2012 could see US innovative device approvals grow

This year is on course to see more US premarket approvals (PMAs) granted for medical devices than 2011, according to EvaluateMedTech data. Because PMAs are granted for the most complex and innovative devices, it appears that 2012 could be an impressive year for new medical technologies.

In 2011, 38 medical technologies were awarded PMAs; so far this year, 28 have attained this standard. But nearly a third of the 2011 total were approved in the final quarter; if approvals are granted this year at the same rate as they were last year, 2012 would see a further 13 PMAs, meaning that the year-end total would reach 41, an 8% increase on 2011. However, should the third quarter of 2012 see the equivalent of the average number for the other three quarters of 2012 – nine – 2012 will equal 2011’s tally.

Testing times

Premarket approval is the process used to evaluate Class III medical devices – those that are vital to sustaining life or preventing impairment of health, or those that are themselves potentially dangerous. PMA is more rigorous than the more common US device approval pathway, premarket notification, also called a 510(k) clearance, in which a device must only be proven equivalent to an already marketed predicate.

Device type  PMAs 2011  PMAs 9mth 2012
Cardiac Prosthetic Devices 3 1
Cardiac Rhythm Management 1 1
Cardiovascular Surgical Devices 2 0
Computed Tomography 1 0
Electrophysiology 1 1
Gastrointestinal Therapeutic Devices 0 1
Histology & Cytology 0 1
Immunoassays 8 5
Infusion Systems 0 1
Interventional Cardiology 6 6
Joint Reconstruction 1 0
Molecular Diagnostics 7 3
Neurology Therapeutic Devices 2 0
Nose Devices 1 0
Ophthalmic Prosthetic Devices 0 1
Ophthalmic Surgical Devices 0 1
Orthobiologics 1 0
Other Diagnostic Imaging 0 2
Spinal Devices 0 1
Surgical Instruments & Accessories 1 0
Surgical Prosthetic Devices 1 1
Urinary Incontinence Devices 2 0
Unclassified 0 2
Total 38 28

A glance at the table above shows that the standout areas for approvals in both years were diagnostics and cardiology.

Roche dominated the immunoassays segment in 2011, with its Elecsys equipment, used to diagnose hepatitis B, making up four of the eight PMAs awarded. These assays detect IgM antibodies to hepatitis B core antigen in human serum or plasma. In 2012, though, the picture was more varied, and only one PMA was granted for a Roche immunoassay; the other four approvals went to diagnostics from Siemens, Otsuka, Abbott and Danaher.

A similar downward trend was seen in molecular diagnostics – although this could be reversed in the final quarter. Seven PMAs were won by molecular diagnostic tests last year, compared with just three so far in 2012.

Perhaps the most interesting of those approved in 2011 is Abbott’s Vysis ALK test, a companion diagnostic designed to identify a subset of patients with advanced non-small cell lung cancer who could benefit from Pfizer’s Xalkori. The test detects rearrangements of the anaplastic lymphoma kinase (ALK) gene; Xalkori is indicated for the treatment of patients with ALK-positive NSCLC.

Selected FDA premarket approvals – 2011
Approval date Therapy area EvaluateMedTech device classification Device name Company
08 February 2011 Cardiac Rhythm Management Pacemakers Revo MRI Surescan IPG and pacing system Medtronic
26 August 2011 Molecular Diagnostics Oncology Molecular Diagnostics Vysis ALK break apart FISH probe kit Abbott Laboratories
01 November 2011 Interventional Cardiology Drug-Eluting Coronary Stents Xience Prime and Xience Prime LL everolimus-eluting coronary stent system Abbott Laboratories
22 November 2011 Interventional Cardiology Drug-Eluting Coronary Stents Promus Element Plus everolimus-eluting platinum chromium coronary stent system Boston Scientific
14 December 2011 Immunoassays Viral Immunoassays Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgM for use on the Modular Analytics E170 Immunoassay Analyzer Roche

The approval of OraSure Technologies’ OraQuick HIV test, which can be used at home, is another significant breakthrough. This was approved in July 2012 and is the only oral fluid over-the-counter HIV test approved in the US. It detects antibodies to both HIV-1 and HIV-2 with an oral swab and provides results in 20 minutes.

Interventional cardiology has also been a hotbed of activity, with new drug-eluting stents reaching the US market. Abbott’s everolimus-eluting Xience Prime, approved in November 2011, is a new iteration of its market-leading Xience V device. In 2011, sales for the entire Xience franchise were around $1.5bn, EvaluateMedTech data show. On November 22 the agency approved Boston Scientific’s rival device, Promus Element Plus. These two products use the same drug-polymer combination, and differ only in the design of the metal stent itself. Boston also gained a PMA for its Ion paclitaxel-eluting coronary stent.  

In 2012 it was Medtronic’s turn, with approval for its Resolute Integrity stent coming in February. The zotarolimus-coated device is made from a single strand of wire, which is intended to make it easier to deliver and function.

Selected FDA premarket approvals – 2012
Approval date Therapy area EvaluateMedTech device classification Device name Company
03 January 2012 Immunoassays Viral Immunoassays Elecsys Anti-HBc IgM Immunoassay and Elecsys PreciControl Anti-HBc IgM Roche
25 January 2012 Electrophysiology Cardiac Ablation Catheters Therapy Cool Path Duo ablation catheter/Safire BLU duo ablation catheter and the IBI 1500T9-CP V1.6 cardiac ablation generator St. Jude Medical
17 February 2012 Interventional Cardiology Drug-Eluting Coronary Stents Resolute integrity zotarolimus-eluting coronary stent system Medtronic
03 July 2012 Molecular Diagnostics Infectious Disease Molecular Diagnostics OraQuick in-home HIV test OraSure Technologies
28 September 2012 Cardiac Rhythm Management (CRM) Implantable Cardioverter Defibrillators (ICD) Subcutaneous implantable defibrillator (S-ICD) system Boston Scientific

Shock of the new

Cardiac rhythm management saw one new product approved in 2011 and another in 2012; both were genuine advances. Last year, the Revo MRI Surescan developed by Medtronic became the first pacemaker in the US that does not have to be removed when the patient requires an MRI scan.

And this September saw the approval of Boston Scientific’s new subcutaneous implantable cardioverter-defibrillator (S-ICD), which is unlike any other device on the market in that the pacing leads are implanted subcutaneously, rather than threaded through the vasculature to reach the heart. Analysts from Credit Suisse estimate that the device will increase Boston Scientific’s share of the worldwide ICD market by around 2%, or $140m (EP Vantage Interview – Boston Scientific remakes itself to face the future, October 22, 2012).

If 2012 sees the same kind of tail-end jump in approvals as 2011 it could be a bumper year for medtech.

To contact the writer of this story email Elizabeth Cairns in London at elizabethc@epvantage.com

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