascular System (6F) delivery catheter, which comes pre-loaded with six self-expanding tacks, into the leg and moves the Tack Endovascular System (6F) to the area to be treated. Then, based on the size of the tear, the doctor decides how many Tacks from the catheter to use. Next, the doctor removes the delivery catheter and the Tack(s) stay permanently implanted in the leg to allow blood to flow in the leg while the tear heals.

    When is it used? The Tack Endovascular System (6F) is used to treat patients who have a tear in the blood vessels in their leg that occurred from a balloon angioplasty procedure.

    What will it accomplish? The Tack Endovascular System (6F) is designed to repair tears of the inner wall of an artery in the leg that may have occurred during balloon angioplasty procedure. In a clinical study, The Tack Endovascular System (6F) was successfully used in 204 out of 213 patients (96%) in the United States and Austria. Also, 81% of patients showed improvement in their leg symptoms one year after treatment. 

    Read the approval letter for more information.

  • Vici Venous Stent System

    Company: Boston Scientific

    Approval Date: May 2, 2019

    Read MD+DI's coverage of the approval

    What is it? The Vici Venous Stent System is intended to treat a narrowed vein found in the upper pelvic region down to the groin area (iliofemoral vein). The Vici Venous Stent System has two components: a stent made of a nickel-titanium alloy (nitinol) tubing and an over-the-wire stent delivery catheter system.

    How does it work? The physician will insert a thin flexible tube (delivery system) with a stent loaded within its tip into the narrowed section of the iliofemoral vein. The physician pulls back on the outer shaft of the delivery system to expose the stent which then self-expands automatically. The stent increases blood flow from the leg by holding the iliofemoral vein wall open. The stent remains permanently implanted in the vein and supports the newly opened section of iliofemoral vein.

    When is it used? The Vici Venous Stent System is used reopen narrowed regions of the iliofemoral vein caused by a collection of blood clots that can form along the lining of the veins following a deep vein thrombosis (post-thrombotic syndrome) or the squeezing of the iliofemoral vein between a bone and an overlying artery (iliofemoral compression). These conditions may limit blood flow from the leg and lead to swelling of the leg and pain when walking.

    What will it accomplish? The Vici Venous Stent System opens the narrowed iliofemoral vein to improve blood flow from the leg. In a clinical study, which included 170 patients who had post-thrombotic syndrome or iliofemoral compression, about 84% of patients who received stents continued to have an open iliofemoral vein after one year. 

    Read the approval letter for more information.

  • Lotus Edge Valve System

    Company: Boston Scientific

    Approval Date: April 23, 2019

    Read MD+DI's coverage of the approval

    What is it? The Lotus Edge Valve System is a transcatheter aortic valve replacement system that consists of an artificial aortic heart valve and a delivery system used to implant the valve without the need for open-heart surgery. The valve is made of natural tissue obtained from the heart of a cow that is attached to a metal (nickel-titanium) frame for support. The valve is available in three sizes: 23 mm, 25 mm, and 27 mm.

    How does it work? The Lotus Edge valve is compressed and loaded inside the end of a tube-like device called a delivery catheter. The delivery catheter and valve are then inserted into the body through a blood vessel, usually an artery in the leg, and pushed through the blood vessels until it reaches the diseased aortic valve in the heart. The handle of the delivery system is used to mechanically expand the Lotus Edge Valve until it secures to the patient's diseased valve. Then the valve is released and the delivery system is taken out of the body. Once in place, the new valve functions the same as the old valve by opening and closing properly to guide the blood flow in the right direction.

    When is it used? Lotus Edge is used in patients whose aortic heart valve is diseased due to calcium build up, which causes the valve to narrow (aortic stenosis) and restricts blood flow through the valve. As the heart works harder to pump enough blood through the smaller opening, the heart eventually becomes weak. This can lead to symptoms and life-threatening heart problems such as fainting, chest pain, heart failure, irregular heart rhythms (arrhythmias), or abrupt loss of heart function (cardiac arrest).

    The Lotus Edge Valve is used in patients who cannot undergo or are at high risk for open-heart surgery as determined by their heart team (a cardiologist and surgeon).

    What will it accomplish? Lotus Edge can help restore normal blood flow in the hearts of patients with severe aortic stenosis who need replacement of their diseased valve, but for whom the surgical procedure is highly risky, or too risky. For these patients, clinical studies showed that Lotus Edge is reasonably safe and effective and patients showed improvement in how their heart functioned without the need for open heart surgery. However, implanting the Lotus Edge also carries the risk of serious complications such as death, stroke, kidney injury, heart attack, bleeding, and the need for a permanent pacemaker.

    Read the approval letter for more information.

  • Neuroform Atlas Stent System

    Company: Stryker Neurovascular

    Approval Date: May 16, 2019

    What is it? The Neuroform Atlas Stent System is intended to hold in place coil devices used to plug up aneurysms in the brain that have a neck size greater than or equal to 4 mm or a dome-to-neck ratio less than 2 (wide-necked brain aneurysms). The Neuroform Atlas Stent System consists of a self-expandable metal (nitinol) tube-shape device (stent) and a wire to place it inside a brain artery.

    How does it work? A physician inserts the delivery wire containing the Neuroform Atlas stent with a small catheter through a cut into a large artery in the groin (femoral artery). The Neuroform Atlas stent is carefully guided to the aneurysm and permanently implanted to hold in place embolization coils implanted in the sac of the aneurysm.

    When is it used? The Neuroform Atlas Stent System is indicated for use with neurovascular embolization coils in the anterior circulation of the brain for patients 18 years of age or older with saccular wide-necked brain aneurysms arising from an artery (parent vessel) with a diameter of greater than 2.0 mm and less than 4.5 mm.

    What will it accomplish? In a clinical study of 182 patients treated with the Neuroform Atlas Stent System, the aneurysms in 85% of these patients were completely sealed off at one year without the need for re-treatment or significant narrowing of the parent artery (stenosis).

    Read the approval letter for more information.

  • NovoTTF-100L System

    Note: This device was approved as a humanitarian device exemption (HDE).

    Company: Novocure

    Approval Date: May 23, 2019

    What is it?  The NovoTTF-100L System is the first device indicated to be used in conjunction with a standard two-drug chemotherapy to treat patients with a cancerous tumor, malignant pleural mesothelioma (MPM) that is unable to be removed via surgery (unresectable). 

    The NovoTTF-100L System is a portable device that consists of a generator, transducer arrays (insulated ceramic discs), connection cables, power supply, carrying bag, battery, and battery charger.  Transducer arrays connected from the device to a patients’ chest deliver the treatment to the patient.  Patients are prescribed the device for use at home by a licensed physician who is trained to use the device, and can train patients and caregivers to use the device, and monitor patients under their care.

    How does it work?  The NovoTTF-100L System produces alternating electrical fields, called tumor treatment fields (TTFields) within the torso.  TTFields are applied to the patient by adhesive bandages that hold transducer arrays.  The transducer arrays are believed to disrupt the rapid cell division of cancer cells, inhibiting tumor growth and causing affected cancer cells to die.  Patients use the device at home for at least 18 hours a day (with minimal breaks) until disease progression or in the absence of significant toxicity.  The device is plugged into a power supply or uses the rechargeable battery when a patient wants to move around while wearing the device.  Patients do not need to change any of the device’s settings in order to use it.

    When is it used?  A licensed physician may prescribe the NovoTTF-100L System to treat a patient with malignant pleural mesothelioma (called MPM) which cannot be cured with surgery or radiation.  The NovoTTF-100L System is a treatment option used in addition to chemotherapy.

    The NovoTTF-100L System is used for the treatment of adult patients with unresectable, locally advanced and metastatic, malignant pleural mesothelioma (MPM) to be used concurrently with pemetrexed and platinum-based chemotherapy.

    What will it accomplish?  A clinical trial of 80 patients with unresectable MPM who used the NovoTTF-100L System along with a standard 2-drug chemotherapy regimen was conducted.  The median overall survival for patients was about 18 months.  The data showed that the NovoTTF-100L System has the potential to extend life expectancy in this patient population.

    In the clinical trial, the most common complication of using the device (in 57 of 80 patients) included skin irritation, red rash, and small sores or blisters on a patient’s skin where the transducer arrays attached to the chest. Patients with mild-to-moderate skin irritation were treated with steroid cream and by relocating the transducer arrays to other parts of the chest or back.  Four patients reported severe skin problems.  In all cases of severe skin problems, the rash went away after stopping treatment.

    Read the HDE approval letter for more information.

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