ANALYSIS: Cardiovascular segment takes lion's share of 67 January approvals

A total of 67 product approvals passed Clinica's news desk in January, up from the 50 seen in December and the 47 seen in January 2012.

The January 2013 approvals included:

• 33 510(k) clearances and one expanded 510(k) from the US FDA;
• 3 premarket approvals (PMAs) and 3 PMA supplements from the US FDA;
• 2 new drug approvals (NDAs) from the US FDA;
• 1 US FDA de novo approval;
• 18 CE marks in the EU;
• 2 Health Canada approvals;
• 2 Japanese approvals;
• 1 Roszdravnadzor approval in Russia.

• The NDAs were in the field of drug delivery: NuPathe's Zecuity battery-powered transdermal migraine patch; and Bayer HealthCare's Skyla intrauterine contraceptive device, which the firm claims is the first new IUD to be approved in 12 years and delivers a lower dose of levonorgestrel than rival devices.

• The two products to clear Japan's notoriously high regulatory hurdles were Spectranetics' Quick-Cross support catheter for use in interventions for peripheral artery disease; and Alphatec Spine's spinal spacers Novel SD, Novel LCC, Novel TL, which are used in the treatment of spinal stenosis.

• The Russian approval was for FzioMed's Oxiplex viscoelastic gel, which is applied during lumbar spine surgery immediately prior to wound closure, and which the firm claims significantly reduces the effects of failed back surgery syndrome.

• The de novo approval was for Resonance Health's FerriScan R2-MRI, which was approved as an imaging companion diagnostic for use with Novartis's Exjade (deferasirox) in the treatment of non-transfusion-dependent thalassaemia. FerriScan was previously approved to measure liver iron concentration.

• Other notable approvals include the EU green light for Lilly's amyloid imaging agent Amyvid, which is used to help rule out Alzheimer's disease (www.clinica.co.uk, 16 January 2013). The product has been approved in the US since last April (www.clinica.co.uk, 12 April 2012). Lilly's closest rival in the Alzheimer's imaging market is GE Healthcare with ¹⁸F flutemetamol – GE filed its agent with both the US and European regulatory authorities in January and expects approval by the end of the year, so it is still some way behind Lilly.

• The cardiovascular segment saw the majority of approvals, with 17, including Direct Flow Medical's Transcatheter aortic valve system, which received the CE mark. Clinica had previously predicted the approval of the device (www.clinica.co.uk, 13 December 2012), which "virtually eliminates aortic regurgitation", unlike other TAVI devices, according to Direct Flow CEO Bernard Lyons.

• Clinica recorded seven approvals apiece in imaging and in vitro diagnostics, and five in orthopaedics.

See Clinica's Approvals Table for more details of all the recorded approvals in January and beyond.