An implantable venous port is a special intravenous (IV) line that is completely inside the body. It consists of a port, which is a round piece of metal with a soft, silicone top the size of a quarter, and a catheter, which is the thin, flexible tube attached to the port.

Some medications cannot be given through regular IV lines and some require frequent, painful needle insertions. A port provides a more comfortable way  for your child to receive IV nutrition and fluids, as well as medications such as chemotherapy. A port also allows the medical team to obtain blood samples more easily. To give medicines or take blood, we insert a needle through the skin into the port. We usually put numbing cream on the skin, so your child will not feel pain.

Using ultrasound and live X-ray (fluoroscopy) for guidance, an interventional radiologist will insert the catheter into an access vein, usually in the neck. (Sometimes we use veins in the arm or upper leg.)

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators are used during spinal fusion surgery to increase the possibility of permanently connecting two or more bones of the spine (backbone) together. The device is implanted into the patient's back and provides constant electrical stimulation to the surgical site.

Zimmer Biomet is recalling the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs (cytotoxicity) and that were found during the company's routine monitoring procedure. A cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body. A positive cytotoxicity test (failed result) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient.

An implantable venous port is a special intravenous (IV) line that is completely inside the body. It consists of a port, which is a round piece of metal with a soft, silicone top the size of a quarter, and a catheter, which is the thin, flexible tube attached to the port.

Some medications cannot be given through regular IV lines and some require frequent, painful needle insertions. A port provides a more comfortable way  for your child to receive IV nutrition and fluids, as well as medications such as chemotherapy. A port also allows the medical team to obtain blood samples more easily. To give medicines or take blood, we insert a needle through the skin into the port. We usually put numbing cream on the skin, so your child will not feel pain.

Using ultrasound and live X-ray (fluoroscopy) for guidance, an interventional radiologist will insert the catheter into an access vein, usually in the neck. (Sometimes we use veins in the arm or upper leg.)

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators are used during spinal fusion surgery to increase the possibility of permanently connecting two or more bones of the spine (backbone) together. The device is implanted into the patient's back and provides constant electrical stimulation to the surgical site.

Zimmer Biomet is recalling the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs (cytotoxicity) and that were found during the company's routine monitoring procedure. A cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body. A positive cytotoxicity test (failed result) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient.

Last week we performed the first human implant of the new OPTIMIZER Smart IPG intended for the treatment of Chronic Heart failure in patients that are symptomatic despite appropriate medical treatment.


The first implant of the Optimizer Smart was performed by Dr. Markus Reinartz (left in picture above) at the Herz-Jesu Hospital in Dernbach, Germany. The device’s new, two-lead configuration enables an easier and faster implantation procedure.

Notes:
• The OPTIMIZER Smart System is not currently available in the US. The OPTIMIZER IVs System is currently an Investigational Device in the US.
• I am the Executive VP of Product Development at Impulse Dynamics. However, the statements and opinions expressed in this blog are my own and do not necessarily represent those of my employer.
• This blog post is not intended to act as an advertisement for Impulse Dynamics or its products.

Clinical trials for the implantable artificial kidney haven’t started yet, but the device’s developers are already seeking feedback from patients. The device, currently in preclinical trials, uses microchip filters and living kidney cells that would be powered by a patient’s own heart. It is being developed by the Kidney Project , a collaboration between the University of California at San Francisco and Vanderbilt University. In March, they announced a partnership with Home Dailyzors United (HDU), who will help provide education and support to patients, as well as seek feedback on preferences.

“The Kidney Project is really interested in the patient voice, they want the patient perspective,” said Nieltje Gedney, vice president of HDU. She and HDU president Denise Eilers first met UCSF bioengineer Shuvo Roy, PhD, technical director of the project, at a Kidney Health Initiative meeting.

“When I first met them, I was struck by their passion for improving the outcomes of home dialysis patients,” said Roy. Working with them seemed like a natural move as they began looking for input from patients, he said.

An implantable venous port is a special intravenous (IV) line that is completely inside the body. It consists of a port, which is a round piece of metal with a soft, silicone top the size of a quarter, and a catheter, which is the thin, flexible tube attached to the port.

Some medications cannot be given through regular IV lines and some require frequent, painful needle insertions. A port provides a more comfortable way  for your child to receive IV nutrition and fluids, as well as medications such as chemotherapy. A port also allows the medical team to obtain blood samples more easily. To give medicines or take blood, we insert a needle through the skin into the port. We usually put numbing cream on the skin, so your child will not feel pain.

Using ultrasound and live X-ray (fluoroscopy) for guidance, an interventional radiologist will insert the catheter into an access vein, usually in the neck. (Sometimes we use veins in the arm or upper leg.)

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

The Zimmer Biomet SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators are used during spinal fusion surgery to increase the possibility of permanently connecting two or more bones of the spine (backbone) together. The device is implanted into the patient's back and provides constant electrical stimulation to the surgical site.

Zimmer Biomet is recalling the SpF PLUS-Mini and SpF XL IIb Implantable Spinal Fusion Stimulators due to higher than allowed levels of potential harmful chemicals, which may be toxic to tissues and organs (cytotoxicity) and that were found during the company's routine monitoring procedure. A cytotoxicity test is a part of the biological evaluation of medical devices to ensure compatibility with the device and the human body. A positive cytotoxicity test (failed result) can indicate that a device contains potential harmful chemicals at amounts or levels that could be dangerous to the patient.

Last week we performed the first human implant of the new OPTIMIZER Smart IPG intended for the treatment of Chronic Heart failure in patients that are symptomatic despite appropriate medical treatment.


The first implant of the Optimizer Smart was performed by Dr. Markus Reinartz (left in picture above) at the Herz-Jesu Hospital in Dernbach, Germany. The device’s new, two-lead configuration enables an easier and faster implantation procedure.

Notes:
• The OPTIMIZER Smart System is not currently available in the US. The OPTIMIZER IVs System is currently an Investigational Device in the US.
• I am the Executive VP of Product Development at Impulse Dynamics. However, the statements and opinions expressed in this blog are my own and do not necessarily represent those of my employer.
• This blog post is not intended to act as an advertisement for Impulse Dynamics or its products.

An implantable venous port is a special intravenous (IV) line that is completely inside the body. It consists of a port, which is a round piece of metal with a soft, silicone top the size of a quarter, and a catheter, which is the thin, flexible tube attached to the port.

Some medications cannot be given through regular IV lines and some require frequent, painful needle insertions. A port provides a more comfortable way  for your child to receive IV nutrition and fluids, as well as medications such as chemotherapy. A port also allows the medical team to obtain blood samples more easily. To give medicines or take blood, we insert a needle through the skin into the port. We usually put numbing cream on the skin, so your child will not feel pain.

Using ultrasound and live X-ray (fluoroscopy) for guidance, an interventional radiologist will insert the catheter into an access vein, usually in the neck. (Sometimes we use veins in the arm or upper leg.)

Pacemakers and Implantable Defibrillators | MedlinePlus


The World of Implantable Devices - A blog about what is.

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