A Medical Device Daily

St. Jude Medical (St. Paul, Minnesota) reported receiving both regulatory approval and reimbursement approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its Durata defibrillation lead, which it calls a next-generation high-voltage lead.

The Durata lead incorporates a soft silicone tip with a larger surface area and a slightly curved right ventricle (RV) shock coil intended to enhance ease of use and handling for physicians implanting an implantable cardioverter defibrillator system in patients at risk for dangerously fast heart rhythms. It also incorporates Optim insulation, a hybrid insulation material unique to St. Jude Medical and created specifically for cardiac leads.

The company said that Optim insulation blends the biostability and flexibility of high-performance silicone rubber with the strength, tear resistance and abrasion resistance of polyurethane to provide increased durability, along with the flexibility and handling characteristics that facilitate device implantation.

The lead is the same size as the company's Riata ST Optim lead which it says is, at 7 Fr, the smallest-diameter high-voltage lead on the market. Small diameter leads may be especially helpful for patients with compromised blood flow, a narrow vasculature, or patients who need CRT-D systems that require three leads to be placed in a single vessel.

"The Durata lead represents St. Jude Medical's commitment to continuous innovation and improvement, incorporating new features based on physician feedback to better serve our physician customers and their patients," said Eric Fain, MD, president of St. Jude's Cardiac Rhythm Management Division. "This new lead combines next-generation technology with features designed to increase reliability and long-term durability and thereby reduce risks."

BioElectronics, Piramal in distribution pact

BioElectronics (Frederick, Maryland) BIEL) reported a new distribution agreement with India-based Piramal Healthcare (Mumbai) has been made for distribution of BioElectronic's ActiPatch product.

Piramal is one of India's largest companies with strong brand management and sales capabilities, according to BioElectronics.

"This is an important and significant order for BioElectronics," said Andrew Whelan, CEO of BioElectronics. We continue to be excited about developing strong sales in the international marketplace. Piramal Healthcare is an aggressive player and the right partner to help us roll our product out into one of the most populous countries in the world."

ActiPatch is a drug-free patch with an embedded battery-operated microchip that delivers weeks of continuous pulsed RF therapy for less than $1 a day. BioElectronics says that the patented ActiPatch system is designed to provide a cost-effective, home use method for reducing soft tissue pain and swelling, and to accelerate healing.

Piramal will distribute ActiPatch in the Indian market both on medical and retail levels beginning this month.

Large healthcare investment seen in India

Venture capitalists (VCs) and private equities (PEs) are expected to invest more than $8.5 billion in India in the next five years in at least five identified areas, such as biotechnology and life sciences, logistics, clean technology, film production and education, according to a new report.

A joint Assocham and Deloitte paper, "Indian venture capital — a future scenario," reveals that VCs and PEs, which, for long, have been choosing IT for investment purposes, have found huge investment opportunities in these five areas as regulatory barriers are gradually disappearing.

The report says it is anticipated that biotechnology and life sciences will attract about $1.5 billion in VC and PE investments by 2012.

Sajjan Jindal, president of Assocham, said that India has large opportunities in biotechnology and life sciences on the lines of retail and real estate. This sector has been attracting specialist VCs from global and domestic funds.

The U.S.-based Life Sciences Fund has recently invested about $20 million in a Hyderabad-based pharmaceutical company. Devices and diagnostics are other areas where investors are active.

RESPeRATE to sell via e-Costco

InterCure (Lod, Israel) reported that its RESPeRATE hypertension treatment device, designed to lower blood pressure, will now be sold through the online arm of Costco Wholesale (Issaquah, Washington).

"Costco aims to bring the best products available to our members at the lowest price," said Monica McArthur, buyer for Costco. "By offering RESPeRATE to our members, we are providing access to a proven therapy that fits in well with our current healthcare items and offerings."

RESPeRATE is available online at www.costco.com in a "value-added bundle" package.

"The availability of RESPeRATE on Costco.com signifies a new avenue of retail distribution for InterCure," said Scot Dube, InterCure VP of sales. "Providing consumers access to RESPeRATE through a wholesale club opens the door to a host of educated and loyal consumers looking for valuable options to manage their own health."

RESPeRATE is FDA-cleared for over-the-counter sale, and InterCure says it is the only medical device on the market clinically-proven to lower blood pressure through paced breathing therapy, the company said.

The company describes the device as using the body's natural tendency "to follow external rhythms, interactively guiding the user to effortlessly reduce their breathing rate to a 'therapeutic zone' of less than 10 breaths per minute." The breathing exercises with RESPeRATE relax the constricted muscles surrounding the small blood vessels, allowing blood to flow more freely and yielding a lasting reduction of blood pressure "within weeks."

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