Approved neurosurgery indications for high-strength surgical glues in Europe

High-strength glue products were approved for topical closure applications in the United States in the late 1990s. Outside the United States, high-strength glues and adhesives have been approved in some countries for a number of years and have built up a track record of use in internal surgery. With time, high-strength glues will come to be used in a wider range of procedures and enable new procedures to be performed more economically with better outcomes and reduced morbidity and mortality.

We have reviewed applications and indications of commercial products and include below a list of approved and indicated neurosurgery procedures in the European Union, as it illustrates the growing potential for these high-strength glues once they gain universal approval and adoption within the surgical community worldwide. These products have high-strength sealant and adhesive properties that will lead to their increasing adoption by clinical practitioners, starting with surgical closure and specific internal procedures for which there is no alternative. We expect that this will be followed, in the next five years, by increasing usage for gluing of tissues in vascular, neurological, spinal, orthopedic, and other procedures. We also envisage the introduction of new products and technologies that are under development to address the failings of existing first-generation high-strength glue products, to make them less toxic, more resorbable, and with higher strength.

  • As a sealant in cranial and spinal dural plastic surgery to prevent CSF fistulas.
  • As a sealant in dural plastic surgery in residual cavities following tumor removal.
  • As sealant in dural lacerations in hemilaminectomy operations.
  • Closure and filling of cranial fossae and cavities.
  • Closure of the sella turcica by the sphenoidal route.
  • Gluing of bone and osteocartilaginous fragments.

(See the complete list of procedures in Europe for high strength glues, encompassing the specific procedures in cardiac surgery, digestive tract endoscopy, general surgery, gynecological surgery, urological surgery, interventional radiology and vascular neuroradiology, pediatric surgery, and ENT surgery in Report #S175.)


From "Worldwide Surgical Sealants, Glues, Wound Closure and Anti-Adhesion Market, 2009-2013". Report #S175.

New Surgical Techniques Drive Market Opportunity for Advanced Surgical Closure and Securement

In cardiovascular and spine surgery, multi-billion dollar markets were created from entirely new procedures between 1980 and 2000, with subsequent segmentation in later years particularly as new minimally invasive procedures were developed towards the end of the 20th century. In the cardiovascular arena, the development of new procedures for angioplasty and bypasses in the late 1980s led to these procedures being performed in increasing numbers. This increase was driven by lowered risk associated with the new procedures, new product availability, and surgeon capability coupled with substantial changes in demographics caused by aging, lifestyle and economics. For example, it is estimated that approximately 20% of the over 80-year-old population suffers from some form of coronary heart disease in the United States, and the development of angioplasty procedures created a new preferable (to open heart surgery) treatment for this population.

Whereas in the United States there were 50,000 open heart surgery treatments in 1980, towards the end of the twentieth century there were 150,000 open heart bypass operations per year. There are approximately 375,000 cardiac vascular reconstruction procedures per year. In cost terms, each angioplasty in the United States costs approximately $8,000 and bypass operations cost approximately $25,000. Surgical closure and securement products are routinely used in these procedures, and new techniques like this cardiovascular example, with associated new technologies, are likely to arise in the next decade to create new market opportunities. 

During this same time frame, spine surgery has also seen tremendous growth, spurred by the combined catalyst of new technology development and an increasingly active and growing senior population.  Until the 1980s spinal surgery focused on multi-level segmental fusion procedures to fuse together several vertebrae to decrease the chance of failure at the bone metal interface. Fixation methods using Harrington hook and rod systems, Luque rods, and wires were used to achieve fusion. These procedures are notable by their invasive nature; they are associated with significant trauma and require substantial rehabilitation care for successful outcome. They were therefore initially used only in extreme cases of congenital deformity and cases of extreme trauma and pain.  In the mid- to late 1980s, a number of manufacturers developed bone screws for use in combination with these hooks and rods, which improved the achievement of stability without requiring multi-level fusion, and the emergence of threaded fusion cages in the mid-1990s added to the surgeon’s treatment options, with resultant increase in fusion success rates. The market for these products grew from tens of millions in 1980 to a $2.4 billion world-wide market in 2000. Use of adjunctive products for surgical closure and securement have already gained foothold in these procedures, which continue to grow.

Less invasive approaches to spine surgery and concomitant technology development have expanded the patient population for spine fusion procedures.   Simultaneously, a persistent demand has existed among a high caseload of patients with spine trauma and disease seeking solutions that diminish or eliminate pain, and yield lasting high quality outcomes including spine flexibility, strength and the opportunity for a more active lifestyle.  These include systems for dynamic stabilization, interspinous process spacers, artificial discs and other products.  The performance of procedures involving these products, while improving broadening the applicable caseload and improving the clinical outcomes of patients, will no less demand the use of advanced surgical closure and securement products to facilitate procedures, reduce complications and optimize results.  Fibrin sealants and glues, high strength glues and hemostasis products have established their current and future places in these fields.

Cardiovascular and spine surgery are two among many surgical fields continuing to grow, driven by patient demand and facilitated by technologies that improve outcomes.  Bariatrics, gynecologics, orthopedics, gastrointestinal and other surgeries are witnessing similar increases in procedure volume.   


See the MedMarket Diligence report #S175, "Worldwide Surgical Sealants, Glues and Wound Closure, 2009-2013."

How to avoid recession, a medtech option

Healthcare is viewed conventionally as being inelastic to economic downturns, since healthcare needs are independent of economic variables.  But with the extent of the current recession reaching into credit availability, those medtech companies with short term financing needs – seed stage or startups, early stage, and developmental stage – have clearly depressed economic immunity.  But those entities with established product lines, operating revenues, and deep pockets are finding the economy to be largely irrelevant. 

Abbott Vascular, case in point, demonstrated this in 2Q 2009 with: 

  • A 10.5% increase in worldwide operational sales
  • Worldwide Humira (arthritis drug) sales up 32.8%
  • Worldwide vascular operational sales up 43.0%, driven by its Xience drug-eluting stent contributing to coronary stent sales increase of 83.5% 

To be clear, all medical technology companies have been affected by the recession, but companies like Abbott Vascular have more armor in the form of operating revenue, debt capacity, and, most importantly, innovation that shields them from the recession’s blows. 

The coronary stent market, in particular, has proven an area of steady growth for market participants like Abbott Vascular, Boston Scientific and (though declining in shares) J&J/Cordis. Significant size and growth prospects exist for the major segments of this market (The global coronary stent market is the subject of MedMarket Diligence’s Report #C245.)

Ablation technologies proliferate from their many clinical benefits

Surgical management of soft tissues via "ablation" therapies, in which alternative energy types (radiation, electrosurgcal, ultrasound, etc.) are applied to excise, destroy, or otherwise produce a therapeutic effect at the tissue level has undergone a proliferation in development with all of these alternatives vying for caseload in clinical applications as diverse as tumor ablation, arrhythmia ablation, endometrial ablation for treatment of endometriosis, ophthalmic procedures for vision and disease treatment, cosmetic, and many others.

The alternatives run the gamut from well established, high volume, low growth procedures like conventional x-ray to emerging, relatively low volume, high growth procedures like microwave ablation in cancer and arrhythmia ablation, and every other type of procedure in between.

Below illustrates the growth versus market size distribution of ablation technology alternatives.

ablation-bubbles

Source:  MedMarket Diligence, LLC; Report #A125, "Ablation Technologies Worldwide:  Products, Technologies, Markets, Companies and Opportunities."

 

Select technologies in ablation are among the most dynamic growth markets in the entire medtech sector.  The therapeutic and other benefits with these technologies included that 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 therefore have the potential to grow at significant, double-digit rates over the next decade as delivery systems evolve.

Coronary artery disease treatment: A gamut of options

Treatment of coronary artery disease has become a sort of living laboratory for the evaluation of an incredible range of alternatives.  Put simply, the options for patients fall generally to either a coronary artery bypass graft procedure to simply reroute new graft plumbing around the old, clogged pipes, or revascularizing the clogged arteries via a catheter-based procedure.  However, the variation even across just these two choices is extraordinary now and will continue to be more complex.

The choices include multiple options for both coronary artery bypass and percutaneous coronary intervention, and others:

1)      Coronary artery bypass grafting
a)      Open surgery
b)      Closed, minimally invasive surgery (MIDCAB)
c)      Off-pump (“beating heart”) bypass (OPCAB)
d)     Robotically assisted bypass (RACAB)
e)      Totally endoscopic coronary artery bypass (TECAB)
2)      Percutaneous revascurization
a)      Angioplasty alone
b)      Angioplasty with stenting
i)        Drug-eluting stents
ii)      Bare metal stents
iii)    Bioabsorbable stents
iii)    Other stent coatings
c)      Atherectomy
d)     Transmyocardial laser revascularization
e)      Drug-eluting balloons
3)      Gene therapies
4)      Cell therapies
5)      HDL therapy
 

The forces that have driven development of the above options include the drives to reduce the invasiveness of treatment, improve the long term outcome of procedures (including minimizing or eliminating the need for repeat procedures) and, if possible, reduce overall cost.

Currently, the use of drug-eluting stents is garnering a considerable share of caseload as a result of its ability to minimize invasiveness (cath lab procedure, sometimes outpatient), improve outcomes (reducing restenosis and need for repeat procedures) and lowering cost (at least by comparison to open surgical bypass).  However, the medtech arena never remains completely static, so shares of caseload will continue to shift as new technologies and therapeutic options (e.g., bioresorbable stents) continue to be developed and tested.


This post synopsizes content from "Worldwide Drug-Eluting, Bare Metal and Other Coronary Stents, 2008-2017", published May 2009 by MedMarket Diligence, LLC.

 

 

Coverage of ongoing developments in interventional cardiology and surgical technologies

Through the course of tracking multiple subjects for ongoing awareness of new developments in clinical practice, product development, market development and other activity impacting the medtech markets we track, we have identified multiple worthwhile sources of content, which in turn has provided background to our in house research and analysis, which we publish through our proprietary Market and Technology Reports and the Medtech Startups Database, as well as through this blog.

For the purpose of providing regularly available information of interest to our core audience, we will be progressively building aggregates of our proprietary content and select outside sources through specific pages on the MedMarket Diligence website.  Initially, there are two specific topics we will be tracking and the regularly updated content on them are provided at the links below:

We will be expanding these topics as time permits.  We suggest you bookmark them for future reference.  

We welcome any feedback on other topics of interest, as well as any relevant newsfeed sources (many or all of which can be integrated).

 

 

Ablation and other energy-based technologies with multiple clinical applications

Manufacturers of ablation and other energy-base therapeutics are both witnessing and driving a steady evolution of multiple technologies with potential to produce therapeutic (or, in some cases, simply cosmetic) tissue effects, with different energy types competing head-on for caseload.  These innovators have continued to improve their understanding of the nature of each energy type’s impact on the target tissue(s) and have optimized the delivery to improve outcome, improve ease of use and minimize adverse collateral tissue effects or other complications.

To illustrate the breadth of applications for energy-based technologies, see the excerpt below from the table of contents to the MedMarket Diligence report #A125, "Ablation Technologies Worldwide Market, 2008-2017: Products, Technologies, Markets, Companies and Opportunities." 

 

SECTION 1:  ENERGY-BASED THERAPIES BY DISEASE STATE AND TECHNOLOGY
1.1  Cancer
1.1.1  Brachytherapy
1.1.2  Cryotherapy
1.1.3  Microwave Ablation
1.1.4  Radiation Therapy
1.1.5  Radiofrequency Ablation
1.1.6  Stereotactic Surgery
1.1.7  Laser Ablation
1.1.8  Photodynamic Therapy
1.1.9  Ultrasonic Ablation
1.2  Cardiovascular Disease
1.2.1  Angina Pectoris
1.2.2  Atrial arrhythmias
1.2.2.1  Cryoablation
1.2.2.2  Electrical Cardioversion
1.2.2.3  Microwave Ablation
1.2.2.4  RF Ablation
1.2.2.5  Temperature Controlled
1.2.2.6  Fluid Cooled
1.2.3  Bradycardia
1.2.4  Critical Ischemia
1.2.5  Vascular Occlusive Disease
1.2.6  Ventricular Arrhythmias
1.2.6.1  About ICD, CRT and CRT-D
1.2.7  Wolf-Parkinson-White Disease
1.3  Elective Surgery
1.3.1  Cosmetic Surgery
1.3.1.1  Laser Hair Removal
1.3.1.2  Port Wine Stains
1.3.1.3  Psoriasis
1.3.1.4  Varicose Veins
1.4  Ophthalmic Surgery
1.4.1  Capsulotomy Surgery
1.4.2  Laser In-Situ Keratomileusis (LASIK)
1.4.3  Laser Epithelial Keratomileusis (LASEK)
1.5  General Surgery
1.5.1  Fecal Incontinence
1.5.2  Gastroesophageal Reflux Disease (GERD)
1.6  Gynecological Applications
1.6.1  Hysterectomy
1.6.2  Menorrhagia
1.6.3  Fibroids
1.6.4  Bladder Neck Suspension
1.7  Urological Applications
1.7.1  Urinary Tract Stones
1.7.2  Benign Prostatic Hypertrophy
1.7.2.1  TUMT
1.7.2.2  TUNA
1.7.2.3  Photoselective Vaporisation of the prostate (PVP)
1.7.2.4  HoLAP
1.7.2.5  CoreTherm
1.7.2.6  TMX 3000
1.7.2.7  Prolieve
1.7.2.8  Prostiva RF Therapy
1.7.2.9  Water-Induced Thermotherapy
1.8  Tonsillectomy
1.9  Orthopedic Applications
1.9.1  Capsular Shrinkage
1.9.2  Carpal Tunnel Syndrome
1.9.3  Chondroplasty
1.9.4  Debridement
1.9.5  Epicondylitis and Tendinitis
1.9.6  Inflammatory Conditions
1.9.6.1  Nucleoplasty
 
See the report’s complete description, table of contents, and list of exhibits here.

 

Medical technology startup formation active

New medical technology development is active and driving the formation of many new medical technology companies. In MedMarket Diligence’s tracking of medtech startups (with an emphasis on medical device technologies as well as those complementary to, or directly competing with, them), over 280 companies have been founded since early 2006.  Below is a distribution of the startup companies by the area of clinical and/or technology focus (multiple possible; e.g., minimally invasive therapies and spine surgery):

startups_2006-2009

Source: MedMarket Diligence, LLC, "Medtech Startups Database."

 

The technologies represented in recently founded companies are listed here.