Thursday, November 30, 2006

Global Growth in Refractive Surgery

Shift in use of refractive types, growth by country...

Refractive surgery is performed using a number of surgical techniques, each designed to minimize the patient’s dependence on eyeglasses and contact lenses. Although there are many options to improve refractive error making it a complex field for the surgeon, while at the same time offering a broad range of options to treat each patient’s unique needs, some approaches will grow at a greater rate while other refractive surgery options will be cannibalized by these faster growing techniques or they will be relegated to serving the needs of niche populations. For those techniques that serve a particular niche population, manufacturers will struggle with how to maintain visibility for these sub-population therapies while ensuring that clinical competence will be maintained at a level to allow the surgeon to deliver the outcomes that are feasible.

Numerous factors come into play as the market for refractive surgery evolves:

  • Clinical Outcomes – documented clinical advantage will not only encourage physicians to embrace new approaches to refractive surgery, it will help clinicians to determine the subset of patients that are most likely to benefit by one technique over another.

  • Physician Education – the speed with which surgeons can be trained on the new techniques

  • Access – how rapidly will the market adopt the technology that is necessary to perform the procedure and how quickly will the market be penetrated

  • Patient Education – the ability of physicians and marketing efforts by manufacturers to inform patients of various options

  • Cost – Significant differences in price to the patient as well as cost associated with training and equipment by physicians and ambulatory care centers

  • Reimbursement – insurers willingness to pay for such procedures will continue to be a factor in a patient’s decision to undergo refractive surgery

The net effect is that custom LASIK will soon constitute a dominant share of refractive procedures.



Globally, the U.S. dominates the market for refractive surgery products, but strong growth is evident in many countries.



Tags: medtech, ophthalmology, refractive, LASIK

Wednesday, November 29, 2006

Orthopedic Biomaterials Market Segment Growth


The worldwide market for orthopedic biomaterials -- allografts, synthetic bone substitutes, bone growth factors, polymers, ceramics, etc. -- is growing steadily due to a concurrent evolution of surgical procedures, the emergence of innovative products and a dynamic and growing patient population. Select segment growth in this worldwide market is shown at right.

Data drawn from forthcoming MedMarket Diligence report, "Emerging Trends, Technologies and Opportunities in the Markets for Orthopedic Biomaterials, Worldwide." (publishing Nov/Dec 2006)

Tags: medtech, orthopedic, biomaterial

Saturday, November 04, 2006

Drug-Eluting and Bioabsorbable Stents

>> See updated coverage of drug-eluting and bioabsorble stents on the current blog at mediligence.com/blog.

From October 2006 MedMarkets

Developers of Cardiovascular Drug-Eluting and Bioabsorbable Stents

Company

Stent

Drug

Status

Abbott Vascular

BVS (bioabsorbable)

Everolimus

ABSORB first-in-man clinicals began 3/06

Xience V (distributed by Boston Scientific as Promus)

Everolimus

CE Mark 1/06; European launch 10/06; U.S. launch expected 2008

ZoMaxx

Zotarolimus

Development discontinued 10/06

Avantec Vascular

Duraflex

Pimecrolimus

In development

Beijing Lepu Medical Device

Ton Xin Partner

Sirolimus

Launched in China 11/05

Biosensors International

Axxion

Paclitaxel

CE Mark 7/05

BioMatrix

Biolimus A9

In trials; expects CE Mark in 2006

Biotronik

Absorbable Metal Stent (AMS)

Completely bioabsorbable magnesium alloy

In clinicals (PROGRESS)

Blue Medical Devices

Melissa

Melatonin

In clinicals (NOBLESSE)

Boston Scientific

Taxus Express2

Paclitaxel

CE Mark 1/03; FDA approval 3/04

Taxus Liberté

Paclitaxel

CE Mark 9/05; FDA approval expected 2006

Conor Medsystems

Corio

Pimecrolimus

GENESIS trial began 5/06

CoStar

Paclitaxel

CE Marked 2/06; U.S. launch expected 2007/2008

CoStar II (bioabsorbable polymer)

Paclitaxel

In clinicals

SymBio

Pimecrolimus and paclitaxel

GENESIS trial began 5/06

Cordis (J&J)

Cypher

Sirolimus

CE Mark; FDA approved; U.S. launch 4/03

Cypher Neo (for smaller arteries)

Sirolimus

U.S. launch expected 2007

Cypher Select

Sirolimus

CE Mark in 2003

Cypher Select Plus

Sirolimus

International launch (outside U.S., Japan) 9/06

CorNova

Chronoflex DES

(Undisclosed)

In development

Devax

Axxess (bifurcated)

Biollimus A9

Clinicals (DIVERGE) began 6/06

DISA Vascular

Stellium

Paclitaxel

Clinicals to begin 2007

Endovasc-TissueGen

(Undisclosed; fully resorbable)

Prostaglandin E-1 antirestenotic

In development

Estracure

(Undisclosed)

17-(beta)-estradiol

In clinicals

JW Medical Systems

Excel (bioabsorbable)

Rapamycin

U.S. Phase IV clinicals began 6/06

Medtronic

Endeavor

Zotarolimus

CE Mark 7/05; U.S. launch planned 2007

MicroPort Medical

Firebird (cobalt alloy polymer)

Sirolimus

Approved in China 2003

MIV Therapeutics

(Undisclosed)

(Undisclosed)

Vascore Medical (acquisition agreement announced 9/06) stents to carry MIVT coatings

OrbusNeich

Cura (bioabsorbable polymer)

Sirolimus

In clinicals (Singapore)

Genous Bio-engineered R Stent (bioabsorbable)

Coated with antibody that captures patient’s own endothelial progenitor cells

CE Mark 8/05; HEALING III trials began 2006, 9-mo. results expected 1Q07

Relisys Medical Devices

(Undisclosed)

Paclitaxel

In clinicals

REVA Medical

REVA Medical Resorbable Stent

Balloon-expandable, drug-eluting polymer

First-in-man trials to begin 2006

Sahajanand Medical Technologies

Infinnium

Paclitaxel

CE Mark 12/05

Infinnium Bioabsorbable

Paclitaxel

In clinicals (SIMPLE registries)

Supralimus (bioabsorbable)

Sirolimus

In clinicals (SERIES)

Sorin Biomedica Cardio

Janus Flex

Tacrolimus

CE Mark; launched in Europe 2/06

Terumo

Nobori

Biolimus A9

Clinicals began 6/05; product launch expected late 2006

Translumina

Yukon ChoiceDES (polymer-free)

Rapamycin

International launch 4/06

Vascular Concepts

ProNova

Sirolimus

Available internationally

X-Cell Medical

Ethos

17-(beta)-estradiol

In clinicals (ETHOS); to incorporate SurModics’ Bravo polymer matrix per 9/06 licensing agreement

Xtent

Custom NX

Biolimus A9

In clinicals; European launch expected 2007, U.S. in 2009

Source: MedMarket Diligence, LLC

Tags: medtech , stents , drug-eluting

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