News and future development in the United States and Canada
February 6, 2007
The Canadian application for Medical Device License has been submitted, and
we are awaiting response by mid February.
January 15, 2006
On December 12, 2005, the FDA Office of Orphan Products Development has decided that the HUD designation cannot be granted to the device on the base that “…PAP Device Asklipios Model could be a safer alternative to surgery in medically refractory epilepsy patients, we feel that the number of patients who would be eligible for treatment with the device is more than 4000…”
Although this decision is a setback for having the device available to refractory epilepsy patients, it is very encouraging that the FDA believes that the PAP Device Asklipios Model could be a safer alternative to surgery in medically refractory epilepsy patients.
We are analyzing the alternatives we have to apply for an IDE in this indication and will make the application available as soon as possible.
September 26, 2005
PulseDynamics
had applied through its regulatory consultants in the
The PAP DEVICE Asklipios Model is intended to be used to help control symptoms of refractory epilepsy that fails to respond to any known treatment both surgical and pharmacological.
September
6, 2005
PulseDynamics
had applied through its regulatory consultants in the
The PAP DEVICE Asklipios Model is intended to be used to help control symptoms of Friedrich ataxia (muscular weakness and unsteadiness) as part of a complete physical and general therapy of the individuals affected by the disease.
June 18, 2005
Dr. Panos Pappas, sponsor of a clinical study titled “A Pre-clinical Study to Evaluate the PAP Ion Magnetic Inductor Device in the Management of Myalgias and Arthralgias complied with and FDA order to suspend the clinical trial and stop enrolment. The main reason was that the FDA reclassified the device according to their regulations and guidelines making the clinical trial process more stringent.
August 12, 2005
The FDA acknowledges receipt of compliance letter and suspension of the study.
August 23, 2005
A new manufacturer, PulseDynamics Manufacturing Company, located in Athens Greece obtained license to manufacture the PAP IMI type device.
The new manufacturer is going to build two different models of the device;
- PAP DEVICE Asklipios Model for Human Use and
- the PAP Device Heraklitos model for veterinary use only.
PulseDynamics decided to start the development of the device in Canada and the US and is in the process to apply for an IDE (Investigational Device Exemption).
The title of the clinical study will be “Clinical Study to Evaluate Safety and Efficacy of the Pap ion magnetic inductor in the treatment of Myalgias and Arthralgias”.
Investigators interested to participate in that trials please visit our page Clinical Trials with the PAP DEVICE Asklipios Model for Human Use.
August 25, 2005
PulseDynamics decided to apply for an HUD (Humanitarian Use Designation) to obtain marketing authorization of the PAP DEVICE Asklipios Model for Human Use for the following indication: to help control symptoms of Friedreich Ataxia (muscular weakness and unsteadiness) in patients where the disease was confirmed by genetic testing, as part of a complete physical and general therapy. Please check the page HUD – Friedreich Ataxia for more information.
August 26, 2005
PulseDynamics decided to apply for an HUD (Humanitarian Use Designation) to obtain marketing authorization of the PAP DEVICE Asklipios Model for Human Use for the following indication: concomitant therapy for unsatisfactory controlled seizures refractory to all antiepileptic drugs and surgery. Please check the page HUD – uncontrolled seizures for more information.
August 30, 2005
Pulse Dynamics has the PAP Device Heraklitos model for veterinary use only already available for sale in the United States and Canada. This device does not need a license or regulatory approval since it is for veterinary use only. Please contact us for more information and visit the page PAP Device Heraklitos model for veterinary use only
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