advanced medical technologies

(See September 2008 report #A125, “Ablation Technologies Worldwide Market, 2008-2017,” from MedMarket Diligence, LLC.  May be purchased online.)

Energy-based therapies generate sales of $13 billion in the United States alone, with probably another $12 billion in other developed markets worldwide. This represents around 13% of the total medical device market, and it is growing at 11% per annum—twice the growth rate for medical devices overall.

Several kinds of energy are used for medical purposes, including electrical energy, radiation, thermal and light (see chart, “Energy-Based Therapies by Modality”). When the market is analyzed by function, it emerges that the fastest-growing area within this dynamic sector is ablation therapies: a segment that includes devices using electrical, radiofrequency, thermal and other forms of energy.

A Market of $25 Bln and Growing

The total market for energy-based therapies is estimated at $25 billion, of which 60% is in the United States and the rest mainly concentrated in developed economies around the world.

Ablation therapies consist of several market segments. Arrhythmia ablation generates sales estimated at $60 million in the United States and $50 million internationally; ablation products for cancer therapy are valued at $225 million, of which $125 million are generated in the United States. Thus ablation therapies for these two leading indications—almost all consisting of RF devices and consumables—generated sales around $335 million in 2007. In fact, total RF ablation therapy sales are estimated at $1.5 billion worldwide. Also, this sector is growing much faster than the energy sector overall—annual rates are in the range 25%–30%.

Demographic Factors—Growth of the market for ablation therapies is based partly on dynamic changes in demographics. The baby boomer generation (i.e., the 78 million Americans born between 1946 and 1964) represents about one-third of the U.S. population and a similar proportion of the population of other developed countries. These maturing citizens have both the economic means and the demand for therapies that can extend their active lives and delay the visible signs of aging. Pushing the growth of energy therapies beyond basic changes in demographics are the unique benefits that they offer. They are typically less invasive and are generally employed without the need for an implant. The therapies can be precisely metered and can be repeated. Emerging energy modalities have the potential to grow at significant, double-digit rates over the next decade as delivery systems evolve.

Technological Change—The ablation market is also driven by technological innovation. First-generation ablation devices and catheters have been supplanted by more sophisticated newcomers. Some of the improvements are incremental, other represent more fundamental innovation. Typical is the recent introduction by VNUS Medical Technologies of the ClosureFAST catheter, an endovenous radio frequency (RF) ablation catheter that is designed to heat, shrink and close diseased saphenous veins (large leg veins) in three to five minutes.

VNUS claims treatment is as fast as laser ablation devices and causes minimal pain and bruising. The entire procedure, from insertion of the catheter to removal, can be completed in approximately 16 minutes—less than half the time required for previous RF-based procedures. The ClosureFAST catheter received FDA clearance in August 2006, and is now in general distribution.

A Handful of Companies Dominate

The energy-based medical device industry is led by a small group of companies: Medtronic, which has 30% share; St. Jude Medical, with 12%, and Varian Medical Systems, with 10%. A fourth strong presence was, until a few months ago, Boston Scientific, which had acquired Guidant, one of the pioneers in the field. However, Boston’s cardiac and vascular surgery business has been absorbed by the Swedish group Getinge (see MedMarkets, January 2008, “MedTech Companies Refine Therapies for Cardiac Ablation“) and is being marketed under the Maquet Cardiovascular name. Boston Scientific has retained its Blazer, Chilli, Steerocath and Maestro ablation systems for cardiac applications.

In terms of ablation therapies, different market contenders make their appearance. Valleylab, a division of Covidien, is a leader in the field of RF ablation for general surgery. In the arrhythmia ablation segment, the Johnson & Johnson company Biosense Webster has a significant share, competing with CryoCath Technologies, AtriCure, Getinge and St. Jude Medical.

Ablation Therapy in Cardiology

Ablation therapy using RF waves is used to cure or treat a variety of cardiac arrhythmias such as supraventricular tachycardia, Wolff-Parkinson-White syndrome, ventricular tachycardia and especially atrial fibrillation. The term laser ablation is a process by which the molecular bonds of a material are dissolved by a laser; the technique is used as a part of percutaneous transluminal coronary angioplasty (PTCA) to dissolve plaque and restore patency in stenosed coronary vessels. Rotoablation, also used in PTCA, consists of inserting a tiny, diamond-tipped, drill-like device into the affected artery to remove fatty deposits or plaque.

The major and fastest-growing use of ablation in cardiology is in the management of atrial fibrillation. Fibrillation is a disorder in which the orderly sequential propagation of an electrical impulse throughout the heart (which controls the heartbeat), is disrupted by multiple impulses so that the heart’s rhythm is disrupted. Atrial fibrillation involves ablating select areas of the heart’s upper chambers, which receive blood from the systemic and pulmonary circulations and pass it on to the ventricles.

Before the development of ablation therapy, treatment of atrial fibrillation consisted of drugs to control the heart rhythm, and surgery in selected cases. The object of surgery was to cut away tissues in the heart that were transmitting the errant electrical impulses. This was an open-heart procedure with all the attendant risks, and recovery usually took eight weeks or more.

Ablation therapy, like PTCA, is essentially noninvasive; a special ablation catheter is inserted into a peripheral vein and threaded up to the heart, where it is carefully positioned. RF pulses are then generated at the catheter tip to destroy tissue in the immediate vicinity. A series of such pulses is required to disrupt the abnormal electrical pathways.

Ablation Therapy in Cancer

A major and growing use of ablation is in the treatment of solid tumors, especially in the liver, lung, kidney and prostate.

RF ablation is a minimally invasive, FDA-approved treatment for cancer. Physicians worldwide have used RF ablation to treat thousands of patients for liver/kidney tumors, and bone cancer pain. RF ablation is an image-guided technique that kills cancer cells by heating and destroying them. It is an alternative when surgery is not likely to be successful or has failed, or when other medical conditions increase the risk of surgery.

In these cases, RF ablation can offer an effective treatment for small cancers; it is minimally invasive with no skin incision and there is minimal risk to the patient (who typically suffers little or no pain). The technique is cost-effective, with minimal hospital stay, and the procedure can be repeated if a new cancer appears.

Liver—RF ablation has achieved excellent results in treating primary liver tumors such as hepatoma or hepatocellular carcinoma. These tumors tend to grow slowly and are usually encapsulated. The technique is especially useful for patients who are not ideal surgical candidates, who cannot undergo surgery, who have recurrent tumors or who do not respond to conventional therapies.

Liver cancers most likely to be good candidates for RF ablation include tumors 4 cm diameter or smaller; cases with no more than three tumors per patient; and patients waiting for a liver transplantation who have a hepatoma.

The most common metastatic disease in the liver treated by RF ablation has been colon cancer. As with primary liver cancers, results are good if the tumors are small and few, and if there is no evidence of metastatic disease elsewhere, RF ablation can also be combined with surgery to treat patients who have several tumors in different locations.

Reports indicate that RF ablation results in complete cell death in the majority of hepatomas 3 cm–4 cm in size. Patients who have residual tumors can be re-treated if necessary. In patients who have metastatic colon cancer, re-treatment results are similar.

Lung Cancer—Lung cancers are among the most intractable of malignancies and the mortality rate remains high. Any incremental improvement in therapy is therefore to be welcomed. RF ablation may be an alternative nonsurgical treatment for selected patients who have cancers that are limited in size (less than 3 cm in diameter) and few in number (one or two). Tumors should be separate from vital structures in the body. RF ablation may also help lung cancer patients who are not candidates for traditional surgery due to advanced disease in the lungs, poor cardiac function and/or poor pulmonary function.

Kidney Cancer—Experience of RF ablation in kidney tumors is considerably less than with liver tumors. However, early results at the Mayo Clinic indicate that RF ablation is very effective for small tumors. In the Clinic’s experience with more than 70 patients, the tumor was destroyed in more than 95% of patients treated.

Surgery is the treatment of choice for most kidney tumors; however, RF ablation might be considered for patients who have only one kidney, or who have other medical conditions that might prevent surgery; also for elderly patients who might have difficulty with surgery or postsurgical recovery, and in cases where the tumor is less than 4 cm in size.

Diverse Factors Drive Market Growth

The ablation device market is a buoyant one supported by a number of significant growth drivers, and its annual growth is almost certain to be in the range of 15%–25% over the next few years. The industry landscape is changing with the introduction of new technologies and the development of new indications for ablation-based therapy. This market will be strongly influenced by a new graying population who knows what it wants in terms of health care and who are intensely cost-conscious.

Links

Accuray (Sunnyvale, CA; http://www.accuray.com)
AngioDynamics (Queensbury, NY; http://www.angiodynamics.com)
AtriCure (West Chester, OH; http://www.atricure.com)
AutoSuture (See Covidien)
Biosense Webster (Diamond Bar, CA; http://www.biosensewebster.com)
Boston Scientific (Natick, MA; http://www.bsci.com)
Covidien (Mansfield, MA; http://www.covidien.com)
CryoCath Technologies (Montreal, Quebec, Canada; http://www.cryocath.com)
DePuy Mitek (Westwood, MA; http://www.mitek.com)
Elekta (Stockholm, Sweden; http://www.elekta.com)
Endocare (Irvine, CA; http://endocare.com)
ERBE Elektromedizin (Tubingen, Germany; http://www.erbe-med.com)
Ethicon Endo-Surgery (Cincinatti, OH; http://ethiconendo.com)
Focus Surgery (Indianapolis, IN; http://www.focus-surgery.com)
Galil Medical (Yokneam, Israel; http://www.galilmedical.com)
Getinge (Getinge, Sweden; http://www.getinge.com)
Gynecare (Somerville, NJ; http://www.gynecare.com)
Gyrus Group (Reading, England; http://www.gyrusacmi.com)
HealthTronics (Austin, TX; http://www.healthtronics.com)
Hologic (Bedford, MA; http://www.hologic.com)
InSightec (Tirat Carmel, Israel; http://www.insightec.com)
Integra LifeSciences (Plainsboro, NJ; http://www.integra-ls.com)
Integra Radionics (Burlington, MA; http://www.radionics.com)
Irvine Biomedical (See St. Jude Medical)
Johnson & Johnson (New Brunswick, NJ; http://www.jnj.com)
Maquet Cardiovascular (Solna, Sweden; http://www.maquet.com)
Medtronic (Minneapolis, MN; http://www.medtronic.com)
Mentor (Santa Barbara, CA; http://www.mentorcorp.com)
Microsulis (Waltham, MA; http://www.microsulis.com)
MTS (Konstanz, Germany; http://www.mts-medical.com)
Olympus Surgical Orangeburg, NY; http://www.olympussurgical.com)
OmniSonics (Wilmington, MA; http://www.omnisonics.com)
Oncura (Plymouth Meeting, PA; http://www.oncura.com)
ProSurg (San Jose, CA; http://prosurg.com)
RITA Medical (See AngioDynamics)
Salient Surgical Technologies (Dover, NJ: http://www.tissuelink.com)
Sanarus Medical (Pleasanton, CA; http://www.sanarus.com)
SenoRx (Aliso Viejo, CA; http://www.senorx.com)
Siemens Medical Solutions (Malvern, PA; http://www.smed.com)
Smith & Nephew (London, U.K.; http://www.smith-nephew.com)
Somatex Medical Technologies (Teltow, Germany; http://www.somatex.com)
Spectranetics (Colorado Springs, CO; http://www.spectranetics.com)
Spectrasonics (Wayne, PA; http://www.spectrasonics.com)
St. Jude Medical (St. Paul, MN; http://www.sjm.com)
Theragenics (Buford, GA; http://www.theragenics.com)
TissueLink Medical (see Salient Surgical Technologies)
U.S. Surgical (See Covidien)
Urologix (Minneapolis, MN; http://www.urologix.com)
Valleylab (Boulder, CO; http://www.valleylab.com)
Varian Medical Systems (Palo Alto, CA; http://www.varian.com)
VNUS Medical Technologies (San Jose, CA; http://www.vnus.com)

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