FDA approves implantable therapy for PAH

 

The Food and Drug Administration announced Dec. 22, 2017, that it has approved an implantable system for treprostinil to treat adult patients with New York Heart Association (NYHA) Class I, II and III pulmonary arterial hypertension.

This infusion system is implanted into a patient for intravenous delivery of treprostinil (Remodulin) and is designed to help supply blood to the lungs and keep a patient’s blood pressure within a healthy range. The system comprises three parts: the pump, the programmer, and the catheter.

The Medtronic 8201 Implantable 80 cm Intravascular Catheter is inserted through a vein at the superior cavoatrial junction and connects the catheter to the Medtronic SynchroMed II 8637P Programmable Pump in a pump pocket placed beneath the abdominal skin. Then, the surgeon uses the Medtronic N’Vision 8840 Clinician Programmer with 8870 Application Card to program and review the pump’s settings. Once programmed, the implantable system delivers the Remodulin injection from the pump reservoir, through the pump tubing, the catheter port, and the catheter to the intravascular delivery site. Finally, the pump stays permanently implanted and the health care provider uses a needle and syringe refill kit to refill the pump with Remodulin, as needed.

The implant should not be used for patients with NYHA Class IV heart failure, a known or suspected infection, bacteremia, or sepsis requiring antibiotics; vasculature that is inadequate for an 8 French introducer or catheter advancement without stylet guidance; implanted leads or catheters (active or abandoned) in the superior vena cava that cannot be removed prior to or at system implant; a body size not sufficient to accept the pump; or skin or soft tissue that would heal poorly or increase susceptibility to infections. Patients who are unable to tolerate a sudden cessation of treprostinil therapy also would not be able to receive the implantable device.

Read the full approval on the FDA’s website.

llaubach@frontlinemedcom.com

 

The Food and Drug Administration announced Dec. 22, 2017, that it has approved an implantable system for treprostinil to treat adult patients with New York Heart Association (NYHA) Class I, II and III pulmonary arterial hypertension.

This infusion system is implanted into a patient for intravenous delivery of treprostinil (Remodulin) and is designed to help supply blood to the lungs and keep a patient’s blood pressure within a healthy range. The system comprises three parts: the pump, the programmer, and the catheter.

The Medtronic 8201 Implantable 80 cm Intravascular Catheter is inserted through a vein at the superior cavoatrial junction and connects the catheter to the Medtronic SynchroMed II 8637P Programmable Pump in a pump pocket placed beneath the abdominal skin. Then, the surgeon uses the Medtronic N’Vision 8840 Clinician Programmer with 8870 Application Card to program and review the pump’s settings. Once programmed, the implantable system delivers the Remodulin injection from the pump reservoir, through the pump tubing, the catheter port, and the catheter to the intravascular delivery site. Finally, the pump stays permanently implanted and the health care provider uses a needle and syringe refill kit to refill the pump with Remodulin, as needed.

The implant should not be used for patients with NYHA Class IV heart failure, a known or suspected infection, bacteremia, or sepsis requiring antibiotics; vasculature that is inadequate for an 8 French introducer or catheter advancement without stylet guidance; implanted leads or catheters (active or abandoned) in the superior vena cava that cannot be removed prior to or at system implant; a body size not sufficient to accept the pump; or skin or soft tissue that would heal poorly or increase susceptibility to infections. Patients who are unable to tolerate a sudden cessation of treprostinil therapy also would not be able to receive the implantable device.

Read the full approval on the FDA’s website.

llaubach@frontlinemedcom.com

 

The Food and Drug Administration announced Dec. 22, 2017, that it has approved an implantable system for treprostinil to treat adult patients with New York Heart Association (NYHA) Class I, II and III pulmonary arterial hypertension.

This infusion system is implanted into a patient for intravenous delivery of treprostinil (Remodulin) and is designed to help supply blood to the lungs and keep a patient’s blood pressure within a healthy range. The system comprises three parts: the pump, the programmer, and the catheter.

The Medtronic 8201 Implantable 80 cm Intravascular Catheter is inserted through a vein at the superior cavoatrial junction and connects the catheter to the Medtronic SynchroMed II 8637P Programmable Pump in a pump pocket placed beneath the abdominal skin. Then, the surgeon uses the Medtronic N’Vision 8840 Clinician Programmer with 8870 Application Card to program and review the pump’s settings. Once programmed, the implantable system delivers the Remodulin injection from the pump reservoir, through the pump tubing, the catheter port, and the catheter to the intravascular delivery site. Finally, the pump stays permanently implanted and the health care provider uses a needle and syringe refill kit to refill the pump with Remodulin, as needed.

The implant should not be used for patients with NYHA Class IV heart failure, a known or suspected infection, bacteremia, or sepsis requiring antibiotics; vasculature that is inadequate for an 8 French introducer or catheter advancement without stylet guidance; implanted leads or catheters (active or abandoned) in the superior vena cava that cannot be removed prior to or at system implant; a body size not sufficient to accept the pump; or skin or soft tissue that would heal poorly or increase susceptibility to infections. Patients who are unable to tolerate a sudden cessation of treprostinil therapy also would not be able to receive the implantable device.

Read the full approval on the FDA’s website.

llaubach@frontlinemedcom.com