The FDA's Breakthrough Devices Program is a voluntary program aimed at accelerating the review of breakthrough technologies or technologies that can more effectively treat or diagnose life-threatening or irreversible debilitating diseases or conditions. According to data from PharmSmart Medical Devices, there are a total of 32 breakthrough device products that have been approved for market by the US FDA in 2024.

According to publicly available information from the FDA, the types of 32 products are mainly focused on passive implantable devices, with orthopedic and cardiovascular implants being the main ones. This article introduces 14 types of implantable devices, as follows:

01. Chest and Abdominal Branch Stent (W.L. GORE&ASSOCYTES, INC.)
Indications: Patients with thoracoabdominal aortic aneurysm, as well as those with high surgical risk and proximal renal aortic aneurysm.

The main researcher of this product, Dr. Michel Makarou, director of vascular surgery at the University of Pittsburgh School of Medicine, stated that "this early feasibility study included two specifications of the TAMBE device. In addition to the original compliant renal branch specification, another new compliant specification was evaluated that allows all branches to be placed from the patient's arm.

Compliant specifications have the characteristic of shorter product tube length and higher adaptability to anatomical structures of more patients; The integrated system consists of four pre formed portal branches, which can be used to place the stent graft onto visceral branch blood vessels. In addition, the compliant specification also retains an intuitive staging placement system designed to assist doctors in repositioning the graft and facilitating selective intubation of each branch throughout the entire placement process.

02. Transcatheter tricuspid valve replacement system (EDWARDS LIFESCENCES, LLC)
Indications: The EVOQUE system (Transcatheter tricuspid valve replacement system) can replace the native tricuspid valve without the need for open chest surgery or simultaneous removal of the failed native tricuspid valve.

The EVOQUE system includes the EVOQUE valve, EVOQUE tricuspid valve delivery system, EVOQUE expander kit, EVOQUE loading system, and various optional accessories. Among them, the EVOQUE valve consists of a 28mm three piece bovine pericardial tissue valve, equipped with a self expanding nickel titanium alloy frame with an anchoring system. This framework can extend between cardiac chordae devices to fix and capture the free edges of native tricuspid valve leaflets (septal, anterior, and posterior). In addition, the valve is equipped with an intrauterine fabric skirt.

03. VADER Pedicle System (ICOTEC AG)
Indications: Restore the integrity of the spine. The VADER pedicle system is designed as an auxiliary means of fusion for stabilizing the thoracic and/or lumbar vertebrae, and is suitable for patients with spinal instability caused by infections (such as discitis, osteomyelitis) or surgical debridement and decompression.

The ADER pedicle system is equipped with its unique BlackArmor ® Composed of carbon fiber reinforced polyether ether ketone composite material. In advanced cancer patients involving thoracic and lumbar vertebrae, even if the patient's expected lifespan before receiving tumor treatment is not sufficient to achieve fusion, this product can restore spinal function within a limited time. The VADER pedicle system can provide surgeons with a minimally invasive and open posterior spinal surgery method.

04. Paclitaxel coated balloon catheter (BOSTON SCIENTIFIC CO.)
Indications: The AGENT paclitaxel coated balloon catheter is suitable for adult patients undergoing percutaneous coronary intervention (PCI) after appropriate vascular preparation. It is used to treat coronary artery lesions with a diameter of 2.0 mm to 4.0 mm and a length not exceeding 26 mm to improve treatment of in stent restenosis (ISR).

05. Ankle joint brace system (4WEB MEDICAL, INC.)
Indications: Ankle joint support system (ATS) is a permanent implant product designed to provide mechanical support for the tibiotalar heel fusion nail, used to assist in the fusion of the tibiotalar heel joint during salvage surgery after failed ankle fusion or ankle replacement surgery, suitable for patients at risk of limb loss.

The ATS device is made of titanium alloy (Ti6Al4V) and has a spherical or cubic structure. This product adopts an open structure bracket design, providing support throughout the implant while also retaining open space to facilitate fusion.

06. Bone Defect Filler (BONE-SUPPORT AB)
Indications: CERAMENT G is an implantable bone defect filler (drug device combination product) used as an adjuvant therapy for systemic antibiotic treatment and surgical debridement (standard treatment for bone infections), suitable for situations requiring supplementary bone transplantation.

This product is composed of hydroxyapatite, calcium sulfate, and gentamicin, and is identical to the product approved by DEN210044. This application has expanded the indications of the product, specifically for use in patients with open fractures who require bone defect filling.

07. tricuspid valve repair system (ABBOTT MEDICAL)
Scope of indications: The TriClip G4 system is designed to reduce tricuspid regurgitation (TR) and repair native tricuspid valves without the need for open chest surgery by grasping and aligning the tricuspid valve leaflets.

This product consists of TriClip Controllable Catheter (SGC), TriClip G4 Delivery System (TDS), and accessories.

08. Vertebral replacement system (ICOTEC AG)
Indications: The KONG-TL system is suitable for thoracolumbar spine (T1 to L5) and is used to replace collapsed, damaged, or unstable vertebral bodies caused by tumors or trauma (such as fractures). The KONG-C system equipment is suitable for cervical vertebrae (C2 to T1) of patients with mature bone development, and is used to replace vertebral bodies that have been affected or damaged due to tumors, fractures, or osteomyelitis, or for reconstruction after vertebral resection surgery to achieve decompression of the spinal cord and nerve tissue in cervical degenerative diseases.

Both devices use BlackArmor with a special titanium coating ® Prepared from carbon fiber reinforced polyether ether ketone.

09. Intervertebral fusion cage system (ICOTEC AG)
Indications: This product is suitable for patients with mature bones who undergo spinal fusion surgery at one or more intervertebral levels (C2-T1).

The icotec interbody fusion system is made of carbon fiber reinforced polyetheretherketone material and has a rough titanium coating. This product series includes one cervical fusion device and two lumbar fusion devices.

10. Everolimus eluting absorbable stent system (ABBOTT MEDICAL)
Indications: Esprit BTK stent is an absorbable polylactic acid stent with drug and absorbable polymer coating, which is absorbed over time. This product is used to treat advanced peripheral arterial disease (PAD) patients with knee artery occlusion or severe limb ischemia (CLI).

The Esprit BTK everolimus eluting absorbable stent system consists of a balloon dilation stent and a delivery system.

11. Anterior Cervical Fixation Plate System (ICOTEC AG)
Indications: The icotec anterior cervical fixation plate system is made of carbon fiber-reinforced polyether ether ketone material with tantalum markings, and is designed specifically for routine anterior cervical surgery.

According to publicly available information, the icotec anterior cervical fixation plate system offers multiple plate lengths and is equipped with self tapping screws to adapt to the specific anatomical structure of patients. The width of the fixed plate is 18 millimeters, and implants with 1 to 4 segments can be selected, with a length range of 21 millimeters to 94 millimeters. The fixed plate is pre bent to fit the patient's anatomical structure, and the screw holes on the plate are conical and threaded.

The self tapping screws of the icotec anterior cervical fixation plate system have two diameters of 4.0mm and 4.25mm, as well as two lengths of 13mm and 15mm. The fully threaded bone screw has a threaded conical head that can be securely locked onto the fixation plate. The conical thread head design of the screw can prevent pulling out, and the angle design of the screw in the cranial direction can prevent the screw from penetrating the lower endplate of the vertebral body.

12. Pelvic fixation implant system (SI-BONE, INC.)
Indications: Mainly used for the fixation of pelvic fractures, including acute, non acute, and non traumatic fractures.

The iFuse TORQ TNT system includes a fully threaded, 3D printed porous implant with optional washers and instruments for placing the implant under fluoroscopy guidance or in conjunction with certain navigation systems. The implant material is titanium alloy, manufactured through 3D printing, and has specific pelvic anatomical characteristics. This device is very similar to its main similar product, the iFuse TORQ implant system, except that it has a longer length (up to 170 millimeters) and a smaller diameter. The longer length allows it to be placed in a trajectory across the ilium and sacrum.

13. Implantable Neuroelectrical Stimulator (NEUROS MEDICAL, INC.)
Indications: The Altius system is an implantable neuroregulatory device designed to manage chronic refractory post amputation pain (PAP) through high-frequency alternating current (HFAC).
The Altius implantable pulse generator (IPG) is used for implantation in the abdomen and can generate HFAC electrical stimulation (5-10 kHz). The electrical stimulation is transmitted to the implanted sleeve electrode of the target nerve through the stimulation wire, which is wrapped around the target nerve near the nerve stump of the amputated leg. Research shows that the entire treatment process lasts only 30 minutes, and patients can freely use the Altius system to treat pain attacks as needed (PRN).

14. Pulmonary artery stent for infants and young children (RENATA MEDICAL, INC.)
Indications: The Minima stent system is suitable for treating primary or acquired pulmonary artery stenosis or aortic constriction in newborns, infants, and children weighing at least 1.5 kilograms.

Minima stent is a symmetrical cobalt chromium (CoCr) stent that can inflate airbags, transmit X-rays. The bracket is sterilized using ethylene oxide gas and pre compressed and installed on the Minima delivery system airbag for packaging. This bracket has a unique unit design that can be re expanded with appropriately sized balloon catheters, up to a maximum diameter of 24 millimeters. However, at the same time, the length of the bracket will decrease, so the specific situation needs to refer to the instructions for use.

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