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ANALYSIS: Medtronic tops approvals charts as 2014 sees volume jump

This article was originally published in Clinica

Executive Summary

A total of 77 approvals passed Clinica's news desk in December, a substantial increase from the 58 recorded in December 2013 and 43 in November 2014.

This helped boost the total number of 2014 approvals to 793, compared with 755 overall in 2013.

The December 2014 approvals, split by geography, are shown in Table 1, below:

Table 1. December 2014 approvals by geography

Geography

Number of approvals in December 2014

Americas

US

37 510(k) clearances, 3 PMAs, 1 de novo, 1 emergency use authorization, 1 humanitarian device exemption, 3 CLIA waivers, 2 OTC clearances, 8 unknown

Canada

2 Health Canada approvals

EU

15 CE marks

Asia-Pacific

China

3

Korea

3

An important indicator of true innovation entering the market is the number of US FDA premarket approvals (PMAs), a route usually taken by technologies for which there is no precedent or for high-risk devices. In December, there were three PMAs. Two went to Cerus, for its INTERCEPT Blood System for plasma and INTERCEPT Blood System for platelets. The devices are used to prepare donated plasma or platelets to reduce the risk of transfusion-transmitted infection.

The other PMA was for Medtronic's S-shape and Straight Attain Performa left ventricular quadripolar leads, for use with cardiac resynchronization therapy defibrillators. See Table 2 for more details.

Table 2. FDA PMAs in December

Company

Product name

Product description

Indication

Date reported

Cerus

INTERCEPT Blood System for plasma

Blood system

Preparation of plasma to reduce the risk of transfusion-transmitted infection

16/12/14

Cerus

INTERCEPT Blood System for platelets

Blood system

Preparation of platelets to reduce the risk of transfusion-transmitted infection

18/12/14

Medtronic

Attain Performa S-shape and Straight

Left ventricular quadripolar leads

For use with cardiac resynchronization therapy defibrillators for heart arrhythmias

11/12/14

In 2014 overall, Clinica recorded 29 PMAs and 13 PMA supplements; versus 27 PMAs and 23 PMA supplements in 2013.

Going back to December 2014, the approvals by type are shown in Figure 1, below.

Figure 1.

After seeing the cardiovascular sector on top for most of 2014, in vitro diagnostics (IVDs) topped the approvals chart in December, with 23 approvals, followed by cardiovascular in second place with 16. See Figure 2 for more details.

Figure 2.

This echoed the trend seen all year, when the two segments have vied for the top spot. Cardiovascular products were the most frequently approved in in January, February, March, April (in joint first place with imaging), July, August, September and November; while IVDs took the crown in May, June, October and December.

No other sector got close. Over the whole of 2014, Clinica tracked 140 IVD approvals and 137 cardiovascular approvals. The next most popular market was imaging, with 84.

Roche tops December list but Medtronic is 2014 leader

The company with the most approvals in December was Roche, with five: it got US emergency use authorization for its Ebola diagnostic, the LightMix Ebola Zaire rRT-PCR Test; and CE marked its CMV (cytomegalovirus) viral load assay, and cobas HCV (hepatits C), and cobas HIV-1 tests. In addition, it reported an expanded CE mark for its cobas MPX and WNV tests (for testing human organ and tissue from cadaveric donors for various viruses and West Nile virus, respectively).

As for the most-approved companies in 2014, somewhat predictably this list was led by the biggest pureplay medtech firm (and number three overall player) Medtronic, with 32 approvals. The company has been a big spender when it comes to buying in innovation, and has also invested heavily in R&D, plowing in $1.56bn in 2013 and $1.48bn in 2014, according to this year's Clinica 100. In contrast, number-four company Siemens Healthcare spent $1.23bn on R&D in 2013.

Some way behind was second-placed Boston Scientific, with 20 approvals, followed by Covidien (soon to become part of Medtronic) with 16 approvals. See Figure 3 for more details.

Figure 3.

2013 also told a similar story, with Medtronic bagging the most approvals, 29, Boston second, with 20, and St Jude third, with 16.

Notable December approvals

Other notable approvals in December 2014 included:

  • CE marking for 23andMe's Personal Genome Service, which the California company has now launched in the UK. The test was banned by the US FDA in November 2013 when the regulator said 23andMe failed to provide adequate information to back up claims about the results;
  • US approval for Myriad Genetics' BRACAnalysis CDx companion diagnostic for use with AstraZeneca's Lynparza (olaparib) in ovarian cancer. Read more details in an exclusive interview with the company;
  • US approval for Johnson & Johnson's Animas Vibe insulin pump and continuous glucose monitoring system, giving US patients a second option for a pump and CGM integrated device (other than Medtronic's MiniMed 530G with Enlite);
  • US 510(k) approval for a new use for NxStage Medical's System One device: home nocturnal hemodialysis. The firm claims it is the first and only hemodialysis machine cleared by the FDA for this indication;
  • US de novo approval for HeartFlow's noninvasive FFR CT technology, computed tomography-based coronary fractional flow reserve software. It is used to assess the severity of blood flow blockages and therefore whether vessels need stenting;
  • US humanitarian device exemption (HDE) for CVRx's Barostim neo legacy neuromodulation device for drug-resistant hypertension; the device activates the patient's baroreceptors to regulate blood flow;
  • CE mark for Optomeditech's OptiVein needle guidance system. The company was featured in Clinica's MedTech Ventures in October 2013;
  • Chinese approval for Epigenomics' Epi proColon colorectal cancer blood test. The company had a setback in June with a "not approvable," letter from the FDA asking for more data on the test;
  • Korean FDA approval for Alpinion's Alpius 900 high-frequency ultrasound device for the treatment of uterine fibroids. Alpinion told Clinica it was hoping to get additional approvals in other countries, but would not give more details as it has not yet finalized its plans.

See Clinica's Approvals Tracker for more details of all the recorded approvals in December and previously.

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