With the FDA approval of Medtronic’s second-generation MRI-friendly pacemaker, the market is finally maturing. The Advisa DR MRI SureScan builds on the same company’s Revo device, which got the nod two years ago.
It is considered unsafe for patients with standard pacemakers to undergo MRI imaging as the strong magnetic field in the scanners can cause the devices to malfunction. The majority of pacemaker recipients are likely to require an MRI scan at some point, and with the population ageing, demand will grow. Medtronic has the US market to itself for now, but the pivotal trial of St Jude Medical’s Accent MRI device is due to read out in March next year, and then things could start moving very quickly.
The Advisa is an advance on the Revo, Medtronic says, because it has improved battery life and higher upper tracking rates, which allow faster heart rates for when people exercise. More than 100,000 Revo devices have been sold worldwide, the Minnesota company says, and it estimates that more than 10% of patients implanted with it have received MRIs. The Revo is priced at between $5,000 and $10,000 apiece, with the cost of the surgical procedure on top.
Sales of MRI-compatible pacemakers hinge on reimbursement, not of the devices themselves – although Revo is covered – but of the MRI scans. The Centres for Medicare and Medicaid Services has long refused Medicare coverage for MRI imaging of patients with pacemakers. However, in July 2011 it decided to allow the procedure “when the pacemakers are used according to the FDA-approved labelling for use in an MRI environment”. This is a huge argument in favour of the use of MRI-compatible pacemakers.
St Jude Medical will probably be Medtronic’s first challenger in the US. The US trial of its Accent pacemaker is enrolling 800 patients; Medtronic’s Advisa MRI won its approval based on data from a trial in just 156 people. If all goes well, the device could reach market by 2015.
As usual, the regulatory environment is easier, and the competition is tougher, in Europe. Medtronic’s ever-present rivals St Jude and Boston Scientific are both in the race, but oddly enough the relative minnow Biotronik beat both those firms to take silver to Medtronic’s gold, CE marking its Evia pacemaker in 2010.
The private German company’s Evia pacemaker incorporates a technology called ProMRI, which permits MRI scans under specific conditions. As with Medtronic’s devices, the Evia allows remote monitoring of patients. It has also set its sights on the US, gaining FDA approval to start a 245-patient trial of the Entovis pacing system, which also uses the ProMRI tech. Initial results are expected in January; Biotronik is in with a shot at beating St Jude to the US market, just as it did in Europe.
The laggard is Boston Scientific. Its Ingenio and Advantio pacemakers, approved in Europe in April 2012, have been adapted to ensure they are compatible with MRI scanning and were CE marked for this use last July.
The devices are designed to treat a particular form of bradycardia called chronotropic incompetence, in which the heart is unable to regulate its beating when the patient undergoes physical activity. Chronotropic incompetence affects around 42% of pacemaker patients, Boston says.
The complex nature of these devices means they can only be developed by multibillion-dollar multinationals; this is not an area in which a start-up can hope to make a dent. Companies with the wherewithal to enter the fray ought to find it worthwhile, though: demographic and economic factors look likely to favour these devices, and the market is set to grow.
|MRI-compatible pacemakers on the market|
|Company||Device name||FDA approval||
|Company pacemaker sales (US$m)*|
|Medtronic||Revo MRI SureScan||February 8, 2011||September 1, 2008||1,978||1,829|
|Medtronic||Advisa DR MRI SureScan||February 14, 2013||June 19, 2009||1,978||1,829|
|Biotronik||Evia ProMRI||-||June 15, 2010||367||471|
|St Jude Medical||Accent MRI||-||April 18, 2011||1,210||1,062|
|Boston Scientific||Ingenio MRI||-||July 27, 2012||569||500|
|Boston Scientific||Advantio MRI||-||July 27, 2012||569||500|
|*NB: sales are for all pacemakers as the companies do not break down their sales by individual devices.|