Category Archives: cryosurgery

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)

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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.

Differential growth rates in global ablation technologies markets

With growth rates between 3% and 18% annually in the global market, there is a wide range of growth in the market for ablation technologies. Relative rates of growth arise from a variety of drivers for the different ablation types, including existing or installed base of systems, extent of clinical testing on emerging modalities, the demand-to-cost ratio for new systems, the capital equipment cost and the breadth of different ablation procedures that can be performed by any given modality.  This results in relatively low rates of market growth for electrosurgical and thermal systems and relatively high rates for cryotherapy and radiofrequency ablation.

Source: "Ablation Technologies Worldwide Market, 2009-2019: Products, Technologies, Markets, Companies and Opportunities", published by MedMarket Diligence, LLC.

The rates of growth implicit in the above forecast are for the worldwide ablation market by modality.  On a geographic basis, the growth rates show more pronounced differences among the ablation types, and in some cases, as in China, where growth is also markedly higher across the board, the impact of lower initial installed bases for some traditional ablation types (e.g., radiation) as well as newer types (e.g., ultrasound) result in reordered rankings of the modalities by growth rate.  For comparison, below is the percent of the total market, by ablation modality, for China and Spain by 2019.

Source: Report #A145.

Radiofrequency ablation systems driving a multi-billion dollar market

One of the most active areas of development (products and market) in the field of ablation technology is in radiofrequency ablation systems.  Currently at over $1.5 billion in sales globally, radiofrequency ablation sales will exceed $7 billion by 2019 (see Report #A145).

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, resulting in 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.

Due to adverse effects such as charring, as well as perceived limitations on the use of RF devices, improvements have been developed and marketed which are designed to better control and direct the high temperatures produced at the tip of the RF device. These include so-called temperature controlled and fluid (saline or water) cooled versions.

Temperature Controlled. One way to control the temperature at the tip of the RF electrode is to build in a feedback mechanism between the tip of the device and the RF generator. For example, in a device such as Covidien’s Cool-tip system, the RF generator was designed with a feedback algorithm. This algorithm senses tissue impedance and automatically delivers the best amount of radiofrequency energy for the situation. The Cool-tip’s electrode design serves further to eliminate tissue charring while allowing delivery of the maximum amount of energy, resulting in the ability to ablate a larger zone of tissue more quickly.

Fluid Cooled. In the highly-popular fluid-cooled devices, the electrode’s internal circulation of water cools the tissue adjacent to the exposed electrode, maintaining low impedance during the treatment cycle. Low impedance permits maximum energy deposition for a larger ablation volume. It also decreases the risk of charring, and allows the surgeon to work faster.

Catheter Manipulation Systems. Another recent development is the use of routine RF electrophysiology catheters in conjunction with a robotic catheter manipulation system, for both diagnostic and ablative EP applications. Examples of such systems include Catheter Robotics’ Remote Catheter Manipulation System, Hansen Medical’s Artisan Control Catheter/Sensei Robotic Catheter System, and Stereotaxis’ Magnetic Navigation System.

Benefits of such systems include use of a catheter which is already familiar to the EP; the ability to manipulate the catheter (once it has been inserted into the heart) via a system from outside of the zone of radiation, and thus eliminate the need to wear the lead aprons; and the EP can then guide the procedure while watching the EP monitors and x-ray images.

Companies active in the marketing and/or development of radiofrequency ablation products include:

Advanced Cardiac Therapeutics, AngioDynamics, Ardian, Arthrex, ArthroCare, Asthmatx, Atricure, Bard EP, BÂRRX Medical, Inc., Baylis Medical (Kimberly-Clark), Biosense Webster (JNJ), Biotronik, Boston Scientific, Bovie Medical, BSD Medical, BTL Industries, Inc., Cardima Inc., Celon AG, ConMed, Cook Medical, CoRepair, Covidien, Endosense, EndyMed Ltd., EP Limited, Erbe Elektromedizin GmbH, Estech, Halt Medical, Hansen Medical, Gyrus ACMI (Olympus), Hologic, Integra Radionics, Mederi Therapeutics, Inc., Medtronic, nContact Surgical, Inc., OrthoDynamix LLC, PEAK Surgical, Salient Surgical Technologies, Smith & Nephew, St. Jude Medical, Stereotaxis, Stryker Interventional Spine, Valleylab (Covidien), VNUS Medical Technologies (Covidien), and Voyage Medical.


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

Ablation technologies energized for growth

"Ablation" may be generally described as a therapeutic destruction and/or sealing of tissue, whether to destroy diseased tissue, remove necrotic tissue, create a lesion to produce a therapeutic effect (as in treatment of atrial fibrillation) or to otherwise dissect tissue for therapeutic benefit.

[See "Ablation Technologies Worldwide Market 2009-2019". Report #A145]

As a fundamental tissue effect, ablation can in principle be accomplished by a large range of alternative modalities or energy types, but the practical application of ablation to different clinical practices has emerged from the constraints that specific target tissue types put forth — minimizing collateral tissue damage, creating ideal lesion types, limitations of the surgical approach that lend greater or lesser advantage to one modality compared to others, etc.

The technologies representing the range of alternative ablation types are grouped into nine sectors:

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

In 2010, given its long history in medicine, radiation represented the largest share of global revenues of energy-based ablation devices, followed by light (essentially laser) with 19% and ultrasound with 15%. The total market is forecast to grow at a compound annual growth rate (2010-2019) of 11.2%. 

Despite the economic slowdown of 2008-2009, the energy-based ablation devices market continued growing vigorously and is expected to continue to grow at a strong rate over the next five+ years. The total CAGR of 11.2% is deceptively modest, because these figures reflect the combined market sizes and growth rates of nine sectors. Those nine sectors, or modalities, vary widely in size and growth rates: from thermal, with an estimated CAGR of under 3%, to cryotherapy with a CAGR approaching 19.5%. Four of the modalities are forecast to experience compound annual growth rates equal to or exceeding 11%.

Electrical and electrocautery devices have long been a mainstay of the surgeon’s toolbox, and they will continue to be used for the foreseeable future. Some estimates say that as much as 80% of all surgical procedures make use of one of these devices. Key among the advantages offered by these products is the ability, depending upon the procedure, to assist the surgeon to conduct a procedure rapidly—often more quickly than with a cold scalpel. Electrical ablation is used in a wide array of surgical procedures, including colon resection, hysterectomy and gastric bypass, to name a few.
Radiation devices cause destruction of target tissues by disruption of cellular mechanisms, often with surgical precision, without ever cutting the skin. These systems have advanced to a high-tech level unforeseen even ten years ago.

Radiation ablating equipment includes traditional radiotherapy machines, image-guided radiotherapy (IGRT) and intensity-modulated radiotherapy (IMRT). Over the last ten years or so, radiologists have been moving towards more advanced treatment techniques, such as those utilizing multiple or non-coplanar beams, 3-dimensional conformal radiotherapy (3DRT) and IMRT, to treat tumors. Physicians view the accuracy of computed tomography-based 3-dimensional target delineation, which provides more detailed targeting than does 2-dimensional design, as another very attractive treatment option.

Light-based or laser devices use high-intensity light to shrink or destroy tumors. Various lasers have different effects on different tissues, depending on the laser’s wavelength. Lasers commonly used for medical and/or aesthetic purposes include Erbium:YAG, ruby, CO2, and neodymium:YAG-laser (Nd:YAG). Also in this category are femtosecond and excimer lasers. Femtosecond lasers allow extreme precision in surgery. The possibilities for its use now include but are not limited to femtosecond keratoplasty, astigmatic keratoplasty, and keratoconus. Excimer lasers typically produce ultraviolet light, and are used in LASIK eye surgery.

Radiofrequency energy is characterized by a specific frequency measurable in Hz. Medical devices that emit RF energy produce a change in the electrical charges of the treated tissue, creating an electron movement. Electrosurgical cutting uses sharply focused, intense heat at the surgical site to cut the tissue. By holding the electrode a small distance away from the tissue, the surgeon can produce the most intense heat over a very short amount of time. This results in vaporization of the tissue and the desired cutting effect. Vessel sealing and ligating devices usually utilize electrical energy combined with pressure to seal vessels and to cut off small bits of tissue.

Ultrasound energy relies on the fact that as an acoustic wave propagates through tissue, part of it is absorbed and converted to heat. Focusing sound waves allows concentrated energy deposition to occur deep in tissue, allowing precisely localized heating and thermal coagulation while sparing intervening tissue. High intensity focused ultrasound, or HIFU, treats a precisely defined portion of the targeted tissue. Because this technology can achieve precise ablation of diseased tissue, it is often referred to as ‘HIFU surgery’, or ‘non-invasive HIFU surgery.’

Cryotherapy uses extreme cold to freeze and destroy the target tissue, such as a cancerous tumor. It is applied in a freeze-thaw process. The cryotherapy probes, needles or catheters are carefully positioned in place using ultrasound guidance, then the freezing agent, argon gas, is allowed to circulate through the cryotherapy probes, causing an ice ball to form in the tissue at the tip of the probes. The tissue is frozen rapidly, then thawed slowly and completely, and then is put through a second freeze-thaw cycle. It is the intensity of the freezing that determines the ultimate response of the targeted tissue, which may range from chilled to inflammation to cell death. Different cell types show different sensitivities to freezing, a fact which can be used for therapeutic purposes. For example, prostate cancer cells demonstrate different susceptibilities to freezing than do other tissues, a difference that has been linked to the presence of the androgen receptor.

Thermal ablation devices may be engineered to produce a variety of temperatures in tissues, depending upon the intended usage. These temperatures may range from 39 – 40 °C up to as high as 80 – 90 °C, under well-controlled conditions. When hyperthermia is used, there is evidence of a number of processes taking place, which can include enhancement of the anti-tumor effects of radiation and of various drugs; induction of immunological processes; induction of gene expression and protein synthesis; and general changes to the tumor’s environment which make the tumor more accessible to some therapies. Above 43°C, the heat itself has a cytotoxic effect on the cells.

Microwave hyperthermia is a non-ionizing form of radiation therapy. Low levels of microwave energy are used to vigorously vibrate water molecules in tissue to quickly and effectively heat the tissue to a physical penetration depth defined by the microwave frequency. Microwave has also been shown to improve the results of radiation therapy for the treatment of some recurrent and progressive tumors. The resulting hyperthermia destroys cancer cells by raising the tumor temperature to a ‘high fever’ range. Recent research appears to show that cancer cells may be particularly vulnerable to microwave-induced hyperthermia due to their high acidity. Microwave energy disrupts the stability of the cellular proteins and kills the cells.

Hydromechanical ablation is energy-based tissue destruction accomplished via mechanical means, such as extracorporeal shock wave lithotripsy devices, or jets of water or saline. In extracorporeal shock wave lithotripsy, the lithotriptor uses an external hydromechanical energy source to break up the stone with minimal collateral damage. The successive shock wave pressure pulses result in direct shearing forces which fragment the stones. Water jet surgery, a form of dissection which has been used successfully for several years, employs the kinetic energy of the water jet to separate different tissue types by their varying elasticity and firmness. In hepatic surgery, for example, the device can selectively differentiate between liver parenchyma, blood vessels and bile ducts. This modality does not cause thermal damage to tissue and can sculpt, ablate and cauterize bleeders.


The above is excerpted from Report #A145, published 2010 by MedMarket Diligence, LLC.

A $10 billion global medtech market for ablation technologies

The world market for energy-based ablation devices includes electrical, radiation, light, radiofrequency, ultrasound, cryotherapy, thermal, microwave and hydromechanical. 

The total market in 2009 was valued at nearly $10 billion. For the market period 2010-2019, the compound annual growth rate (CAGR) for the global market is projected to be 11.2%. The CAGR is deceptively modest, because these figures reflect the combined market sizes and growth rates of nine sectors. Those nine sectors, or modalities, vary widely in growth rates: from thermal, with an estimated CAGR (’09-’19) of under 3%, to cryotherapy with a CAGR of 19.5%. The energy-based ablation devices market is growing vigorously and will continue to grow at a strong rate during the study period.

(As defined in the MedMarket Diligence report #A145), the Americas consist of the USA, Canada, Mexico and Brazil; the European Union (EU) includes the United Kingdom, Germany, France, Spain, Italy and BeNeLux; Asia-Pacific represents Japan, China, India and Australia.

The different energy-based ablation segments vary widely in size, as shown in the following exhibit. Radiation accounted for one-third of the entire market in 2009, followed by light-based ablation (e.g., laser) with 19%. These two modalities accounted for 52% of the dollar value of the energy-based ablation device market in 2009. The CAGR (’10-’19) for radiation is about 8.1%; that of light is about 11%. 

Global Ablation Market Segments

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