Top ten: upcoming products to benefit the heart

GlobalData analyst Anju Antony reveals the ten most innovative cardiovascular devices currently in the development pipeline.


1. Absorb bioresorbable vascular scaffold - Abbott

Abbott's Absorb is a bioresorbable, everolimus-eluting, stent that is intended for use during interventional cardiac procedures to treat coronary artery diseases. Using a biodegradable polymer bioresorbable vascular scaffold (BVS), the drug-eluting stent restores blood flow by opening clogged vessels and supporting the healing process. Once treated with this BVS, blood vessels can move, flex and pulsate just like an untreated vessel. Following treatment, the stent is slowly metabolised by the body and completely dissolves over time.

In January 2011 Absorb received CE mark approval for use in Europe, with a full commercial launch planned for 2012. Absorb is the first bioabsorbable stent to be approved by a regulatory body. It can be used to repair vulnerable arteries before they close and cause complications; eliminates stent thrombosis and the need for long-term use of dual anti-platelet therapy; and does not interfere with diagnostic imaging techniques such as CT and MRI scans. Bioabsorbable stents can be used to treat multivessel disease, which requires the use of metallic stents that can interfere with future cardiac surgery. Another driving force behind this device is the fact that patients are expected to be more willing to use a bioabsorbable stent than a permanent metal stent.

On the flip side, many interventionalists doubt the feasibility of mass deployment of this stent and its performance in patients with highly calcified lesions is not yet established. To treat calcified lesions a stent must have a high radial force and a moderate outward expansive force, the lack of which could lead to intimal hyperplasia. For these reasons a metal stent is preferred. Efficacy, profile and deliverability are the current key clinical needs and any stent that can fulfil these properties is set to command a major share of the drug-eluting stent market.

2. Drug-eluting absorbable metal scaffold - BioTronik

Abbott's Absorb is a bioresorbable, everolimus-eluting, stent that is intended for use during interventional cardiac procedures to treat coronary artery diseases. Using a biodegradable polymer bioresorbable vascular scaffold (BVS), the drug-eluting stent restores blood flow by opening clogged vessels and supporting the healing process. Once treated with this BVS, blood vessels can move, flex and pulsate just like an untreated vessel. Following treatment, the stent is slowly metabolised by the body and completely dissolves over time.

In January 2011 Absorb received CE mark approval for use in Europe, with a full commercial launch planned for 2012. Absorb is the first bioabsorbable stent to be approved by a regulatory body. It can be used to repair vulnerable arteries before they close and cause complications; eliminates stent thrombosis and the need for long-term use of dual anti-platelet therapy; and does not interfere with diagnostic imaging techniques such as CT and MRI scans. Bioabsorbable stents can be used to treat multivessel disease, which requires the use of metallic stents that can interfere with future cardiac surgery. Another driving force behind this device is the fact that patients are expected to be more willing to use a bioabsorbable stent than a permanent metal stent.

On the flip side, many interventionalists doubt the feasibility of mass deployment of this stent and its performance in patients with highly calcified lesions is not yet established. To treat calcified lesions a stent must have a high radial force and a moderate outward expansive force, the lack of which could lead to intimal hyperplasia. For these reasons a metal stent is preferred. Efficacy, profile and deliverability are the current key clinical needs and any stent that can fulfil these properties is set to command a major share of the drug-eluting stent market.

3. Myolimus-eluting coronary stent - bioabsorbable polymer - Elixir Medical

A cobalt-chromium drug-eluting stent intended for the treatment of coronary artery atherosclerosis, the myolimus-eluting coronary stent is coated with an ultra-thin layer (<3µm) of bioabsorbable polymer that releases the drug and then biodegrades within three to six months.

The stent elutes a low dose (2.5µgm/mm) of myolimus, which is a macrocyclic lactone and mTOR inhibitor that prevents restenosis. In two separate clinical studies, a proprietary biodegradable polymer coating designed to biodegrade within three to six months, and another designed to biodegrade within six to nine months, were incorporated into the stent platform. Both coating platforms have the potential to maintain a low late lumen loss and low volume obstruction, and could result in a more biocompatible stent surface comparable with bare metal stents (BMS).

4. ZILVER PTX drug-eluting peripheral stent - Cook Medical

This self-expanding nitinol stent is intended to deliver a locally therapeutic dose of paclitaxel to patients with peripheral arterial disease (PAD) of the superficial femoral artery (SFA). It uses polymer-free technology and is a flexible, slotted tube that provides support while maintaining flexibility in the vessel upon deployment. It imparts an outward radial force upon the inner lumen of the vessel, establishing patency in the stented region. The stent is preloaded in a 7.0 French delivery catheter and can withstand the dynamic forces unique to the SFA thanks to its optimum flexibility.

Its main product features are a linear-cell stent design that ensures stable on-target deployment; meticulous electro-polishing that provides superior fracture resistance; and strength and flexibility to guarantee exceptional durability. ZILVER PTX received CE mark approval for treating PAD in August 2009 and is an investigational device in the US.

5. SeQuent Please - B. Braun

SeQuent Please is a drug-eluting balloon (DEB) catheter that is intended to deliver drugs directly to the lesion during angioplasty. It is based on PaccoCath technology that provides a unique matrix of paclitaxel and a hydrophilic spacer on the surface of the balloons. After the inflation, the matrix will dissolve immediately so that no material is left behind. SeQuent Please effectively treats stenosed coronary arteries without the need for permanent stent implantation.

DEBs have emerged as a promising alternative for treating restenosed arteries and are proven to be clinically effective in niche therapy areas such as bifurcation lesions, peripheral in-stent restenosis, and diffuse and small vessel disease. DEBs can overcome many of the safety concerns associated with drug-eluting stent placement, such as late-stage thrombosis. DEBs have high market potential in below-knee applications and diffuse disease. Around 10% of patients with coronary and peripheral arterial disease are not eligible for long-term anti-platelet therapy, for which DEBs can be used.

6. SAPIEN XT valve with NovaFlex delivery system - Edwards Lifesciences

Edwards' SAPIEN XT valve is a transcatheter, percutaneous aortic tissue heart valve intended for use in aortic valve replacement procedures to trafemorally treat severe calcific aortic stenosis. It is made up of bovine pericardial tissue and is transapically delivered using the low-profile NovaFlex delivery system. It has an expandable cobalt-chromium alloy balloon frame that allows for a significant reduction in its profile.

The device is being developed by Edwards Lifesciences Corporation. It is in the clinical stage of development and is expected to be approved by August 2016. The SAPIEN XT received the CE mark in 2010.

The global transcatheter heart valves market grew from $11.8 million in 2007 to $194.6 million in 2010 and is expected to grow at a compound annual growth rate (CAGR) of 19.9% to reach a market value of $691 million in 2017. The launch of transcatheter heart valves in the US would lead to further substantial growth in the market.

7. CoreValve ReValving system - Medtronic

The CoreValve ReValving system is a percutaneous aortic valve replacement system intended to replace a diseased native aortic heart valve without the need for open heart surgery. It is comprised of a porcine pericardial tissue valve mounted on a self-expanding frame and implanted via a low-profile (18F) delivery catheter and a disposable loading system. It uses components that are engineered to meet the requirements of a percutaneous implantation approach and is expected to be approved in 2013.

Anti-calcification technologies have been developed to enhance the durability of tissue heart valves and prevent the calcification of prosthetic valves, a major cause of tissue valve failure. Treatments with surface active compounds, such as alpha-amino oleic acid (AOA) and diphosphonates, reduce the calcium binding sites, delaying the calcification process. Medtronic's Mosaic porcine tissue heart valves are treated with AOA through a physiologic fixation process, which preserves their structure and function.

8. Abiocor II - Abiomed

AbioCor is a self-contained replacement heart. It is equipped with an internal motor to move blood through the lungs and around the rest of the body, simulating the rhythm of a heartbeat. It consists of an internal thoracic unit, rechargeable battery, miniaturised electronics package and an external battery pack. AbioCor II is a battery-powered, implantable replacement heart system that has been designed to operate without wires or any other material penetrating the patient's skin.

The implantable parts consist of the thoracic unit (replacement heart), the battery, the controller and the transcutaneous energy transmission (TET). The external parts comprise the console and the patient-carried electronics (PCE), such as the battery and bag, control module and external TET. The AbioCor II has no slated approval timeline as yet.

Globally, it is estimated that nearly 23 million patients suffer from heart failure. The global market for cardiac assist devices is forecast to grow from $728.2 million in 2009 to $1.3 billion by 2016. The focus is increasingly shifting towards developing miniature, implantable products for end-stage heart failure.

9. EXCOR ventricular assist device - Berlin Heart

EXCOR is an extracorporeal, pulsatile ventricular assist device mainly used as middle-term assistance for cases of severe heart attack and acute vascular inflammation. It bridges the waiting period until a heart transplant can take place and gives detailed information about biventricular, external assist devices. The inner surfaces of the blood chambers ensure optimum blood flow.

The titanium connectors ensure a precise connection between the pump and the cannulae, and its heparin coating prevents thrombogenesis. The pump has three membranes and can withstand any type of load.

The device is available with a mechanical tilting disc valve and a polyurethane velum valve. It is fitted with a de-airing stub and comes in various sizes for infants at a 10ml stroke volume to a blood pump at an 80ml stroke volume. EXCOR has FDA Humanitarian Device Exemption approval for use on children with heart failure.

10. LeadLess Pacemaker - Medtronic

The LeadLess Pacemaker is an implantable, leadless cardiac pacing device that delivers electrical impulses directly into the patient's right ventricle through a catheter to maintain a normal heart rhythm. It contains a miniature IC unit, a battery with a life of up to eight years, and uses the RF mechanism to transmit data to a monitoring unit. It can be monitored wirelessly.

The simple design and small size of the pacemaker enables it to be implanted by physicians without pacemaker implantation expertise, which is an advantage in emerging markets where there is a shortage of electrophysiologists or cardiologists; this allows a larger number of procedures to be done, thus benefiting a larger number of potential patients.

The global pacemakers and cardiac resynchronisation therapy-pacemakers (CRT-P) market is forecast to grow from $4.5 billion in 2010 to $5.3 billion by 2017 with a CAGR of 2.4%. Pacemaker and CRT-P device consumption rates in the US and Europe have decreased due to the effects of recession, as well as devices reaching their peak sales. Growing markets such as Brazil, China and India will play a key role in boosting revenues.