Interventional cardiology devices are designed to treat, through minimally invasive procedures, coronary artery diseases. In this area the main device is the stent, a small expandable wire tube that is placed in an occluded coronary artery to remove the plaque and support the walls of the vessel, thus enabling the blood to flow properly.

Bare metal stents (BMS) and drug eluting stents (DES) are two separate product markets for the following reasons: no significant price correlation, no supply side substitutability, very significant differences in clinical outcomes, and different reimbursement systems. Moreover, despite the fact that BMS and DES share the same stent structure and delivery system, a number of components are specifically important to a coronary DES (the drug, drug dosage and rate of release, and polymer coatings).

Concerning the accessories coronary guiding catheters, coronary steerable guidewires, coronary PTCA balloon catheters, the Commission’s market inquiry has established that each of these products constitutes a separate relevant product market. Most interventions will require a specific set of accessories, with different dimensions and shape.

Endovascular devices are used for the minimally invasive treatment of peripheral vascular (or endovascular) diseases such as the build up of plaque (i.e. vessel calcification) in peripheral vessels (peripheral arterial disease) and aneurysm (the enlargement of a weak area of an artery).

Similar to interventional cardiology stents, endovascular stents are small expandable tubes designed to treat a narrowing or blockage in a peripheral artery.

The parties submitted, and the Commission’s market inquiry confirmed, that two separate markets should be identified for endovascular stents: a market for balloon expandable stents (BX) (usually made of stainless steel and which come mounted on a PTA balloon catheter), and a market for self-expandable stents (SX), which use a different deployment technology. The Commission inquiry established a clear trend towards more specialisation in the endovascular area, both for BX stents (e.g. segments for renal (BX) stents and for iliac-femoral (BX) stents) and for SX stents (e.g. segments for femoral (SX) stents, iliac (SX) stents and carotid stents).

As far as the accessories are concerned, endovascular guiding catheters, steerable guidewires and PTA balloon catheters perform a similar function to the corresponding products in interventional cardiology. Similarly to the coronary area, a relevant market should be defined for each of these accessories, due to the high degree of supply side substitutability and the fact that all major manufacturers offer, within each accessory, a very broad range of models in terms of dimensions and shapes.

Coronary artery bypass graft surgery (CABG) is used to treat coronary artery disease; the blocked artery is ‘bypassed’ by sewing (grafting) another blood vessel to the aorta at one end and to the coronary artery beyond the damaged area the other end. After the operation, blood flows through the new grafted vessel to the heart muscle. The vessel used for the bypass is removed (harvested) from the leg (saphenous vein graft), chest or arm.

The following markets are affected in the cardiac surgery area: (i) beating-heart CABG products (stabilisation systems and accessories as blowers/misters); and (ii) endoscopic vessel harvesting (EVH) devices.