Spectranetics gets extended approval for laser catheters
This article was originally published in Clinica
The US FDA has approved Spectranetics' Vitesse and Extreme laser angioplasty catheters for use with the Dymer 200+ laser. Vitesse, a rapid-exchange catheter, will be launched immediately but users of the discontinued laser unit will have to wait until the third quarter to obtain Extreme. Spectranetics discontinued production of the Dymer laser when it took over Advanced Interventional Systems in June 1994. Extreme, an over-the-wire device, received FDA approval for use with Spectranetics' own laser system, the CVX-300, in November 1993 and Vitesse was approved a year later.
You may also be interested in...
Perrigo, Pfizer want the US FDA to postpone its March 1 deadline for conducting nitrosamine risk assessments. Generics exec cites“serious compliance challenges” in conducting these assessments due to difficulty in finding the right lab equipment necessary to quantify nitrosamine daily intake limits.
Deal snapshot: For $425m up front, the pharma obtains a Phase III recombination fusion protein that shows ability to improve hospitalized patients’ clinical status and reduce risk of death.
Previous businesses FDA warned about COVID-19 claims for chlorine dioxide, a bleach solution, were marketing dietary supplements unlawfully. But Pro Breath MD's oral rinses available under the Dentist Select and OraCare brands are allowed and FDA isn’t asking the firm to discontinue distribution.