Important Safety Information

The Prometra Il Programmable Pump system delivers medication directly to the fluid-filled space of tissue around the spinal cord for the treatment of chronic pain and spasticity.

Targeted drug delivery should be considered after you have tried oral medications or other therapies and they have not worked, or you cannot tolerate them.

The use of an implanted Prometra Programmable Pump system provides an important means of treating patients. However, the potential exists for serious complications and risks similar to any surgical procedure. Pump or catheter problems can occur after implantation which may require corrective surgery and/or cause a drug overdose that may be life-threatening. Drugs infused through the system may result in adverse events.

Not everyone responds to targeted drug delivery the same way and your experience may vary. To understand the benefits and risks of targeted drug delivery, please discuss them in detail with your physician. A prescription is required.

Please see links for Brief Statements of Important Safety Information below:

Brief Statement for US Consumers. PL-19701-04.

Brief Statement for US Healthcare Professionals. PL-19589-04.