Tag Archives: ablation

Growth of modalities in tissue ablation

An examination of the future markets for technologies used in therapeutic ablation has support for a general and sustained growth in ablation technology revenues:

Ablation-modality-growth-revenues

Source: Report #A145

However, when considering the relative growth of each of the modalities in tissue ablation, it is clear that some modalities are growing more aggressively than others:

Ablation-modality-growth-shares

Source: Report #A145

The “traditional” types of tissue ablation — electrosurgery and radiation therapy — are losing relative share as new modalities are able to penetrate caseload of other modalities, or even tap previously untreated patients and increase the aggregate caseload. In particular, radiofrequency and cryotherapy will demonstrate the highest growth over the 2011 to 2019 period.

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Tissue ablation is predominantly cancer therapy

Tissue ablation is defined as the “removal of a body part or the destruction of its function, as by surgery, disease, or a noxious substance.” Put more simply, ablation is considered to be a therapeutic destruction and sealing of tissue.

The technologies representing the majority of physical (rather than chemical) ablation are comprised of the following:

  • Electrical
  • Radiation
  • Light
  • Radiofrequency
  • Ultrasound
  • Cryotherapy
  • Thermal (other than cryotherapy)
  • Microwave
  • Hydromechanical

Source: Report #A145, "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities."

The largest share of the market for energy-based ablation devices is used in cancer therapy, primarily using the radiation therapy modality. Following that is general surgery with its use of electrocautery and electrosurgical devices, RF ablation, cryotherapy, etc. Cardiovascular is thought to be third, even though cardiovascular is making the most noise in the medical press with RF and cryoablation of atrial fibrillation, this segment is thought to be third in share order. The remaining applications are relatively small and fall in line behind the three leading sectors.

Growth in the Asia/Pacific Market for Ablation Technologies

 

The Asia-Pacific market for ablation technologies looks quite different from the Americas and European Union. Here, at present, the largest market is Japan, which accounts for the majority of the market, although by population and current growth rates, the People’s Republic of China has the greatest potential. Its greater than 1.3 billion population and, more importantly, the healthcare infrastructure that the government is putting into place ensure that China will continue to comprise an ever greater share of this market.

Asia-pacific-ablation

Data in the exhibit is drawn from MedMarket Diligence report #A145, "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities."

 

 

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Shifting caseload and markets in tissue ablation

Technologies to therapeutically ablate tissue (via destruction and/or removal of abnormal tissue or creation of a therapeutic lesion as in blocking errant electrical pathways in arrhythmia) represent a remarkably diverse set of tools despite their fundamentally common capability of tissue ablation.

Spanning electrical, radiation, light/laser, radiofrequency, ultrasound, cryotherapy, thermal therapy, microwave and hydromechanical and embodied in a wide range of medical devices and equipment, all ablation types simply destroy tissue.  The differences lie in respect to the specificity of each modality in targeting disease tissue and in respect to their capacity to be integrated in different types of instruments that may match the demands of specific clinical practices.

The recent history of ablation technology market developments reveals that, despite the specialization of modalities to specific tissues, or the efforts by manufacturers to carve out clinician or disease-state niches for specific modalities, growth in different ablation procedure types and clinical practice patterns has changed steadily but not always predictably.  Recent clinical results, new ablation device innovations and other developments have had the propensity to drive shifts in patient caseload between alternative ablation types.  Given the development and manufacturing costs, have largely and unsurprisingly maintained focus in typically one modality type, seeking to provide innovations in devices and equipment that accentuate benefits for there specific modality in specific clinical applications.

Below is illustrated the worldwide market for ablation technologies in 2009 and forecast 2019.

Source: "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities." Report #A145.

Ablation technology markets

Ablation technologies are used to destroy ("ablate") diseased or traumatized tissue for therapeutic benefit.  This includes destruction of cancerous tumors, ablation of endometrial tissue associated with endometriosis or abnormal uterine bleeding, creation of myocardial lesions to block the errant electrical signals in arrhythmia, and numerous others.

The largest share of the market for energy-based ablation devices is used in cancer therapy, primarily using the radiation therapy modality. Following that is general surgery with its use of electrocautery and electrosurgical devices, RF ablation, cryotherapy, etc. Cardiovascular applications are growing, particularly for cryoablation and radiofrequency ablation for arrhythmia, and now represent hold the third largest clinical area of ablation. The remaining applications are relatively small and fall in line behind the three leading sectors.

In the aggregate (i.e., for each modality worldwide), the largest segment is radiation-based ablation technologies, based to a large degree on the cost of the systems and their well-established use in clinical practice. 

Below is a chart of the 2011 markets for ablation technologies by modality, with their projected compound annual growth rates (CAGRs) from 2011 to 2019.

Source: "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities" (MedMarket Diligence Report #A145)

Evolution of ablation technologies and migration of caseload

Technologies to therapeutically ablate tissue (via destruction and/or removal of abnormal tissue or creation of a therapeutic lesion as in blocking errant electrical pathways in arrhythmia) represent a remarkably diverse set of tools despite their fundamentally common capability of tissue ablation.

Spanning electrical, radiation, light/laser, radiofrequency, ultrasound, cryotherapy, thermal therapy, microwave and hydromechanical and embodied in a wide range of medical devices and equipment, all ablation types simply destroy tissue.  The differences lie in respect to the specificity of each modality in targeting disease tissue and in respect to their capacity to be integrated in different types of instruments that may match the demands of specific clinical practices.

The recent history of ablation technology market developments reveals that, despite the specialization of modalities to specific tissues, or the efforts by manufacturers to carve out clinician or disease-state niches for specific modalities, growth in different ablation procedure types and clinical practice patterns has changed steadily but not always predictably.  Recent clinical results, new ablation device innovations and other developments have had the propensity to drive shifts in patient caseload between alternative ablation types.  Given the development and manufacturing costs, have largely and unsurprisingly maintained focus in typically one modality type, seeking to provide innovations in devices and equipment that accentuate benefits for there specific modality in specific clinical applications.

Below is illustrated the worldwide market for ablation technologies in 2009 and forecast 2019.

Source: "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities." Report #A145.

Cryo Ablation Products

Cryotherapy, also called cryosurgery, cryoablation or targeted cryoablation therapy, is a minimally invasive treatment that uses extreme cold to freeze and destroy diseased tissue, including cancer cells. Although cryotherapy and cryoablation can be used interchangeably, the term “cryosurgery” is reserved best for cryotherapy performed using an open, surgical approach. During cryotherapy, liquid nitrogen or argon gas is applied to diseased cells located outside or inside the body. Physicians use image-guidance techniques such as ultrasound, computed tomography (CT) or magnetic resonance (MR) when using cryotherapy inside the body.

Below is a table of selected cryo-based products for ablation.

Cryotherapy Ablation Device Companies, Products, Applications* & Market Status*

[table “22” not found /]

*Note:  For detail on each product’s primary application, U.S. market status and international market status, see Report #A145.

Source: MedMarket Diligence, LLC; Report #A145, “Worldwide Ablation Technologies Market 2010″.

Barrett’s esophagus and ablation treatment

Barrett’s esophagus (BE) is a metaplastic alteration of the normal esophageal epithelium that is detected on endoscopic examination and pathologically confirmed by the presence of intestinal metaplasia on biopsy. It affects mostly Caucasian males over the age of 50. The cellular change in the lining of the esophagus is thought to be caused by chronic injury due to gastroesophageal reflux disease (GERD). Its major significance is that it is a predisposing factor for esophageal adenocarcinoma. The cellular changes place the patient at a significantly increased risk for developing esophageal cancer, between 200 and 6,660 times that of the general population depending on the severity of the Barrett's diagnosis. Cancer of the esophagus carries a high mortality rate, is the seventh leading cause of cancer death in the U.S. and has displayed a rapid rise in annual incidence. In US, an estimated 3.3 million people have BE, although only 1 in 200 will develop cancer.

(inset source: Wikimedia Commons; (Endoscopic image of Barrett's esophagus with permission to place in public domain taken from patient — Samir धर्म 05:21, 17 May 2006 (UTC))

 

Current and Emerging Treatment Trends
Standard treatment for BE consists of treating the GERD and watching to see if the BE develops into esophageal cancer. However, according to a new study from the Mayo Clinic, BE can often be eliminated using endoscopic radiofrequency ablation (RFA), and most patients remain free of BE five years following the initial procedure.

In this prospective, multi-center trial conducted from May 2004 to November 2009, researchers performed endoscopic RFA, designed to burn away the abnormal Barrett's cells, in patients with intestinal metaplasia. For 50 RFA patients in whom BE had been eliminated at the two and a half year assessment, endoscopy was performed at five years. Results showed that 46 of the 50 remained free of BE, and four patients had low levels of residual disease that was eliminated in a single follow-up RFA session.

Applicable Ablation Technologies: Rationale for Use and Effect on Tissues
There are RF ablation devices currently on the market (Barrx Medical) which are intended for the treatment of Barrett’s esophagus. The HALO360 and the HALO90 Ablation Catheter use radiofrequency energy to ablate the irregular Barrett’s cells. The ablated tissue sloughs away, leaving behind a clean lesion.

Another product, currently in development, utilizes cryotherapy to achieve the same goal. According to C2 Therapeutics’ patent application, the company is developing a medical device for treating esophageal tissue which consists of a catheter, a balloon, which may be placed within the esophagus of the patient, and a refrigerant. The refrigerant is delivered into the interior of the balloon so as to place the balloon into an expanded, cooled state. The balloon can then press against and cool the esophageal tissue. The company is currently operating in stealth mode.

Source: MedMarket Diligence, LLC; Report #A145, "Ablation Technologies Worldwide".

Liver cancer and ablation

Below is an excerpt from MedMarket Diligence reportt #A145, "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities", Report #A145.

Hepatocellular carcinoma (HCC) is the ninth leading cause of cancer death in the USA, the third leading cause worldwide, and the fifth most common solid tumor cancer. It begins in the cells of the liver and is usually not detected at an early stage, often resulting in a poor patient prognosis. The incidence of primary liver cancer in the USA is approximately 20,000 cases per year and is rapidly growing worldwide. In a report published in the May 7, 2010 issue of Morbidity and Mortality Weekly Report (MMWR), the average annual incidence rate of hepatocellular carcinoma in the U.S. increased significantly, from 2.7 per 100,000 people in 2001 to 3.2 per 100,000 people in 2006, with an average annual percentage change in incidence rate of 3.5%.

Globally there are approximately 660,000 cases per year. More than 80% of these cases occur in developing countries, with China alone accounting for over 55% of the total. Rates are more than twice as high in men as in women. Liver cancer rates are the highest in West and Central Africa and in Asia. In contrast, incidence rates are lowest in developed countries, with the exception of Japan. Among primary liver cancers occurring worldwide, hepatocellular carcinoma represents the major histologic type and likely accounts for 70-85% of cases.

Unfortunately, most cases could have been prevented. Chronic hepatitis B and C virus infections, which are highly prevalent in developing countries, account for 78% of all hepatocellular cancer in the USA. Prevention of virus transmission and progression of chronic viral disease has been shown to decrease the incidence of this cancer.

Current and Emerging Treatment Trends in Treatment of Liver Cancer

Liver cancer is one of the most fatal cancers, with five-year relative survival rates less than 11% even in developed countries. There are few non-surgical therapeutic treatment options available. Treatment may include surgery, chemotherapy, radiation therapy, or percutaneous ethanol injection, but radiation and chemotherapy are largely ineffective in the treatment of primary liver cancer. The standard first line treatment for liver cancer is surgery, either resection or liver transplantation, but surgery is confined to those patients whose tumors are confined to the liver, are no larger than 5 cm, and where the cancer has not invaded the adjacent blood vessels, organs or lymph nodes. Approximately 70% to 80% of patients are ineligible for surgery.

Ablation Technologies in Liver Cancer

Radio frequency ablation (RFA), with limitations, has shown to be effective and has increasingly become the standard of care for non-resectable liver disease. Radiofrequency ablation devices work by sending alternating current through the tissue. This creates increased intracellular temperatures and localized interstitial heat. When temperatures exceed 60°C, cell proteins rapidly denature and coagulate, killing the cells and producing a lesion. The lesion can be used to resect and remove the tissue or to simply destroy the tissue, leaving the ablated tissue in place.

(See inset, from "Radiofrequency Ablation for Cancer", Mayo Clinic.) 

Laser-induced interstitial thermotherapy (LITT) and microwave have also been utilized for the ablation of HCC tumors, although these two treatments do not seem to work as well on large tumors as other treatments. Interstitial laser photocoagulation uses a thin optical fiber (which is inserted into the center of the tumor) and a laser. When the laser light is emitted, the cancerous cells undergo thermal necrosis. Interstitial microwave kills the tumor cells by heating them to a high temperature (50 degrees C) for an extended period of time.

Minimally invasive irreversible electroporation is another treatment for HCC tumors. Electroporation increases the permeability of the cell membrane by exposing the cell to electric pulses. Irreversible electroporation opens the cell membrane in such a way that the cell cannot reverse the process and close the membrane. This open membrane causes the cell’s death. Irreversible electroporation is felt by some researchers to be comparable to cryosurgery, nonselective chemical ablation and high temperature thermal ablation.


Products, technologies, clinical applications and market for ablation technologies are detailed in MedMarket Diligence reportt #A145, "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities".

Ablation, other energy-based tissue treatment markets, procedures

(Report updated. See 2010 report on Ablation Technologies Worldwide.)

The global market for medical devices is $200 billion opportunity and at least 13% of this market involves products that provide the controlled application of energy to tissue. The segment is dominated by high technology products ranging from devices that can heat and cool tissue over a 600° C temperature range of -200° C to +400° C to those that can vibrate at fifty five thousand cycles per second to denature tissue. While a significant share of the energy-based therapies market is for elective procedures such as refractive eye surgery and cosmetic hair removal, treatments for chronic diseases make up the vast majority of the applications of these technologies.

Underlying the growth of this market will be changes in demographics. The baby boomer generation–those born between 1946 and 1964–represents about one-third of the population in economically-developed countries. Many of these ageing 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 than traditional surgery 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.
 

Ablation Technologies Markets and Representative Procedures by Modality

ablation-segments-procedures

Source:  Drawn from Report #A125, "Ablation Technologies Worldwide Market, 2008-2017."