A Medical Device Daily

Sorin Group (Milan, Italy) reported Health Canada Therapeutic Products Directorate (TPD) approval to market the Reply family of dual and single chamber rate adaptive pacemakers.

The company said that the Reply is the world's smallest dual chamber pacemaker at only 8 cc's.

Reply integrates Sorin Group's new SafeR pacing mode, based on the proven AAISafeR pacing mode first introduced to North America in 2005. Designed to titrate ventricular pacing, SafeR switches from AAI to DDD in case of AV block detection, and has been shown to reduce unnecessary pacing in both Sinus Node Disease and unselected AV Block patients.

The CAN-SAVE R trial, currently being conducted in 10 centers across Canada, demonstrated that SafeR was able to reduce ventricular pacing to less than 1% in the overall population, ranging between 0% in patients without AV block and 1% in patients with AV block (median values).

In addition to SafeR, the Reply pacemaker delivers enhanced software for advanced, automatic features such as SmartCheck, which lets the user automate follow up tests, as well as providing comprehensive data reporting, analysis and recommendations.

Felix Ayala-Paredes, MD, chief of electrophysiology services at CHUS-Fleurimont Hospital (Sherbrooke Quebec), implanted the first Reply pacemaker in Canada. "Recent device-based therapy guidelines highlight the new standard of care which is to minimize unnecessary ventricular pacing. The Reply pacemaker was a good choice for this patient. I am confident that the SafeR algorithm will minimize ventricular pacing and I am especially impressed with the combination of small size and longevity."

Biofield ships to Latin American distributor

Biofield (King of Prussia, Pennsylvania) reported that it has shipped the initial order of its Biofield Diagnostic System (BDS) for the early detection of breast cancer units to an exclusive distributor representing the Mexican, Central and Latin American markets. The distributor, MacKay Health Systems, (MHS), a company primarily made up of nationals from the licensed territories, acquired the rights to Mexico and various Central & Latin American countries via an exclusive distribution agreement it entered into with MacKay Innotech, (MHK; Hong Kong). MKH holds a worldwide master license from Biofield to manufacture and distribute the BDS units.

Under the terms of distribution agreement, MHS will pay MHK a non-refundable licensing fee of $1 million and 10% royalty of gross revenues. Terms require the distributor to purchase a minimum number of units per quarter, per country. The specific countries are: Aruba, Belize, Costa Rica, Dominican Republic, El Salvador, Guadeloupe, Guatemala, Haiti, Honduras, Martinique, Mexico, Netherland Antilles, Nicaragua, Puerto Rico. Saint Martin and Saint Pierre & Miquelon. The company has, this week, shipped the initial order, as per the terms of the agreement. Regular recurring shipments are expected to follow.

Biofield has acquired 10% of ValiRx listed on the UK's AIM stock exchange together with the right for the exclusive worldwide distribution rights outside of Belgium, for ValiRx plc's human papilloma virus (HPV) diagnostic test for cervical cancer as well as for ValiBio Hypergenomics.

The company also reported its intention to change its name to MacKay Life Sciences. The name change is also meant to precede closing of the previously announced intention of MHK to vend back into the company, the master license MHK holds, in addition to the rights and agreements that MHK has amassed during its term as the master licensee, which should result in greater revenues being realized by the public company.

ETC's BioMedical unit accredited in Japan

Environmental Tectonics' (ETC; Southampton, Pennsylvania) BioMedical Division reported that the Japan Ministry of Health, Labor and Welfare (MHLW) has given accreditation to ETC as a foreign manufacturer in Japan.

ETC worked closely with the company's Japanese distributor – Koike Medical – to help ensure that the company's monoplace hyperbaric chambers passed every certification requirement. Obtaining the accreditation further promotes placement of Bara-Med chambers in Japan.

ETC manufactures the Bara-Med and Bara-Med XD hyperbaric chambers.

In addition to their regular use in clinical treatments at medical facilities around the world, ETC's hyperbaric chambers are routinely involved in research on new indications for which hyperbaric oxygen therapy holds promise.

Eric Sprague, Director of Asia Sales for ETC, commented, "We are pleased to see ourselves leaving a larger footprint on the Asian Market. Koike Medical has been a long time partner with ETC and has placed a significant number of ETC's monoplace chambers in Japan."

InPlace enters contract with exlclusive agent

InPlace Medical Solutions (IMS; Houston), a video-telemedicine offshore medical service, has contracted Atlas Merger SDN.BHD as its exclusive agent for Malaysia, Brunei and Indonesia. Atlas Merger, a well-recognized name in the region, will be responsible for marketing and contract management of IMS.

"We are pleased to announce that Atlas Merger will represent InPlace Medical in this important part of Southeast Asia," said Shannon Caldwell, executive director for Offshore and Remote Services at NuPhysicia (Houston), the company operating the InPlace Medical Solutions brand. "Working globally, the offshore oil and gas industry appreciates how InPlace Medical provides improved medical services while controlling costs and improving rig productivity," said Caldwell.

InPlace combines specially trained remote duty paramedics, enhanced medical inventory and advanced video telemedicine technology to bring expanded physician care directly to the rig. This better manages rig workforce health and lowers transportation risks and costs. Offshore oil operators and drilling contractors benefit from reduced operating expenses and higher workforce productivity, according to the company.