Abstract: A kit for implantation of an implantable medical device (IMD) comprises an elongated outer shaft, a tether, and an elongated inner shaft. The IMD comprises a fixation element comprising a looped portion. The outer shaft is sized to traverse a vasculature of the patient and defines a longitudinal lumen and a port in fluid communication with the lumen and located proximal a distal end of the outer shaft. A first portion of the tether is configured to pass through the lumen. A second portion of the tether is configured to exit the lumen through the port and pass through the looped portion of the fixation element of the IMD outside of the outer shaft. A third portion of the tether defines a looped portion of the tether. A portion of the inner shaft is configured to pass through the lumen and to pass through the looped portion of the tether.

Abstract: A system includes a delivery catheter and a separately-packaged implantable medical device assembly. The assembly includes a relatively compact implantable medical device, a support shaft, a tether, and a snare mandrel. The tether, which extends in the support shaft, has a distal portion coupled to the device, at a distal end of the support shaft, and a proximal portion protruding from a proximal end of the support shaft, for engagement by a hook of the snare mandrel. An operator may use the engaged snare mandrel to pull the support shaft into a lumen of an inner shaft of the catheter so that the coupled device comes into engagement with a flared end of the catheter inner shaft. Then, after locking the proximal portion of the tether within the catheter, the operator may advance a receptacle of the catheter over the device.

Abstract: A kit for implantation of an implantable medical device (IMD) comprises an elongated outer shaft, a tether, and an elongated inner shaft. The IMD comprises a fixation element comprising a looped portion. The outer shaft is sized to traverse a vasculature of the patient and defines a longitudinal lumen and a port in fluid communication with the lumen and located proximal a distal end of the outer shaft. A first portion of the tether is configured to pass through the lumen. A second portion of the tether is configured to exit the lumen through the port and pass through the looped portion of the fixation element of the IMD outside of the outer shaft. A third portion of the tether defines a looped portion of the tether. A portion of the inner shaft is configured to pass through the lumen and to pass through the looped portion of the tether.

Abstract: A system includes a delivery catheter and a separately-packaged implantable medical device assembly. The assembly includes a relatively compact implantable medical device, a support shaft, a tether, and a snare mandrel. The tether, which extends in the support shaft, has a distal portion coupled to the device, at a distal end of the support shaft, and a proximal portion protruding from a proximal end of the support shaft, for engagement by a hook of the snare mandrel. An operator may use the engaged snare mandrel to pull the support shaft into a lumen of an inner shaft of the catheter so that the coupled device comes into engagement with a flared end of the catheter inner shaft. Then, after locking the proximal portion of the tether within the catheter, the operator may advance a receptacle of the catheter over the device.

Abstract: A system for delivering an implantable medical device includes a loading assembly and a catheter. The loading assembly includes a deployment member and a sidewall defining a chamber into which the device may be pulled through a distal opening thereof, so that the sidewall holds fingers of the device's fixation member in an extended condition while a temperature in the chamber is lowered. When the chamber is connected to the catheter, advancing the deployment member pushes the device, with fixation fingers in the extended condition, into a delivery lumen of the catheter. With the catheter positioned within a patient, the device can be pushed into a distal portion of the catheter while a relatively cold fluid is infused through the delivery lumen. While holding the deployment member in place, retracting the catheter exposes the device fixation fingers out from the lumen, for engagement with tissue at the implant site.

Abstract: A system for delivering an implantable medical device includes a loading assembly and a catheter. The loading assembly includes a deployment member and a sidewall defining a chamber into which the device may be pulled through a distal opening thereof, so that the sidewall holds fingers of the device's fixation member in an extended condition while a temperature in the chamber is lowered. When the chamber is connected to the catheter, advancing the deployment member pushes the device, with fixation fingers in the extended condition, into a delivery lumen of the catheter. With the catheter positioned within a patient, the device can be pushed into a distal portion of the catheter while a relatively cold fluid is infused through the delivery lumen. While holding the deployment member in place, retracting the catheter exposes the device fixation fingers out from the lumen, for engagement with tissue at the implant site.