FDA clears balloon catheters for coronary arteries

by emma 9. November 2011 11:54

Medtech FDA news

The FDA has approved Cordis Corporation’s Empira and Empira NC RX PTCA dilatation catheters for the treatment of coronary artery disease.

Both balloon catheters are designed to allow cardiologists to open patients’ narrowed coronary arteries during angioplasty procedures.

Dr Campbell Rogers, Chief Scientific Officer and Global Head of R&D at Cordis, said that the company “worked closely with physician-customers and incorporated their feedback into the design of these next generation devices. We believe the unique design of the Empira Balloon Catheters will meet physicians' needs and has the potential to improve patient outcomes”.

The two medical devices bring several design and technology alterations to Cordis’ portfolio of Empira balloon catheters. They feature the company’s next generation Duralyn Flex balloon material, which is 50% more flexible than the material used in the current Fire Star and Dura Star RX PTCA dilatation catheters, to improve crossability and recrossability, the ability to pass through a lesion.

Cordis Corporation is a Johnson & Johnson company, and develops and manufactures interventional vascular technology. The company works with interventional cardiologists, radiologists and vascular surgeons to treat patients with vascular disease.

The products are expected to be launched for sale in early 2012.

Medtech market report: France

by emma 28. October 2011 11:30

57340808

France is Europe’s biggest importer and exporter of medical devices. However, current reforms are driving cost reduction and efficiencies. Medtech Business in association with Espicom takes a look at the French market for medical technologies.

France is one of the top five medical device markets in the world, accounting for around 3.9% of the global market.* Within Europe, the market ranks behind Germany and is a similar size to that of the UK.

The country has a well-developed healthcare system, combining public hospitals with commercial clinics that are the main providers of elective surgical treatment. While the public sector is the largest purchaser of most diagnostic and therapeutic equipment, the private sector is the dominant purchaser of surgical equipment and supplies.

The high level of healthcare expenditure (11.8% of GDP) and the substantial health deficit are major concerns that have prompted various reform programmes aimed at curtailing costs and improving efficiency in the healthcare system. For this reason, the medical market is only likely to see moderate growth, rising from US$8.3 billion in 2011 to US$9.8 billion by 2016.

Despite several high-profile investment programmes, France continues to lag behind its European neighbours in some high-technology fields, most notably imaging and radiotherapy equipment. A second five-year cancer plan has now been launched which aims to increase the numbers of scanners.

With flagging domestic production in several sectors the French medical device market is increasingly reliant upon imports, which now account for around 80% of consumption. However, many imported products are re-exported to other countries.

 

The market in 2011

In 2011, the French medical device market (see Figure 1) is valued at US$8,280 million. Consumables is the largest product category, accounting for 20.9% of the overall market, followed by diagnostic imaging (19.8%).

Espicom estimates that the medical device market will grow at an average annual growth rate of 3.5% between 2011 and 2016 – bringing the total market value to US$9.8 billion by 2016.

Orthopaedic and prosthetic devices are expected to continue to be the most dynamic sector of the market, with growth forecast to be more than double the rate for the overall market. Conversely, diagnostic imaging is forecast to have the lowest growth during the 2011–16 period.

 

Predictions for market segments

Figure 2 shows Espicom’s predictions for the major segments of the medical device market.

1. Consumables. The market for medical consumables is estimated at US$1,729 million. The consumables market grew at an annual rate of 5.1% in US dollar terms between 2006 and 2010. Imports supply the greater part of the market. Espicom estimates the consumables market will continue to grow by an average of 3.5% over the next few years.

The wound care products market is forecast to grow at an average annual rate of 2.9% in US dollar terms during the 2011–16 period. Syringes, needles & catheters has been the fastest growing sector of the consumables market and will continue to be, with a CAGR of 4.1% to 2016.

2. Diagnostic imaging apparatus. The market for diagnostic imaging is estimated at US$1,636 million. The market grew at an annual rate of 2.8% between 2006 and 2010. France lags behind its European neighbours in the diagnostic imaging field, though the second cancer plan aims to increase provision of MRI, CT and PET scanners.

Imports supply the greater part of the market, though their market share is lower for radiation apparatus due to the strength of the domestic manufacturing industry. The USA and Germany are the major sources of supply. Espicom estimates that the imaging market will grow by an average of 2.1% between 2011 and 2016.

3. Dental products. The market for dental products is estimated at US$859 million, equal to 10.4% of the total medical device market. The dental products market grew at an annual rate of 4.2% between 2006 and 2010. It is forecast to grow at an annual rate of 3.5% over the next few years, taking the total to US$1,020 million by 2016.

4. Orthopaedic & prosthetic devices. The market for orthopaedic & prosthetic devices is estimated at US$1,336 million, equal to 16.1% of the total medical device market. The orthopaedic & prosthetic devices market grew at an annual rate of 9.2% between 2006 and 2010.

Imports have seen particularly high growth in recent years, though a corresponding increase in exports in this sector indicates that not all imported products are destined for the domestic market. The majority of orthopaedic imports are supplied by Switzerland and the USA.

The orthopaedic & prosthetic devices market is forecast to grow at an annual rate of 6.1% in US dollars over the next few years, taking the total to US$1,794 million by 2016.

5. Patient aids. The market for patient aids is estimated at US$1,131 million, equal to 13.7% of the total medical device market. The patient aids market grew at an annual rate of 4.5% between 2006 and 2010.

French imports of patient aids far exceed the value of the domestic market due to a high level of re-export activity, particularly for pacemakers. Switzerland and the USA are the leading suppliers of portable aids, whilst the USA and China are the major sources of supply for therapeutic appliances.

The patient aids market is forecast to grow at an annual rate of 3.9% over the next few years, taking the total to US$1,367 million by 2016.

 

Imports

The value of French medical device imports has recorded a steady rise over the past decade, reaching US$10.4 billion in 2008 before falling back to US$10.3 billion in 2009.

Imports of consumable items amounted to US$1,780.6 million in 2009. Imports fell by 1.0% over 2008 in US dollar terms (though they increased in euro terms). Syringes, needles, catheters & cannulae are the largest subcategory.

Diagnostic imaging imports totalled US$1,564.0 million in 2009, equal to 15.2% of the total. This was the weakest performing category in 2009, with a fall of 16.4%.

Imports of orthopaedic & prosthetic devices were worth US$1,549.1 million in 2009, equal to 15.1% of total medical device imports. This was the fastest growing category in 2009, with a rise of 26.6%. All three subcategories – artificial joints, orthopaedic appliances and other artificial body parts – recorded strong growth.

Patient aids are the largest import category, with imports worth US$2,624.1 million in 2009, equal to 25.5% of total medical device imports. Pacemakers accounted for 54.7% of imports in this category in 2009, but also accounted for more than half of patient aid exports.

The leading suppliers of French medical imports in 2009 were the USA, Switzerland and Belgium, with the UK ranking eighth as a supplier with imports worth US$288,964 (2.8% of the total).

 

Exports

In 2009, medical device exports registered a 3.0% fall in value to US$9.2 billion, having recorded steady growth in previous years with a CAGR of 6.8% for the 2005–2009 period.

In 2009, 69.5% of all French medical device exports were sent to the rest of the EU, with the Netherlands taking a 17.6% share, followed by Germany with 14.4%. The UK took 6.6% of French medical device exports.

Outside Europe, the leading destination is the USA, which accounted for 9.1% of exports. The USA is the leading destination for French exports of diagnostic imaging apparatus.

Next month, Medtech Business will look at the medical technologies market in Germany.

This article is based on information from Medical Market Outlook reports published quarterly by Espicom Business Intelligence. *All figures are in US $. For further details of the 66 markets covered, please visit www.espicom.com/outlookm1

Medical device company creates 79 jobs

by emma 25. October 2011 13:12

MB Medtech News

VistaMed’s investment of €7.2 million in R&D and product expansion will create 79 jobs, nearly doubling its workforce.

The Irish company designs, develops and manufactures catheters and complementary medical devices, exporting to the UK, Europe, US, South America and India.

Paddy Mulholland, Managing Director of VistaMed, said that the company “has continued to develop its capabilities and today we offer a comprehensive design development and manufacturing of innovative catheter solutions”.

The company’s investment is supported by the government through Enterprise Ireland.

Currently, 93 people are employed by VistaMed at its facility in Leitrim.

Endoscopic accessory approved in US

by emma 24. October 2011 15:04

MB Product News

The FDA has approved Crospon’s EF-800 external channel endoscopic accessory to deploy the company’s EndoFLIP catheters.

John O'Dea, CEO of Crospon, said that the medical device will enable the catheters to be used in “hard to access parts of the gastrointestinal tract”, for example, “measurement of stomas in the stomach created during bariatric surgery procedures”.

The company received FDA and CE Mark approval to market its EndoFLIP EF-900 gastric tube in July 2011, for use in bariatric surgery to provide support for sleeve gastrectomy, and to allow stomach decompression, gastric fluid drainage and removal.

Based in Ireland, Crospon develops minimally-invasive medical devices for monitoring, diagnosis and therapy in gastroenterology.

Export market report: the UK

by emma 19. September 2011 20:29

export market report

The UK medical device market is one of the biggest in the world, with growth relying predominantly on imports. But it is also a significant exporter of medical technologies. In the second of two articles looking at the domestic market, Medtech Business in association with Espicom takes a look at the UK medtech export market.

The UK is a significant global exporter of medical devices (including medical equipment and medical supplies) and remains among the world’s top 10. But the sector has faltered in recent years. Exports peaked in 2006 at US$7,238.5 million, but have fallen every year since then. In 2009, exports dropped to US$5,394.4 million – roughly the same level seen in 2005. The orthopaedic sector was hit especially hard in 2009. (For more details, see Figures 1–3.)

Consumables

Medical consumables were the largest individual export area in 2009, valued at $1,140.0 million,* or 21.1% of total exports. This was a fall of 3.8% compared with 2008, with a 2005–09 Compound Annual Growth Rate (CAGR) of –1.8%.

Consumables are defined as wound care products (medical dressings, sutures, sterile, surgical and dental goods), syringes, needles and catheters. Within this category, catheters and cannulae amounted to $279.7 million, virtually unchanged from 2008, but significantly lower than the 2005 level of $410.6 million. Exports of medical dressings amounted to $503.7 million, a fall of 8.3% compared with 2008.

figure1exportmarketreport

figure2exportmarketreport

Diagnostic imaging

Diagnostic imaging is not historically one of the UK’s stronger sectors. In 2009, UK exports of diagnostic imaging apparatus amounted to $1,131.3 million – 21.0% of the country’s total export market. In recent years, the electrodiagnostic sector has been its biggest source of growth. The 2009 total showed a fall of 0.1% compared with 2008, with a CAGR for 2005–09 of 5.4%.

Electrodiagnostic imaging exports amounted to $575.1 million, a rise of 23.4% over 2008 due largely to a big rise in MRI exports. Radiation apparatus exports were far lower at $83.4 million, although this too represented a strong increase of 28.2% on 2008 figures. Exports of imaging parts and accessories fell sharply in 2009, by 21.4% to $472.9 million.

Orthopaedic products

Exports of orthopaedic and prosthetic products saw a sharp fall in 2009. Exports totaled $1,231.5 million in 2008, but fell by 46.7% the following year to reach $656.2 million. Artificial joints fell by 67.1% to $71.5 million, while other orthopaedic/fracture appliances fell by 49.8% to $445.2 million.

As outlined in Medtech Business’s first UK market article (July 2011), imports in this sector also saw a sharp fall in 2009. Espicom suspects that much of the reduction is due to a change or relocation of multinational manufacturing and repackaging activities.

Patient aids

Exports of patient aids amounted to $1,054.5 million in 2009, a fall of 5.2% compared with 2008.

Portable aids fell by 8.0% to $762.1 million, while therapeutic appliances rose by 2.9% to $292.4 million.

figure3and4exportmarketreport

Dental products

Exports of dental products reached US$148.2 million in 2009 – 2.7% of the total. This is an increase of 4.1% over 2008; the total fell sharply in 2007, but has since recovered a little.

Dental cements amounted to US$70.2 million in 2009, a rise of 17.7% over 2008.

Leading destinations

In 2009, the single leading destination for UK exports was the US, with $768.1 million (4.2%) of total exports. The largest shipments to the US were diagnostic imaging products, which amounted to $188.8 million, 16.7% of exports in this sector. This was followed by consumables, which amounted to $136.5 million, 12.0% of exports in this product area. The US also received 31.7% of dental product exports, valued at $47.0 million. (See Figures 4 and 5 for more details.)

More than half of UK exports went to the EU-27 countries. Shipments totaling $3,016.7 million (55.9% of total exports) left the UK for the EU-27. The principal recipient within the EU was Germany, accounting for 13.4% of exports, valued at $720.6 million. Almost a quarter (22.3%) of diagnostic imaging apparatus exports went to Germany. Belgium was the single biggest importer of UK consumables (18.6%) and UK orthopaedic and prosthetic products (17.2%) – in both cases outstripping the US. Other leading destinations within the EU were France, Ireland and the Netherlands.

Next month, Medtech Business will look at the medical technologies market in France.

This article is based on information from Medical Market Outlook reports published quarterly by Espicom Business Intelligence.
*All figures are in US $. For further details of the 63 markets covered, please visit
www.espicom.com/outlookm1

figure5exportmarketreport

TextBox

Tag cloud

Calendar

<<  May 2013  >>
MoTuWeThFrSaSu
293012345
6789101112
13141516171819
20212223242526
272829303112
3456789

View posts in large calendar