Recently Approved Devices

The FDA has recently approved the following devices to be marketed.

TRILURON™ - P180040 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.

Cerene Cryotherapy Device - P180032 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.

therascreen® FGFR RGQ PCR Kit - P180043 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.

TherOx DownStream System - P170027 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.

TransPyloric Shuttle/TransPyloric Shuttle Delivery Device - P180024 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.

XVIVO Perfusion System (XPS™) with STEEN Solution™ Perfusate - P180014 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™.

Tack Endovascular System® (6F) - P180034 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.

VICI VENOUS STENT® System - P180013 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.

LOTUS Edge™ Valve System - P180029 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.

Neuroform Atlas® Stent System - P180031 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.

NovoTTF™-100L System - H180002 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).